Clinical trials are medical research studies involving people that seek to prevent disease, find treatments, diagnose diseases, or control symptoms. Trials on experimental drugs, such as the GERD study, aim to identify if the drug is safe, has side effects, works better than currently used treatments, and helps users feel better. Experimental drugs are not tested on people unless they show promising results in laboratory tests.

GERD is a chronic condition in which the liquid contents of the stomach regurgitate or back up into the esophagus. This liquid can inflame and irritate the lining of the esophagus, causing symptoms such as heartburn, sour taste in the back of the throat, a dry cough and interrupted sleep. If left untreated, it can also lead to esophageal cancer.

Treatments include diet changes and medication. While many drugs are available over-the-counter to treat heartburn, more potent prescription alternatives are limited. One common prescription treatment is Reglan (metoclopramide), however the drug carries an FDA black box warning of a serious, involuntary movement disorder known as Tardive Dyskinesia. For sufferers of GERD, identifying a safe and effective treatment could be life changing.

SOURCE: Reglan Side Effects › Participants needed for clinical trial on new GERD treatment

Mary suffers from gastroparesis, a condition in which the stomach takes too long to empty its contents. It is a debilitating condition that can strike anyone, but people with diabetes are more susceptible. As many as 50 percent of people with type 2 diabetes and 20 percent with type 1 diabetes have the gastrointestinal disorder.

Treatment for gastroparesis can be discouraging. Some people can manage the condition by limiting their diet. Others must rely on medications, such as Reglan (metoclopramide), which can have serious side effects such as a involuntary movement disorder known as Tardive Dyskinesia.

With little hope left, Mary chose another option – to have an innovative new surgery available at Texas Tech University’s Paul Foster School of Medicine. As part of the surgery, doctors will implant a device called the Enterra into Mary’s abdomen. “It’s a very powerful anti-nausea, anti-vomiting tool,” gastroneurologist Richard McCallum, founding chair at the Paul Foster School of Medicine, told KTSM-TV.

Mary’s surgery will be third of its kind performed at the El Paso medical center. “Even if my symptoms got 50 percent better, it would be a huge change in my day,” Mary said.

SOURCE: Reglan Side Effects › Woman to have innovative new surgery to treat gastroparesis

Most people dismiss the idea that they even have the acid reflux condition because they have none of the classic symptoms, but many sufferers of chronic cough may find relief when treating themselves for GERD.

One man wrote to popular medical question-and-answer columnist Dr. Gott about his dry, hacking cough that seemed to last the entire winter. His allergist gave him a thorough exam and offered numerous suggestions. Then he added, if all else fails, try an over-the-counter heartburn medication. The reader did, and his symptoms subsided.

“My hat is off to your allergist for thinking outside the box of his specialty and doing everything he could to help you,” Dr. Gott replied to the reader.

GERD is a chronic digestive disease that affects millions of Americans. It can be treated with lifestyle changes and over-the-counter treatments such as antacids and medications. However, some may need stronger medications available only by prescription, such as Reglan (metoclopramide). As with many drugs, there are risks to Reglan.

Last year, the Food and Drug Administration (FDA) placed a black box warning on Reglan after numerous reports of patients suffering from an involuntary movement disorder known as Tardive Dyskinesia.

For more information on diagnosing or treating GERD, contact your health care professional.

Sources:
Go Erie
Mayo Clinic

SOURCE: Reglan Side Effects › Chronic cough may be symptom of GERD

Such research could help the approximately 5 million people who suffer from gastric mobility disorders such as gastroparesis and chronic intestinal pseudo-obtruction. People with these conditions “suffer from the debilitating effects of chronic nausea, vomiting, abdominal pain, malnutrition, dehydration, and weight loss. Many cannot eat a bite of food or take a sip of fluid without getting sick. Some patients are disabled and completely homebound, relying on artificial nutrition in order to stay alive,” according to G-PACT.

Treatments for these conditions are mostly limited to medications, like Reglan (metoclopramide), which cannot be used on a long-term basis without putting users at risk for serious side effects.

“Having been a skin cancer
 sufferer, we would expect Mr. McCain to have a better understanding of
 the struggle that chronic disease sufferers have to live a normal life,
 maintaining careers, families and health,” the petition states. “We also implore others in public life to work to help in our fight to 
gain further understanding, awareness and most importantly cures of GI 
motility disease that all too often causes pain and starvation to 
individuals who did not seek such illness and who did not choose this
 fight.”

To join this fight, sign the petition.

Source, About.com

SOURCE: Reglan Side Effects › Gastroparesis group to petition Sen. McCain about criticism of IBS funding

However, it took more than a decade for the Food and Drug Administration (FDA) to place a black box warning on the medication, Reglan. A black box warning is the strongest warning issued by the FDA and is placed on drugs that have potentially harmful or deadly side effects. Meanwhile, the drug was dispensed 6.5 million times in 2008 to an estimated 2 million Americans.

Reglan, also known by the generic brand metoclopramide, is available in formulations including tablets, orally dissolving tablets, syrups and injections. It works by increasing muscle contractions in the upper digestive tract, which speeds up the rate at which the stomach empties into the intestines. But it also can lead to involuntary movements of the muscles, causing users to smack their lips, thrust their tongue, blink and bulge their eyes, jerk their heads, and purse their lips. Tardive Dyskinesia is debilitating and often symptoms don’t subside even after the medication has been discontinued.

So, why would it take the FDA so long to issue a warning about a medication with published reports of serious adverse events? Herb Denenberg with the Philadelphia newspaper The Bulletin, says delayed action by the government agency is not uncommon.

“This delayed warning of a drug’s danger is all too typical. It took (13) years for the FDA to sound this alarm put forth by Worst Pills, Best Pills News in 1996, thus needlessly exposing many millions to a serious side effect that might plague them for life, and might have been avoided if they were properly warned,” Denenberg argues. “I’d add to that warning. First, everyone should understand, as the Physicians’ Desk Reference explains, that side effects from the drug are unpredictable. The medication guide for Reglan states: ‘It is not possible for your doctor to know if you will get TD [Tardive Dyskinesia].’ So even short-term use may cause Tardive Dyskinesia. Second, the patient – not the doctor or the FDA – should decide whether the benefits of the drug are worth the risks of taking it. The patient should ask the doctor if there are other treatments, including other drugs that might be better options, or perhaps non-drug treatments that might be much safer.”

SOURCE: Reglan Side Effects › Why did FDA take so long to place black box warning on Reglan?

Metoclopramide

Tardive Dyskensia is a condition in which a person develops involuntary movements that can include lip smacking, facial grimacing, tongue thrusting, eye blinking and bulging, head jerking, and involuntary movements of the fingers. It can be debilitating for those who suffer from the condition. Metoclopramide carries the greatest risk when it is taken for 12 weeks or longer. Women and the elderly are at higher risk, and there is known know cure. Even after stopping the medication, the symptoms may persist.

In early 2009, the Food and Drug Administration (FDA) issued a black box warning – the agency’s sternest warning reserved for drugs that carry a risk of serious adverse events – on metoclopramide, urging doctors to avoid long-term use of the drug except in rare cases where the benefits outweigh the risks. That warning came too late for many patients, who are now handicapped because of the medication.

SOURCE: Reglan Side Effects › Black box warning on Reglan came too late for some

Cancer of the esophagus is one of the 10 most common cancers, yet there is no good treatment for the disease. Most people who have been diagnosed with esophageal cancer also have a long history of heartburn. Heartburn occurs when toxic acid from the stomach splashes up into the esophagus. Over time, if left untreated, this constant bathing of stomach acid can damage tissue in the esophagus, a condition known as Barrett’s esophagus.

Barrett’s esophagus is generally treated with the same medications used to treat heartburn and GERD, including Reglan (metoclopramide).

The damaged tissue of Barrett’s esophagus cannot be reserved and if left untreated can lead to esophageal cancer. It is also impossible to remove the damaged tissue, which means the risk of cancer is always a threat.

However, Hans Clevers of the Hubrecht Institute had a hunch. He believed that since the cells in Barrett’s esophagus are very similar to the cells that line the colon, they might share some qualities that could lead to a better understanding in the treatment of Barrett’s esophagus. Researchers determined that the anti-Alzheimer’s drug DBZ, currently in clinical trials, had side effects that affected the lining of the lower colon. Using rat models, Clevers observed the effects of DBZ on Barrett’s esophagus tissue and found that the drug not only halted the growth of Barrett’s esophagus, in some cases it also completely destroyed the mutant tissue.

The treatment is far from human trials, but it still offers hope for a better treatment for Barrett’s esophagus and esophageal cancer in the future.

SOURCE: Reglan Side Effects › Alzheimer’s drug may treat Barrett’s esophagus, esophageal cancer

“This is a significant finding, as it shows that loss of the enzyme that makes carbon monoxide is the actor in this process and that it provides us with a clear approach toward a possible new therapy for this condition,” says Gianrico Farrugia, M.D., Mayo Clinic gastroenterologist and lead investigator on the study, in a Science Daily report.

Gastroparesis is a serious condition that causes pain, nausea, vomiting, stomach spasms, weight loss and nutritional deficiencies. It is usually treated through diet, medication or surgery. Treatments are often unreliable or not recommended for long-term use. Finding a way to reverse the condition would give hope to millions of people who are suffering from the effects of gastroparesis.

As part of the study, researchers studied 10 mice that exhibited delayed gastric emptying. Five were given carbon monoxide by inhalation (100 parts per million) for six hours daily. Within three weeks, gastroparesis was reversed in the mice who received the therapy. While the metabolite that normalizes gastric functioning was not known, using carbon monoxide to treat the mice was a hunch on the part of scientists based on previous studies by the team that showed that gastroparesis is associated with the loss of up-regulation of the heme oxygenase-1 (HO1) and an increase in oxidative stress. In the previous study, the team noted that when they induced HO1 production signs of oxidative stress dropped and gastroparesis was restored.

SOURCE: Reglan Side Effects › Study may lead to new treatment of gastroparesis

The Fifth Circuit upheld a lower court ruling that Actavis Inc., could face claims made by Julie Demahy, of Louisiana, who said the drug maker should have warned her of risks of serious adverse events associated with metoclopramide, a medication used to treat heartburn, GERD and gastroparesis, and known by the brand name Reglan. Demahy claimed she suffered a debilitating movement disorder known as Tardive Dyskinesia after taking metoclopramide, and that the drug company failed to alert her of any risks associated with the medication or to change the drug’s labeling to warn of the risk of developing the disorder.

Last year, the Food and Drug Administration (FDA) ordered a black box warning on metoclopramide prescriptions after reports of Tardive Dyskinesia were associated with use of the medication. Long-term use of 12 weeks or more increased one’s risk of developing the disorder to 20 percent or more.

SOURCE: Reglan Side Effects › Ruling: patients may sue generic drug makers under state law

Some studies show that patients who take the medications for more than 12 weeks, as well as the elderly, are as much as 20 to 70 percent at risk for developing Tardive Dyskinesia. Medications like Reglan (metoclopramide) may mask the symptoms, which can become more prevalent after the medication is discontinued. Even after patients stop taking the drugs, symptoms may persist.

Symptoms include involuntary lip smacking, blinking, raising eyebrows, tongue twitching and protrusion, toe tapping, and jerking, repetitive, involuntary motions of the fingers, hands, arms, legs and/or torso. For some, the movements are slight and hardly noticeable. For others, the involuntary movements are severe and debilitating.

Unfortunately, there is no way to predict who will suffer the symptoms of Tardive Dyskinesia, which makes it even more important that patients understand the risks of their medication. Recently, the Food and Drug Administration (FDA) issued a black box warning, its most serious warning, on Reglan (metoclopramide) because of the risk of Tardive Dyskinesia especially with long-term use of the medication. An estimated two million people take some form of Reglan (metoclopramide), and may be at risk for developing the movement disorder.

SOURCE: Reglan Side Effects › Movement disorder linked to common medications

GERD is chronic heartburn, a condition caused when food or liquid travels backwards from the stomach to the esophagus causing a burning sensation in the throat or chest. It can be bothersome to adults, and cause problems for infants, making them irritable and unwilling to eat.

As many as 70 percent of all babies spit up on occasion, which is normal and doesn’t require treatment. The number of infants who actually suffer from GERD is thought to be as low as five percent. Yet, diagnosing irritable babies with GERD seems to be the trend, says Dr. Eric Hassal, a gastroenterologist at the B.C. Children’s Hospital in Vancouver. And that can lead to over-prescribing of medication that some argue has not been sufficiently studied, especially in pediatric patients.

“Now everybody’s saying, ‘Oh, they must have reflux because they are spitting up. And we’ve got these great brand new drugs that we should give your baby’,” Dr. Hassall told CTV News.

While medication is a viable treatment for people who suffer from heartburn and GERD symptoms, like all medications, they should be taken with caution. For example, one common GERD medication prescribed for both adult and pediatric patients, Reglan (metoclopramide), recently received a black box warning by the FDA after numerous patients who took the drug reported suffering from a serious debilitating movement disorder known as Tardive Dyskinesia.

That is one reason why Dr. Hassal recommends parents first take a non-medicinal approach to treating their babies who appear to be suffering from symptoms of GERD, which includes keeping the baby in an upright position for as long as possible after meals, avoiding tobacco smoke, swaddling the baby, and carrying the baby in a carrier close to your body. Diet changes and better burping practices can also help improve symptoms.

SOURCE: Reglan Side Effects › GERD a trendy diagnosis for fussy infants

Generic drug makers successfully argued in district court that a Food and Drug Administration  (FDA) regulation that required generic drugs to carry the same labels as their brand-name equivalents conflicted with the failure-to-warn claims. However, the Eighth Circuit Court overturned the dismissal resulting in a victory for Mensing.

It proved too late for Mensing, but earlier this year the FDA issued a black box warning for Reglan (metoclopramide), advising physicians to avoid long-term use of the drug except in rare cases where the benefit outweighs the risks. Long-term users and elderly patients, especially women, are at an increased risk for developing the serious movement disorder. There is no known cure for Tardive Dyskinesia, even after the medication has been discontinued.

Patients currently taking Reglan or the generic metoclopramide should discuss any risks or side effects with their health care provider.

SOURCE: Reglan Side Effects › Makers of generic Reglan liable for inadequate warning labels

Click here to view the embedded video.

People of all ages, shapes and sizes suffer from gastroparesis. The National Institutes of Health estimates as many as 10 million people are living with gastroparesis. Because of the lack of medical education and improper diagnosis, many more may be suffering in silence. Symptoms include abdominal cramps, nausea and vomiting and can result in dehydration, electrolyte imbalances and malnutrition.

Treatments include medication, such as Reglan (metoclopramide), and surgery. Those with gastroparesis suffered yet another blow this year when the Food and Drug Administration (FDA) issued a black box warning on Reglan after numerous cases of a serious movement disorder known as Tardive Dyskinesia were reported in patients who took Reglan. Long-term users were as much as 20 percent at risk of developing the condition.

Because treatments offer only temporary benefits to patients, activists groups such as the Gastroparesis Awareness Campaign Organization are working to raise awareness in hopes of finding better, safer treatments and, eventually, a cure.

SOURCE: Reglan Side Effects › Gastroparesis organization raises awareness through video

One popular choice in acid reflux treatment are pills known as Proton-Pump Inhibitors. “The dark side of Proton-Pump Inhibitors, because we’ve used so much of them for such a long period of time, is beginning to emerge,” says Dr. Henri Roca of LSU Health Sciences Center’s Family and Integrative Medicine during a interview with WWL-TV in New Orleans.

Proton-Pump Inhibitors are available both by prescription, such as Nexium, and over-the-counter, as Prevacid, Omeprazole and Prilosec. These drugs are recommended for use for seven or eight weeks. When someone takes them for 12 weeks or longer, problems arise.

When taken long term, Proton-Pump Inhibitors can inhibit the body from properly absorbing calcium, which puts long-term users at high risk for osteoporosis. It also interferes with the body’s defense mechanisms by clearing up bacteria that benefits the stomach and intestines, thus contributing to more gastrointestinal infections. And recently, the Food and Drug Administration (FDA) issued a warning about the combined use of the heart medication Plavix with Proton-Pump Inhibitors after tests showed that the Proton-Pump Inhibitors reduced the effectiveness of Plavix.

Another type of medication used to treat heartburn symptoms available only by prescription is Reglan (metoclopramide). Again, long-term (12 weeks or more) use of Reglan can have serious consequences. Early this year the FDA issued a black box warning on Reglan and other metoclopramide medications after numerous cases of a serious movement disorder known as Tardive Dyskinesia had been linked to use of Reglan. Tardive Dyskinesia can be debilitating and the symptoms may not stop even after the medication has been discontinued.

Doctors advise patients to talk with the doctors about their symptoms and any medications they may be taking. According to Dr. Roca, your symptoms may be caused by a number of ailments, and there may be safer and more effective ways to treat your heartburn symptoms.

SOURCE: Reglan Side Effects › Long term use of heartburn drugs can be dangerous

Another chronic sneezer, 22-year-old Caileen Wendel of Pennsylvania, says she sympathizes with Johnson because she has suffered from the same sneezing symptoms for five years. Doctors were also baffled by her condition and after 40 emergency room visits, Wendel finally found a doctor willing to try something new. Dr. Larry Geisler with St. Mary’s Hospital in Langhorne, Pa., prescribed the anti-nausea drug Reglan (metoclopramide) with Benedryl. Within five minutes, Wendel’s sneezing stopped.

“I don’t know if it’s a fix-all, but it happened to work and it worked for Caileen,” Dr. Geisler told NBC Philadelphia. It is a blessing that Wendel’s treatment is working, giving her life back. “To be able to stop something that I have no control over is probably one of the best feelings in the world,” she said. Both Wendel and Dr. Geisler hope that the same combination of medications can help Johnson.

Wendel says her symptoms return from time to time, and when they do she gets back on the combined Reglan-with-Benedryl meds and the sneezing stops. But, staying on the drug long term is not an option for Wendel. While Benedryl is available over-the-counter, Reglan requires a prescription, and carries a black box warning, issued earlier this year by the Food and Drug Administration (FDA). The warning was issued after the FDA received numerous reports of a serious movement disorder known as Tardive Dyskinesia in people who had taken Reglan. Studies have shown that people who take the drug for more than 12 weeks are as much as 20 percent at risk for developing the condition.

SOURCE: Reglan Side Effects › Reglan may calm chronic sneezing fits, but long-term use risky

In a Phase IIb trial, Addex’s ADX10059 increased performed well in the treatment of gastroesophageal reflux disease (GERD). The four-week trial, which comprised 103 patients, showed ADX10059 significantly increased the number of symptom-free days for patients that took the drug compared to patients on a placebo. Patients involved in the trial had previously responded well to a group of drugs widely used for combating acid reflux called proton pump inhibitors, (PPIs).

The trial also showed that the medication was well tolerated among those in the trial. While adverse events were reported more often among those taking ADX10059 than the placebo group, the company reports that the vast majority of events were mild and none were described as severe. Participants who took ADX10059 also indicated a reduction in sleep disturbance compared to those in the placebo group, according to a patient questionnaire.

Addex says it has also completed patient recruitment for another trial of ADX10059, which combines the medication with PPIs. Results on that trial are expected in January 2010.

The results set Addex up to license the drug to a larger pharmaceutical company, which is anticipated sometime in 2010. Some estimates say a partnership could generate as much as $1.25 billion in annual sales.

Source: Addex Pharmaceuticals

SOURCE: Reglan Side Effects › New heartburn medication meets expectations in drug trial

Side effects of nizatidine include abdominal pain, diarrhea, dizziness, gas, headache, indigestion, inflammation of the nose, nausea, pain, sore throat, vomiting and weakness.

The new generic medication offers another drug choice for patients who suffer from uncomfortable and sometimes painful symptoms of GERD. Another popular prescription drug in the treatment of GERD includes Reglan (metoclopramide). Earlier this year the FDA issued a black box warning on metoclopramide products following reports of an involuntary movement disorder known as Tardive Dyskinesia in patients who took metoclopramide for more than 12 weeks.

People who suffer from Tardive Dyskinesia experience involuntary movements of their muscles which can include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers.

This fall, the FDA approved an orally dissolving tablet form of metoclopramide under the brand name Metozolv ODT. That medication also falls under the same black box warning as other metoclopramide products, such as Reglan. Nizatidine is not the same medication as metoclopramide, and thus does not fall under the same FDA warning.

Source: FDA

SOURCE: Reglan Side Effects › FDA approves generic GERD treatment

GERD is a condition thought to be the result of an acid burn caused by stomach acid splashing up into the esophagus. It is often treated with medications that reduce stomach acid, such as Reglan (metoclopramide). But the new study squashes the “acid burn” belief. “Chemical injuries develop immediately,” the study’s leader, Dr. Stuart Spechler, told Reuters. “If you spill battery acid on your hand, you don’t have to wait a month to see the damage.”

Researchers say that the findings from the new study could change the way GERD is treated. “Currently, we treat GERD by giving medications to prevent the stomach from making acid,” said Dr. Rhonda Souza. “But if GERD is really an immune-mediated injury, maybe we should create medications that would prevent these cytokines from attracting inflammatory cells to the esophagus and starting the injury in the first place.”

An estimated 40 percent of Americans experience symptoms of GERD at some point, and as many as 20 percent suffer from persistent symptoms. If left untreated, GERD can cause esophageal cancer.

SOURCE: Reglan Side Effects › New study may lead to different treatments for GERD

Hiccups are usually a short-lived condition, with bouts lasting no longer than 30 hiccups. While the cause is relatively unknown, some things can trigger an episode of the hiccups, such as an overly full stomach (from too much food, alcohol or air), sudden temperature changes, smoking cigarettes, excitement or stress, and some medications. But for some, hiccups can last hours or even days. One man in Iowa reportedly had hiccups that lasted 60 years. Constant hiccups can make eating, drinking and sleeping difficult, and may require medical treatment to get under control.

If you suffer from hiccups that last an unusually long time, seek medical attention. Your doctor may first want to rule out any underlying medical conditions. While unlikely the case, constant hiccups may be a symptom of a more serious problem, such as laryngitis, gloiters, tumors in the neck, infections near the diaphragm, hiatus hernia, kidney failure, ear infection, aortic aneurysms and multiple sclerosis.

While rarely performed, hiccups can be treated with surgery. One type of surgery involves a nerve block that stops the major nerve supply for the diaphragm from sending signals to the diaphragm. The other involves implanting a pacemaker into the diaphragm to control contractions in the diaphragm. Most doctors, however, will choose a less invasive route, which may include medications.

Drugs that have been shown to reduce hiccups are the antipsychotic chlorpromazine, antispastic medication baclofen and metoclopramide. While medications may offer relief, patients should be aware of any serious side effects. For example, metoclopramide carries an FDA black box warning about the risk of a serious movement disorder known as Tardive Dyskinesia.

If your hiccups are persistent, don’t sit back and suffer. Consult with your doctor about the right treatment for you.

Source: MSN Health

SOURCE: Reglan Side Effects › Reglan may stop hiccups, but may cause more serious problems

Dr. David Carroll of Surgical Specialists of Jackson, Miss., offers a completely noninvasive procedure to treat GERD that requires no injection, cutting or penetration of the skin. It is called transoral incisionless fundoplication (TIF) surgery with the EsophyX device. Dr. Carroll says he has performed the procedure many times laparoscopically over the past 15 years, but the new EsophyX device allows him to perform the surgery using an endoscope inserted through the patients’ mouths.

“It developed over the last several years. The results are really good,” Dr. Carroll told the Clarion Ledger. He performed the first TIF with the EsophyX in Mississippi on 46-year-old Connie Braswell of Pearl, Miss. Braswell had treated her GERD symptoms for years with Nexium, but last year her symptoms worsened. “It got to the point where I was burping every day, all day long. It was very irritating,” she says.

Two gasterenterologists and two general practitioners tried her on various medications, including Reglan (metoclopramide), but nothing worked. She began restricting her diet, giving up dairy products, spicy food, coffee, and her beloved Dr. Pepper. She shed 28 pounds in the process, but she wasn’t happy. She missed the foods she used to enjoy.

Then Dr. Carroll told her about the new, noninvasive procedure using the EsophyX device, and it changed her life. “I prayed and prayed to get better and nothing else worked,” she says. “and this is working.”

Pictured are Dr. David Carroll, Dr. Jeffrey Glover and Dr. David Miller of Surgical Specialists of Jackson.

SOURCE: Reglan Side Effects › Non-surgical procedure offers hope to patients with GERD

Gastroparesis is a serious condition in which food takes too long to move through the stomach. It can result in pain and disability as well as poor nutrition. Those who suffer are usually treated with medication. But sometimes the medication does not work or can cause serious side effects.

One such treatment is metoclopramide, known in the U.S. by the brand name Reglan. While it can provide relief to some patients, long-term use of metoclopramide has been linked to a serious movement disorder known as Tardive Dyskinesia. Those who suffer from the condition have involuntary movements of their muscles which can include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers.

Medication wasn’t working for Munshi, but she found relief through the Internet in another from, a gastric pacemaker that is implanted in the stomach that shocks the stomach muscles to contract. After surgery, Munshi says doctors gave her tomato soup, but the patient felt so much better that when she got home she devoured her favorite dish – saag aloo. “Everything tastes great now and I haven’t been sick since,” she says.

Sources:
The Metro
The Sun

SOURCE: Reglan Side Effects › Pacemaker gives hope to sufferer of gastroparesis

Patients who suffer from regular vomiting, stomach pain or trouble swallowing are usually given diagnostic tests such as endoscopies, biopsies and CT scans. Some patients are sent to other cities for more advanced testing. With the opening of El Paso’s new clinic, patients who suffer from serious gastrointestinal conditions have more options for specialized care.

“Rather than sending patients to the Mayo Clinic, we can take care of them right here,” says Dr. Richard McCallum, a gastroenterologist and chairman of the Department of Internal Medicine at El Paso’s medical school, in an interview with the El Paso Times. “We offer a very cutting-edge array of the best tests to diagnose the disorders.”

These tests include an esophageal motility test to measure the muscles and pressure of the esophagus; and a gastric emptying test and an ingestible SmartPill, both of which monitor how quickly food leaves the stomach. “These are a series of tests the average hospital and (doctor’s) office do not have,” Dr. McCallum says.

The center will also conduct medical students for new drugs and treatments for various gastrointestinal conditions, including gastroparesis, a condition in which the stomach empties its contents too slowly causing pain, disability and nutritional problems for those who suffer from the condition.

SOURCE: Reglan Side Effects › New medical center to focus on gastrointestinal disorders

Salix Pharmaceuticals’

Marketing for Metozolv was approved last September by the Food and Drug Administration (FDA) for the treatment of short-term therapy (4-12 weeks) for adults with symptomatic documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy. It also is the first orally disintegrating tablet formulation for both acute and recurrent diabetic gastroparesis.

“We are very proud to achieve the FDA approval of Metozolv ODT,” said Eugene T. Haley, CEO of Wilmington Pharmaceuticals, developers of Metozolv. “We’re especially pleased that the application of Catalent’s Zydis technology to this proven medication may enhance the lives of patients for years to come. Metozolv’s success further validates the commercial attractiveness of fast-dissolving dosage forms and illustrates the significant inherent value in bringing together a game-changing drug delivery technology with product development expertise and a top notch sales and marketing organization.”

While approved by the FDA, Metozolv carries the same black box warning as other metoclopramide products, such as Reglan. The medication fell under the warning earlier this year after numerous reports of a serious movement disorder known as Tardive Dyskinesia were linked to long-term use of metoclopramide.

Source: Reuters

SOURCE: Reglan Side Effects › New GERD, gastroparesis treatment uses fast-dissolve technology

Click here to view the embedded video.

YouTube user Video2fone1, who posted the video of 25-year-old Desiree Jennings, says, “Experts claim serious side effects of flu shots amount to about one in a million. Well, here is what that one in a million looks like.”

Jennings, who was training to be a professional football cheerleader, got a flu shot in August. Ten days later she began suffering from dystonia. Now she cannot walk or talk without difficulty. Oddly, she can run seemingly normally. While running she can talk normally, too. She can even walk backwards without the excessive movements. But when she stops or begins to move forward, the jerking movements come back.

Reactions to the flu shot like Jennings’ is rare, but the risk of developing a type of dystonia is greater with some medications. For example, the Food and Drug Administration earlier this year issued a black box warning on Reglan after reports of patients who took the medication began suffering from a type of dystonia known as Tardive Dyskinesia. Up to 20 percent of consumers who took Reglan for more than 12 weeks contracted the disorder. Now the drug’s label warns users against long-term use, but the warnings come too late for too many who are suffering just like Jennings.

SOURCE: Reglan Side Effects › Woman suffers from movement disorder after getting flu shot

Elizabeth Conte

More and more cases of consumers taking metoclopramide and subsequently developing Tardive Dyskinesia were reported to the Food and Drug Administration (FDA), and by early 2009, the agency had ordered a black box warning be placed on the medication. New warnings and precautions were written into the drug’s packaging that included an up to 20 percent risk of patients developing Tardive Dyskinesia during long-term use of the medication.

But the warnings came too late for Conte, and for her doctor, who she alleges was unaware of the risks because Reglan’s maker, Wyeth, disseminated misleading and/or incomplete warnings about the drug’s side effects. She sued Wyeth, claiming the company knew of a widespread tendency among physicians to mis-prescribe Reglan and generic metoclopramide for long periods of time even though the medication is only approved for 12 months of use. The drug’s labeling, her lawsuit claimed, substantially understated the risks of serious side effects from extended use.

Initially, the trial court ruled in favor of Wyeth, which argued that it was the physician’s duty to warn patients of any ill effects drugs may have on patients. Conte appealed, arguing the drug’s manufacturer should be responsible. The Court of Appeal concluded that Wyeth was obligated to disseminate accurate product warning labels.

Source: Sierra Sun

SOURCE: Reglan Side Effects › Women suffering from movement disorder sues Reglan maker Wyeth

The study, conducted by researchers from Copenhagen University, involved 120 healthy participants who took either an inactive placebo or 40 mg of the PPI drugs daily for three months. Each patient filled out a Gastrointestinal Symptom Rating Scale weekly to gauge symptoms. Researchers found that a greater percentage of people taking the PPI experienced at least one worrisome acid-related symptom during the treatment than those taking a placebo.

“We find it highly likely that the symptoms observed in this trial are caused by rebound acid hypersecretion and that this phenomenon is equally relevant in patients treated long term with PPIs. If rebound acid hypersecretion induces acid-related symptoms, this might lead to PPI dependency. Our results justify the speculation that PPI dependency could be one of the explanations for the rapidly and continuously increasing use of PPIs,” said Dr. Christian Reimer, the study’s lead author.

These findings show that safe treatment options for people suffering from GERD are limited. Earlier this year, Reglan (metoclopramide), another treatment for the condition, received a black box warning from the Food and Drug Administration (FDA) after numerous reports that people taking Reglan began to suffer suffer from a serious, involuntary movement disorder known as Tardive Dyskinesia. The black box warning advises that the medication not be taken for more than 12 weeks as the risk of contracting the disorder increases to about 20 percent among those taking the drug long term.

Experts advise suffers of GERD should consult with their physicians to find the safest treatment options.

SOURCE: Reglan Side Effects › Heartburn, GERD treatments linked to serious complications

According to researchers at the Feinstein Institute, there are two separate pathways in the brain that influence the severity of the symptoms of movement disorders. All individuals who carry the mutations and symptoms for dystonia have an abnormal pathway between the cerebellum and the thalamus. These patients also have a normal second pathway between the thalamus and the cortex. However, researchers found that patients who have the mutation in the first pathway as well as in the second pathway have no symptoms of dystonia. In effect, the two defects seem to cancel each other out.

Researchers say this could be promising news to individuals who suffer from various movement disorders, from Parkinson’s disease to Tardive Dyskinesia, a condition that results from long term use of medications such as metoclopramide, a treatment for GERD and gastroparesis, and antidepressants.

One surgical treatment for both that has shown promising improvements in motor symptoms is known as deep brain stimulation, or DBS. Which leads researchers to ask, does abnormal brain wiring improve dystonia the same way as DBS?

Source: Brain Blogger

SOURCE: Reglan Side Effects › Brain mutation may prevent movement disorders

Last month, the FDA issued a black box warning on the injectable form of promethazine hydrochloride. Promethazine hydrochloride, once sold under the now-discontinued brand name Phenergan, is available in generic formulations in the form of tablets, liquid, rectal suppository, intravenous injection and intramuscular injection. The black box warning cautions health care providers against administering the IV injection into an artery or under the skin because gangrene or other severe tissue injury can result. It also can leach out from the vein during IV administration, causing serious tissue damage.

Another anti-nausea medication is metoclopramide, known by the brand names Reglan and Metozolov. The drug can be administered by injection, or taken as a pill by mouth. Metoclopramide is also a treatment for gastrointestinal conditions such as gastroparesis and GERD. Earlier this year, an FDA black box warning was placed on metoclopramide after long-term use of the drug was linked to a serious and debilitating involuntary movement disorder known as Tardive Dyskinesia.

Tardive Dyskinesia is identified by involuntary head jerking, eye blinking, facial grimacing, pucker and pursing of the lips, lip smacking and tongue thrusting. It may also involve involuntary movements of the fingers and hands. There is no known cure for Tardive Dyskinesia, even after the medication has been discontinued.

SOURCE: Reglan Side Effects › Anti-nausea drugs carry black box warnings

Metoclopramide

This is promising news, considering there are no FDA-approved drugs to treat morning sickness, and drugs once thought safe for unborn babies, such as Thalidomide and Bendectin, were later linked to serious birth defects such as limb deformities.

Critics argue that there is not enough good-quality evidence that metoclopramide is safe for pregnant women or that it is effective in curtailing nausea and vomiting. One study of 40 women found that steroids worked better than metoclopramide for women, resulting in fewer times a woman vomited and eliminating the need for hospitalization.

Another concern about metoclopramide is the black box warning that is now on the drugs. The new labeling warns patients treated with metoclopramide of the risk of developing a serious and debilitating involuntary movement disorder known as Tardive Dyskinesia. The symptoms, which include jerking, facial twitches and involuntary movements of the hands and tongue, often do not go away after treatment is discontinued.

The risk of Tardive Dyskinesia is even greater for patients who take the metoclopramide for 12 weeks or longer, with some studies showing as many as 20 percent of long-term users developing the condition.

Serious morning sickness can cause problems for both the mother and her unborn child, which is why women who suffer from morning sickness should thoroughly discuss their treatment options with their physician to better understand the benefits and risks.

SOURCE: Reglan Side Effects › Pregnant women should weigh risks of morning sickness medications

Medications most often associated with Tardive Dyskinesia include metoclopramide, known in the U.S. by the brand names Reglan and Metozolv, and psychiatric drugs Thorazine, Stelazine, Haldol, Prolixin, Zyprexa, Risperdal and Clozaril.

While nothing seems to cure the condition, some treatments have been shown to bring relief to sufferers. Those treatments include:

- Vitamin E may have some beneficial effects on patients, especially those who have not yet developed Tardive Dyskinesia. Since large doses of vitamin E can be toxic, it is recommended that patients consult with their doctors before adding supplemental vitamin E to their diets.
- Botulinum toxin injections (BTX), also known as BOTOX therapy, has been shown to relieve symptoms that involved limited groups of muscles. Consult with your doctor to see if this form of treatment is right for you.
- Some medications have been used to successfully treat Tardive Dyskinesia. Talk with your doctor about options in drug therapy.

If you suffer from Tardive Dyskinesia, or are experiencing any unusual and involuntary movements, and take or have taken metoclopramide or any psychiatric drugs, you are encouraged to seek specialized medical treatment.

Source: National Empowerment Center

SOURCE: Reglan Side Effects › Treatments available for drug-induced Tardive Dyskinesia

Tardive Dyskinesia and Tardive Dystonia are serious movement disorders caused by psychiatric medications. Earlier this year, the Food and Drug Administration (FDA) issued a black box warning to patients and health care providers that patients taking metoclopramide, a drug to treat heartburn, GERD and other gastrointestinal conditions, were at greater risk of developing Tardive Dyskinesia. Patients who used metoclopramide for 12 weeks or longer were at an even greater risk of developing the condition. Some studies show as many as 20 percent of patients who used metoclopramide long-term developed the disorder.

Metoclopramide is known in the U.S. by the brand name Reglan. A orally dissolving table form of metoclopramide, Metozolv, has just been approved by the FDA and carries the same black box warning for Tardive Dyskinesia.

Tardive Dyskinesia expresses itself in various ways, including involuntary lip smacking; blinking; raising eyebrows; tongue twitching and protrusion; toe tapping; and jerking; and repetitive, involuntary motions of the fingers, hands, arms, legs and/or torso. Sometimes movements are slight and barley noticeable. For others, the movements are debilitating and sometimes painful. The movements usually cease during sleep but are more pronounced when the sufferer is anxious or under stress.

There have been successful lawsuits filed by individuals diagnosed with Tardive Dyskinesia that has been caused by their medication, including one in which a jury awarded the plaintiff $1.3 million. If you have suffered from involuntary movements following use of metoclopramide or any other medication, you may have a claim against the drug maker.

SOURCE: Reglan Side Effects › Few resources available for those with Tardive Dyskinesia

Metoclopramide is most commonly known in the U.S. by the brand name Reglan, made by Schwarz Pharma. Salix Pharmaceuticals also just received FDA approval to market in the U.S. an orally disintegrating metoclopramide tablet by the name of Metozolv. Metoclopramide is also sold in other countries under the brands Maxolon, by Shire/Valeant, Degan by Lek, Maxeran and Primperan by Sanofi Aventis, and Pylomid by Bosnalijek.

The medication is primarily used to facilitate gastric emptying in patients with gastroparesis, and in the treatment of severe GERD. It also is used to treat nausea and vomiting, morning sickness, migraine headaches, and has been shown to stimulate lactation in nursing women.

Because metoclopramide is a dopamine antagonist, it may worsen the symptoms of Parkinson’s disease. It is also contraindicated for patients with a suspected bowel obstruction and those who suffer from clinical depression, as it may aggravate symptoms of depression. But long-term use, which is necessary in some patients, especially those suffering from gastroparesis, has been shown to cause the Parkinson’s-like symptoms of Tardive Dyskinesia among otherwise healthy people. Because of the new black box warning issued by the FDA, labeling for metoclopramide medications now carry a warning of Tardive Dyskinesia. Unfortunately, the warning is too late for many who know find themselves with a diminished quality of life from a medication that was to designed to improve their quality of life.

SOURCE: Reglan Side Effects › Metoclopramide can diminish quality of life

Torax Medical, Inc.,

The LINX is a device made up of a string of tiny magnetic beads encased in titanium. During laparoscopic surgery, the beads are placed on the lower end of the esophagus, forming a ring around the lower esophageal sphincter (LES). The force of the magnets pulls each bead closer to those on each side, like a rubber band, preventing stomach acid from refluxing into the esophagus, causing heartburn. Ideally, patients able to stop medications and eat a normal diet by the time they are released from the hospital on the day after surgery.

However, the procedure is not without risks. The beads can migrate from their intended location and need to be removed or replaced. And if the string of beads is not wrapped tightly enough or is wrapped too tightly, it may not work properly. But if it does work effectively, it will offer an alternative to medication for suffers of GERD. Medication that in some cases can cause serious problems for the users.

One of the most common prescriptions for patients with GERD is metoclopramide, known by the brand name Reglan. Earlier this year the Food and Drug Administration (FDA) issued a black box warning on metoclopramide after numerous reports of a serious movement disordered called Tardive Dyskinesia was linked to the use of the drug, in particular the long-term use of metoclopramide. The condition is debilitating and can continue even after the medication has been stopped. Because long-term use of Reglan is now discouraged, patients are hopeful that new treatments will make GERD more manageable.

SOURCE: Reglan Side Effects › New GERD treatment may spell relief for sufferers

What Brittney wants people to understand is what being sick with a chronic illness means. Sure, the condition has left her with a slim figure which has earned her compliments in this society where “skinny” is “in.” But she is far from lucky, she says. “It drives me insane.”

It is unlikely her condition will improve. And people who suffer from gastroparesis have few treatment options. Some people can manage their condition with diet. Others must rely on medication or surgery. But there are risks to surgery, and even the medication raises concerns.

One popular medication for gastroparesis is metoclopramide, known by the brand name Reglan. Earlier this year the Food and Drug Administration (FDA) issued a black box warning on the drug after it was linked to a serious movement disorder known as Tardive Dyskinesia. The debilitating condition often doesn’t go away even after treatment has stopped.

There are several other illnesses besides gastroparesis that fall under the “invisible illness” umbrella, such as Fibromyalgia and scleroderma. For Brittney, raising awareness for such conditions brings her hope that better treatments will be found and she will be able to lead a more normal life. For activities and forums as part of Invisible Illness Week, go to InvisibleIllnessWeek.com.

Source: Journal Star

SOURCE: Reglan Side Effects › Sufferers of chronic conditions raise awareness for invisible Illness week

GERD “disrupts sleep, causes insomnia, and is associated with daytime impairment,” says Dr. Susan M. Harding with the University of Alabama at Birmingham, and may lead sufferers to seek treatment for sleep issues rather than for the condition that is causing the sleep disturbance.

The problem, says Dr. Anthony J. DiMario Jr., who leads a research study on the subject at Thomas Jefferson University, widely prescribed Ambien (zolpidem), which works to suppress nocturnal arousals to aide in restorative sleep, also helps people sleep through their symptoms of GERD. Those who sleep through their symptoms may forgo treatment to stop the symptoms and thus may suffer even worse complications.

GERD can be treated through lifestyle changes, such as raising the head of the bed so that the sufferer doesn’t sleep flat, eating smaller meals, and avoiding foods that promote reflux, such as chocolate, peppermint, alcohol and caffeinated drinks. Some medications, both prescription and OTC, are used to treat the condition, but some carry risks.

Reglan (metoclopramide) is a prescription medication approved in the treatment of GERD. A pro-motility drug that works by stimulating the muscles of the gastrointestingal tract including the esophagus, stomach, small intestines and colon, metoclopramide has been associated with a serious movement disorder known as Tardive Dyskinesia. The condition is debilitating and can continue even after treatment has been stopped.

Sources:
Science Daily
Reuters Health Stories

SOURCE: Reglan Side Effects › Sleep aids may hinder detection of nighttime GERD

The Gastroparesis, etc… blogger was diagnosed with the condition in 2004, and in that time has gathered a great deal of information on treatments for the debilitating condition, which she readily shares on her Web site. Gastroparesis is individualized and a treatment that works for one person may not work for another, she says.

She has tried a long list of treatments from Botox to acupuncture to Reglan, but few have worked well for her. She will receive a gastric neurostimulator, also known as a gastric pacemaker, next week. “It took four months to get the procedure approved by my insurance company, but in that time I gained a great deal of knowledge and collected a plethora of resources which I am anxious to pass along.”

The blogger also passes on to her readers information about new treatments and drug warnings, such as the recent black box warning on metoclopramide, also known by the brand name Reglan, and the newly approved Metozolv ODT, an orally disintegrating version of the same medicine. The black box warning notifies patients and health care workers of an increased risk of a serious movement disorder known as Tardive Dyskinesia associated with long term use of metoclopramide.

Whatever course of treatment sufferers of gastroparesis choose, the blogger offers this advice: “Be your own advocate. Truly, in every way. Do your own research. Try everything for yourself. And never, ever give up!”

SOURCE: Reglan Side Effects › Gastroparesis sufferer urges, Never give up!

Gastroparesis is unpredictable – there are good days and bad, making it hard to manage. There is often no explanation for a drastic change in symptoms from one moment to the next. Because sufferers often do not look sick, gastroparesis, called a “silent illness,” is often disregarded by those who don’t understand it.

G-PACT, www.g-pact.org, is an organization that was founded in 2001 to help increase awareness of gastroparesis and another serious gastrointestinal motility disorder, chronic intestinal pseudo-obstruction (CIP), in an effort to seek funding for better research into the causes of and treatment for the disorder. The site also gives sufferers a community where they can share personal stories and triumphs.

G-PACT aims to help find more options for suffers of serious GI motility disorders. “These conditions are not just inconveniences. They are disabling, and in some instances, can even be fatal,” according to the Web site. “There are few treatment options available, and even those have complications and limited effectiveness. Little attention has been given to these illnesses for research due to lack of awareness of the need.”

One of the few treatments available for gastroparesis is metoclopramide, sold in the U.S. under the brand name Reglan. Earlier this year, the Food and Drug Administration (FDA) issued a black box warning on the drug after numerous reports of a serious movement disorder known as Tardive Dyskinesia were associated with the long term use of Reglan.

According to the organization’s Web site, “GI motility disorders are under-recognized, so therefore ignored by many medical companies, pharmaceutical companies, and the FDA.”

SOURCE: Reglan Side Effects › Organization raises awareness, funding for GI motility disorders

Reglan was first approved by the Food and Drug Administration in 1980 to treat GERD and gastroparesis, or delayed stomach emptying. According to The People’s Pharmacy, “Although doctors were warned early on that this drug could cause a neurological disorder, it took the Food and Drug Administration almost 40 years to issue a black box warning about this complication.”

That warning of an increased risk of Tardive Dyskinesia with long-term use of Reglan was issued on February 26, 2009, and the makers of Reglan were ordered to add it to the medication’s labeling. The condition is characterized by involuntary repetitive movements of the extremities, lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. Even after medication has been discontinued, symptoms may still persist.

More than 2 million Americans use some form of Reglan, and as many as 20 percent suffer from Tardive Dyskinesia. If you or a loved one have suffered from side effects of Reglan, you may have a claim against the manufacturer.

* names have been changed.

SOURCE: Reglan Side Effects › Long term use of Reglan linked to serious movement disorder

Salix Pharmaceuticals, Ltd

Gastroparesis, or delayed emptying of the stomach contents, affects nearly 1.5 million people and can cause pain, bloating, vomiting and malnutrition. GERD, or gastroesophageal reflux disease, affects approximately one-third of the U.S. population. Metozolv ODT is designed for sufferers of both conditions who have difficulty swallowing, need treatment but do not have water available, or need a portable way to take medication. Metozolv ODT rapidly melts on the tongue and gives patients an alternative to the pill form of metoclopramide.

Metozolv ODT will carry the same black box warning as the brand name metoclopramide, Reglan, which warns users that long-term therapy (12 weeks or longer) increases one’s risk of a serious involuntary movement disorder known as Tardive Dyskinesia. The condition is disabling and does not usually go away once treatment with metoclopramide has stopped.

Metozolov ODT packaging will also warns users that the drug should be used with caution in patients showing acute dystonic reactions, drug-induced Parkinsonism, or other extrapyramidal symptoms, and neuroleptic malignant syndrome with a prior history of depression.

Last week, in anticipation of the FDA’s approval, Salix announced that it will increase its sales force by 60 percent to help market Metozolov ODT. The drug has patent protection until 2017, and additional patent protection pending that, if issued, could provide patent protection until 2025.

Source: Reuters

SOURCE: Reglan Side Effects › Salix receives FDA approval to market new metoclopramide drug

Salix Pharmaceuticals

Salix hopes to gain full FDA approval to market Metozolv as a short-term therapy (4-12 weeks) for adults with symptomatic, documented gastroesophageal reflux (GERD or heartburn) who fail to respond to conventional therapy, and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis, or delayed emptying of the stomach. Salix currently has 96 salespeople and wants to hire and additional 64 people to its sales force this year to help push the new product.

Drugs for such gastrointestinal ailments as gastroparesis are few and far between and not without their issues. It remains to be seen if when Metozolv hits the market, it will carry the same black box warning already on Reglan, an oral tablet form of metoclopramide that is swallowed. The boxed warning came after it was revealed that long-term use of the drug was linked to a serious involuntary movement disorder known as Tardive Dyskinesia. There is no known cure for the condition, and symptoms may persist even after the medication has been discontinued.

Source: The News & Observer

SOURCE: Reglan Side Effects › Salix plans to increase sales force to push new gastroparesis drug

Scleroderma is a chronic and disabling connective tissue disorder that involves changes in the skin, blood vessels, muscles and internal organs. For most, the condition is progressive. If the gastrointestinal tract, heart, kidneys or lungs are involved, the condition can be fatal. Secondary conditions resulting from scleroderma include gastroparesis and pulmonary hypertension.

The Scleroderma Research and Awareness Act, co-sponsored by Senator Charles Schumer (D-NY) gives hope to the 300,000 Americans and their families living with this disease. The legislation specifies:

1. Directing the National Institute of Arthritis and Musculoskeletal and Skin Diseases at the National Institutes of Health to expand research related to scleroderma. Priority areas would include:

• Development and evaluation of new treatments.
• Research on the relationship between scleroderma and secondary conditions including: pulmonary hypertension, gastroparesis, Raynaud’s phenomenon, and Sjogren’s syndrome.
• Establishment of family and “childhood-onset” patient registries.
• Support for the training of new investigators.

2. Directing the Centers for Disease Control and Prevention to establish a scleroderma public awareness campaign highlighting disease symptoms, prevalence, related conditions, and the importance of early diagnosis.

Treatment for scleroderma includes corticosteroids, immunosuppressants and NSAIDs. Other treatments for specific symptoms, such as heartburn and gastroparesis, include antacids or Reglan (metoclopramide), medicines to improve breathing, and blood pressure medications.

SOURCE: Reglan Side Effects › Scleroderma bill will raise awareness, fund research

Gastroparesis can cause symptoms such as abdominal pain, nausea, early fullness while eating meals and heartburn and can lead to weight loss and poor absorption of nutrients. Some studies have shown that women are as much as seven times more likely to suffer from gastroparesis than men, but the reason is unknown. It is also suspected that more people actually suffer from the condition because symptoms may overlap with other conditions such as irritable bowel syndrome and GERD.

Some people can manage their symptoms with diet or medication, while others may suffer so severely they may require hospitalization. Patients are usually instructed to avoid high-fiber foods, and others may require switching to a liquid diet to maintain hydration. Medication offers only temporary relief at best. For example, long term use of a popular treatment for gastroparesis, Reglan (metoclopramide), can result in a serious involuntary movement disorder called Tardive Dyskinesia.

The best defense to keep symptoms at bay, says Dr. Linda Lee, board certified in internal medicine and gastroenterology and director of the Johns Hopkins Integrative Medicine and Digestive Center, is following a low-fiber diet, taking medications in moderation, and addressing anxiety and depression, which can exacerbate symptoms.

SOURCE: Reglan Side Effects › Women more likely than men to suffer from gastroparesis

Gastroparesis is a digestive disorder in which the stomach takes too long to empty its contents. Literally, gastroparesis means “stomach paralysis,” and those who suffer from the condition can suffer a host of conditions including bloating, nausea, early fullness while eating meals, heartburn, and epigastric pain. Weight loss and poor absorption of nutrients are also serious are other serious outcomes of the disease.

Only a few medications are available to treat gastroparesis, including metoclopramide, domperidone, erythomycin and cisapride.

Metocloparmide, known in the U.S. by the brand name Reglan, works to stimulate stomach contraction. Reglan, however, has been linked to a serious and debilitating involuntary movement disorder called Tardive Dyskinesia, and now carries a black box warning.

Domperidone is similar to metoclopramide but does not carry the same risk of Tardive Dyskinesia. Domperidone is available in Mexico, Canada and some European countries but is not yet available in the U.S.

Erythomycin is a common antibiotic that works to stimulate receptors in the intestines and stomach. Most patients have a high likelihood of developing tolerance to the medication.

Cisapride is a medication that binds to serotonin receptors in the stomach wall and encourages the contraction of the stomach muscles. In the late 1990s, the medication was taken off the market because of complications of cardiac arrhythmia in patients who used the drug. The drug is back on the market for limited use and is not recommended for people with underlying kidney or heart disease.

An emerging therapy is showing promise for people who suffer from gastroparesis. Octreotide, a medication used to treat diarrhea, has been shown in a study among patients with scleroderma to speed up the emptying of stomach contents. Another study indicated the medication decreased the uncomfortable sensation of fullness following a meal. While the studies look promising, researchers say more studies are needed to determine if octreotide is a viable option for patients with gastroparesis.

Source: American College of Gastroenterology

SOURCE: Reglan Side Effects › Gastroparesis treatments offer little relief

The condition in which the stomach takes too long to empty its contents, most often is caused by diabetes but has been associated with infections, endocrine disorders, connective tissue disorders such as scleroderma, autoimmune conditions, neuromuscular diseases, cancer, radiation treatments applied to the chest or abdomen, some forms of chemotherapy, and surgery of the upper intestinal tract. People with eating disorders such as anorexia or bulimia may also develop gastroparesis.

Those with gastroparesis suffer from a host of symptoms such as discomfort of feeling too full too soon after eating a meal, heartburn, nausea and vomiting. Poorly digested food also can collect in the stomach and form a bezoar, a mass of undigested matter that may cause a blockage that can prevent the stomach from emptying, resulting in pain and nausea. The bothersome symptoms of gastroparesis can result in weight loss and poor absorption of nutrients, which makes diet and nutrition of the utmost importance to those with the condition.

Few medications are available for people with the condition, and most carry serious side effects. For example, Reglan (metocloparmide) was recently linked to a serious involuntary movement disorder known as Tardive Dyskinesia. The medication now carries a black box warning. Such warnings leave many searching for better ways to control their gastroparesis.

Some foods are more difficult for the stomach to digest, such as fatty or fibrous foods such as raw vegetables. People with gastroparesis should reduce their intake of fibrous foods or eliminate fiber from their diet altogether. If one chose to eat foods high in fiber, he should be sure to chew the food well and cook it until tender. If necessary, solid food can be pureed in a blender to ease digestion.

Thick and thin fluids such as puddings and nutritional drinks tend to pass well through the digestive tracts of those with the condition. Supplemental nutrition drinks are among the best choices for those with gastroparesis because they can provide important nutrients for the body that one may not be able to get with such a limited diet.

Source, American College of Gastroenterology

SOURCE: Reglan Side Effects › Diet, nutrition key for people with gastroparesis

The patient suffers fro gastroparesis, a condition in which the stomach empties its contents too slowly. It often affects people with diabetes. However, in as many as 60 percent of children with the condition, the cause is unknown.

The procedure involves inserting the pacemaker into the abdomen and placing the electrical wires attached to the device on the stomach. Electrical impulses stimulate the stomach after eating, encouraging the stomach to empty its contents.

“The initial settings are fairly low and, as with a pacemaker in the heart, we can change the settings as needed,” said pediatric surgeon Steven Teich, MD, surgical director of the Bariatric Surgery Program at Nationwide Children’s Hospital and clinical assistant professor of surgery at The Ohio State University College of Medicine.

Pacemakers have been used to treat gastroparesis in adults and results have been promising. “In patients who have received this type of treatment, nearly all symptoms were resolved within two weeks,” said said pediatric gastroenterologist Hayat Mousa, MD, medical director of the Motility Center at Nationwide Children’s Hospital and Associate Professor of Clinical Pediatrics at The Ohio State University College of Medicine.

The procedure takes the place of other, less effective treatments, commonly the medication metoclopramide known in the U.S. by the brand name Reglan. Reglan can only be used for short terms, as long-term use has been linked to a serious and debilitating involuntary movement disorder known as Tardive Dyskinesia. Earlier this year, the Food and Drug Administration (FDA) placed a black box warning on the medication alerting patients and health care professionals of the serious risk when using the medication for more than 12 weeks.

Other medications used to treat gastroparesis include antibiotics, which also carry a list of side effects. “None of these options are really that effective. Hence, the need for better treatment with the gastric pacemaker,” says Dr. DiLorenzo, Chief of Gastroenterology at Nationwide Children’s Hospital.

Source: DotMed News

SOURCE: Reglan Side Effects › Procedure shows promise versus drugs for children with gastroparesis

Gastroparesis is a disorder in which the stomach takes too long to empty its contents. It is the result of damage to the vagus nerve, which controls the movement of food through the digestive system. The most common cause of gastroparesis is diabetes, though it may also be caused by viral infections, eating disorders such as anorexia nervosa or bulimia, nervous system diseases such as Parkinson’s disease, gastroesophageal reflux disease, and certain metabolic disorders. In some cases, the cause is unknown.

An estimated 10 million people suffer from gastroparesis. Patients are often prescribed metoclopramide, a drug known in the U.S. by the brand name Reglan, to treat their condition. Recently, the Food and Drug Administration (FDA) issued a black box warning on metoclopramide/Reglan after an investigation found that patients who took the drug were at an increased risk of developing a severe involuntary movement disorder known as Tardive Dyskinesia. People treated with metoclopramide/Reglan for more than 12 weeks are at greater risk. The condition is often irreversible, even after the medication has been stopped.

With so few treatment options available to gastroparesis sufferers, the Gastroparesis Awareness Campaign Organization is using this month to push for funding to help find new medications to treat the millions of people who suffer from gastroparesis. “We will be having additional fund raisers this year as well sending out care packets to help bring smiles to those suffering with gastroparesis,” states the organization’s Web site. “Together, we will fight for a cure!”

SOURCE: Reglan Side Effects › August is Gastroparesis Awareness Month

Tranzyme Pharma’s

TZP-102 is an oral medication. Tranzyme’s equivalent medication, TZP-101, a drug given by IV in a hospital setting, has been put on hold by the company. While the drug showed promising results in phase II trials, the company hopes to buy time until the markets improve and the cost of capital drops.

Diabetic gastroparesis is a disorder in which the stomach takes too long to empty its contents. It affects people with both type 1 and type 2 diabetes. The condition is often treated with metoclopramide, sold in the U.S. under the brand name Reglan. Earlier this year, the FDA required manufacturers of metoclopramide to put a black box warning on the  medication warning health care providers and consumers of the risk of a serious involuntary movement disorder known as Tardive Dyskinesia.

Patients who suffer from Tardive Dyskinesia experience such as lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, pucker and pursing of the lips and involuntary movements of the fingers. The condition is often irreversible even after medication has been stopped.

Analysts say a new treatment for diabetic gastroparesis would be welcome in an area where few treatments are currently available.

Source: Biz Journals

SOURCE: Reglan Side Effects › New treatment for gastroparesis granted FDA ‘fast-track’ status

Earlier this year the Food and Drug Administration (FDA) issued a black box warning on Reglan to warn of the increased risk of the movement condition known as Tardive Dyskinesia. The condition is more pronounced in individuals who take the medication for more than 12 weeks. Tardive Dyskinesia is identified by involuntary movements of the muscles that include eye blinking and bulging, head jerking, lip smacking, tongue thrusting, facial grimacing, puckering and pursing of the lips and involuntary movements of the fingers.

The condition may be permanent even after the medication has been stopped. The medication also may mask the symptoms of the condition, which often get worse after the drug is discontinued.

While the elderly are most at risk, children, like Joey, can suffer serious side effects as well. “My son has been through a lot. He has had problems at school and has had a lot of other children asking him why do you blink your eyes and jerk your head. He has been to many doctors and put on several types of medicines. He has also been diagnosed with severe anxiety, which is also a side effect of this drug,” his mother says. “I would advise anyone taking this drug to stop immediately! The side effects are permanent and are very life altering. This drug is dangerous and the FDA needs made responsible for all the sufferers out there. Don’t let the FDA fool you…they have known about these symptoms since 1984…I have done my research!”

* names have been changed

SOURCE: Reglan Side Effects › Reglan side effects leave young boy with serious movement disorder

Earlier this year the FDA placed a black box warning – the sternest warning it can require –on Reglan after reports of users of Reglan began suffering from a serious and debilitating involuntary movement disorder known as Tardive Dyskinesia. Those who suffer from the condition develop involuntary movements of the muscles, such as lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers.

Those who take Reglan for more than 12 weeks are at greater risk of developing Tardive Dyskinesia, thus the new labeling advises against long-term use except in rare cases where the benefit outweighs the risks.

Given the black box warning now on Reglan, sufferers of digestive problems may want to turn to old-fashioned, natural alternatives. For example, ginger root aides in digestion and licorice root soothes mucous membranes along the GI tract. Peppermint settles the stomach and aides in the production of saliva. And Rubarb works to rid excessive mucous in the intestines.

For more information, visit your local health food store. And always be sure to discuss any medication or diet changes with your health care provider.

Source: Examiner

SOURCE: Reglan Side Effects › Reglan users may want to consider natural remedies

The watchdog group sifted through assessments based on reviews of published data from medical journals and unpublished data from the USA, and has cataloged 136 commonly prescribed drugs that can produce symptoms of dementia or delirium. Dementia is a memory disorder. Delirium involves sudden changes to vision, hearing and thinking. Reports show that in many cases, doctors overlook the possibility that a patient’s medications may be causing his dementia or delirium.

The elderly are at greater risk of adverse events from medications, possibly due to a build-up in higher doses of medication in their bodies due to decreased kidney or liver function. Older adults also may take multiple drugs that could interact and produce unusual side effects. Furthermore, those suffering from a cognitive impairment are more likely to have their problem worsened by medications. Their symptoms also may be overlooked by physicians as symptoms of aging.

One such adverse event is a serious involuntary movement disorder, much like Parkinson’s disease, called Tardive Dyskinesia. The condition has been linked to long-term use of Reglan (metoclopramide) as well as some antidepressants. The elderly are especially susceptible to Tardive Dyskinesia.

Source: Natural News

SOURCE: Reglan Side Effects › Watchdog group catalogs 136 meds that can cause dementia, delirium

Metoclopramide accelerates food absorption and may slow the emptying of solids, thus diabetics may need to increase insulin doses. The drug also may reduce the absorption of medications, such as the heart medication digoxin. The drug also has been linked to a serious movement disorder known as Tardive Dyskinesia. Concurrent use of phenothiazine and butyrophenone tranqulizers should be avoided because they increase the potential for Tardive Dyskinesia. The condition causes involuntary muscle spasms, motor restlessness and inappropriate aggression.

Earlier this year the Food and Drug Administratin (FDA) issued a black box warning on Reglan (metoclopramide) for the risk of Tardive Dyskinesia with long-term use of the medication. The elderly are at higher risk of experiencing side effects, in particular Tardive Dyskinesia. Dosage may need to be adjusted in older patients with impaired kidney function. Children may experience muscles spasms and Tardive Dyskinesia as well as blood problems if they take high doses of the medication.

Individuals who have suffered side effects after taking Reglan (metoclopramide) should contact their physicians. They may also have a lawsuit against the manufacturers of the medication.

The Merck Veterinary Journal
iVillage: Your Total Health

SOURCE: Reglan Side Effects › Prokinetic drugs like Reglan have list of side effects

While researchers are calling this encouraging news to pregnant women, the U.S. Food and Drug Administration (FDA) says more studies must be conducted before the agency will grant approval for the drug to be used in the treatment of morning sickness. After all, the drug carries a black box warning to consumers and health care providers of a serious, debilitating and often irreversible movement disorder called Tardive Dyskinesia. Other problems, it appears, may occur when the medication is taken on a long-term basis, even for pregnant women. 

According to the Canadian research, the length of time on the drug seemed to play a role in the likelihood of birth defects. Children from mothers who took the drug just one week during the first trimester had a 4.9 percent birth defects rate, while babies from mothers who used the drug for more than three months had a 6.1 percent rate of birth defects.

Reglan is approved in the U.S. by the FDA to treat heartburn and a condition known as diabetic gastroparesis. Earlier this year, the FDA issued a black box warning on the medication warning of the increased risk of Tardive Dyskinesia. Individuals who take the medication for longer than 12 weeks are at greatest risk of developing the condition. Elderly women, especially women, are also at greater risk than the general population. Some studies put the risk as high as 20 percent among long-term uses of Reglan.

Source: Calorie Lab

SOURCE: Reglan Side Effects › Study: Effect of Reglan on increased risk of birth defects

Some patients with gastroparesis don’t respond to treatment and some may experience severe adverse events from the medication. For example, Reglan recently fell under a black box warning after reports of a serious movement disorder called Tardive Dyskinesia in some patients who took the medication. Given the risks of medication, alternative therapies like the stimulation device seem more attractive. 

During a six-month study of 34 patients with the meal-activated nerve stimulators, researchers also found that patients lost about 10 pounds and two inches from their waistline, suggesting the device may also aid in weight loss.

The device, Tantalus, manufactured by MetaCure, is made up of three electrodes that attach at one end to a pulse generator and at the other end to the distal stomach. As the device senses food intake, it transmits an electrical current to the stomach to stimulate gastric contraction.

“The minimally invasive approach combined with a low incidence of adverse events presents a potential benefit that may position this system as a valid treatment for type 2 diabetes,” says Dr. Arthur Bohdajlian, of the Medical University of Vienna in Austria. “Additional clinical benefits on conditions related to metabolic syndrome are currently being analyzed.”

The device is approved in Europe for the treatment of obesity and the management of type 2 diabetes in obese patients.

SOURCE: Reglan Side Effects › Device offers alternative treatment for gastroparesis

Tardive Dyskinesia (TD) is a disfiguring disorder characterized by involuntary movements of the face, tongue or extremities. Symptoms can include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers. The symptoms do not always go away after discontinuation of the medication.

The new labeling warns consumers and health care providers that the risk of developing TD increases with duration of treatment and total cumulative dose.

“Although the risk of TD with metoclopramide has not been extensively studied, one published study reported a TD prevalence of 20 percent among patients treated for at least 12 weeks,” the new warning states.

The labeling warns consumers and health care providers not to use the treatment for more than 12 weeks except in rare cases where the therapeutic benefit outweighs the risk of developing TD. Elderly are at greater risk, but any patient who develops signs of symptoms should stop taking the medication immediately. Metoclopramide may also suppress or partially suppress the signs of TD, thereby masking the underlying disease process.

If you or a loved one have been injured by Reglan side effects, you may have a claim against the manufacturer.

Source: FDA

SOURCE: Reglan Side Effects › FDA approves Reglan label changes to reflect black box warning

Tardive Dyskinesia is a serious movement disorder caused by Reglan that often persists long after the medication has been stopped. People with the condition generally experience involuntary movements of the face, tongue or extremities. There is no known effective treatment for Tardive Dyskinesia.

While it is hard to predict which patients are likely to develop the syndrome, both the risk of developing the condition and the likelihood that it will become irreversible are believed to increase with the duration of treatment and the total cumulative dose. Those most at risk, however, appear to be the elderly, especially elderly women.

Reglan should be discontinued in patients who develop signs or symptoms of Tardive Dyskinesia. Prolonged treatment – greater than 12 weeks – with Reglan should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risks to the patient.

Source: FDA

SOURCE: Reglan Side Effects › Study: 20 percent of long-term Reglan users develop Tardive Dyskinesia

HD symptoms include changes in personality, cognition and physical skills. Almost all patients with HD exhibit physical symptoms such as jerky, random and uncontrollable movements. Many HD patients who were prescribed Reglan “have experienced not only symptoms of neuroleptic malignant syndrome (NMS) and/or Tardive Dyskinesia, but (also) hallucinations, paranoia, suicidal thoughts, severe anger outburts, etc.,” according to Jean E. Miller, a contributor editor for HD Lighthouse, an information center and community for patients with HD and their family members. “In one HD patient, the serious side effects still hadn’t gone away 18 months after taking Reglan.”

Earlier this year the Food and Drug Administration ordered the makers of Reglan (metoclopramide) to include a black box warning on the product label warning of the risk of Tardive Dyskinesia with long-term, high-dose use of the drug. Tardive Dyskinesia is a condition in which the body moves repetitively and uncontrollably. The condition often continues even after the medication has been discontinued.

Miller says she hopes the black box warning on Reglan will make physicians more cautious when prescribing the medication for patients with HD. She also urges familys of HD patients to “exercise caution when a physician wants this medication prescribed, especially for those in the later stages of HD or on feeding tubes.”

SOURCE: Reglan Side Effects › Tardive dyskinesia in Huntington disease patients on Reglan

Tardive Dyskinesia is a neurological syndrome caused by the long-term use of neuroleptic drugs generally prescribed for psychiatric disorders, and some gastrointestinal disorders, such as metoclopramide, commonly known by the brand name Reglan. The condition causes repetitive, involuntary movements that may include grimacing; tongue protrusion; lip smacking, puckering and pursing; and rapid eye blinking. Rapid movements of the fingers, arms, legs and trunk may also occur.

There is no standard treatment for Tardive Dyskinesia. The first step is to stop or minimize the medication that is causing the condition. Symptoms of Tardive Dyskinesia may linger long after discontinuation of the drugs, however with some careful management, some symptoms may improve and/or disappear over time.

If you or a loved one has been injured by neuroleptic drugs like metoclopramide or Reglan, you may have a claim against the manufacturer and may want to seek legal consel.

SOURCE: Reglan Side Effects › Clinical trials seek treatment for Tardive Dyskinesia

Earlier this year the FDA ordered all makers of metoclopramide to provide a risk evaluation and mitigation strategy (REMS) following reports linking the drug to a serious condition in which a person develops involuntary movements of his muscles known as Tardive Dyskinesia. Those taking the medication for more than 12 weeks, elderly patients, and women are at an increased risk of developing the severe adverse reaction. There is no know cure for Tardive Dyskinesia and symptoms may persist even after the medication has been discontinued.

As a result of the REMS, the FDA elevated the warnings to a boxed warning on package inserts of metoclopramide warning of the risks associated with long-term use. Metoclopramide is perhaps most known in the U.S. by the brand name Reglan. An estimated 2 million American use some form of metoclopramide.

Source: Seeking Alpha

SOURCE: Reglan Side Effects › Salix metoclopramide drug moves closer to FDA approval

While uncomfortable, both heartburn and GER are experienced at least weekly by some 20 percent of Americans. When GER symptoms occur more than twice a week, it is considered to be the more seriuos gastroesophageal reflux disease (GERD). GERD, which affects people of all ages, can eventually lead to more serious health problems.

Conditions such as a hiatal hernia or factors such as obesity, pregnancy and smoking can contribute to GERD. Foods can aggravate the condition, such as citrus fruits, chocolate, drinks with caffeine or alcohol, fatty and fried foods, garlic and onions, mint flavorings, spi8cy foods and tomato-based foods like spaghetti sauce, salsa, chili and pizza.

GERD and GER are often treated through lifestyle changes such as avoiding food triggers, losing weight, and not lying down for three hours after a meal. Medications can also be recommended or prescribed, such as antacids, foaming agents such as Gaviscon, H2blockers such as Tagament HB and Pepcid AC, proton pump inhibitors such as prilosec and Nexium, and prokinetics, such metoclopramide, known by the brand name Reglan.

Patients should discuss with their doctors which medication would work best for their condition. Some medications, such as Reglan (metoclopramide) have side effects such as fatigue, sleepiness, depression and anxiety that limit their usefulness. Reglan also has been linked to a serious physical condition known as Tardive Dyskinesia, which causes a person to develop jerking movements of their muscles in their bodies, in particular in their face and fingers. As always, any adverse reactions experienced while taking medication should be reported to your doctor.

Source: National Digestive Diseases Information Clearinghouse (NDDIC)

SOURCE: Reglan Side Effects › Heartburn, GER, GERD treatments should be discussed with doctor

Gastroparesis

Diabetes can cause damage the vagus nerve when blood glucose levels remain high over a long period of time by damaging the blood vessels that carry oxygen and nutrients to the nerves. According to the American Diabetes Association, symptoms of gastroparesis include heartburn, nausea, vomiting of undigested food, an early feeling of fullness when eating, weight loss, abnormal bloating, erratic blood glucose levels, lack of appetite, gastroesophageal reflux or spasms of the stomach wall.

Gastroparesis is often treated by managing blood glucose levels as best as possible through insulin, oral medications or a change in diet. Medications also can be prescribed to help encourage digestion, such as metoclopramide, known by the brand name Reglan.

As with any medication, patients should be aware of any adverse reactions they experience while taking medication, and this is especially true with Reglan (metoclopramide). Earlier this year the Food and Drug Administration (FDA) issued a black box warning, the stiffest warning the FDA can require, after studies have shown that people taking metoclopramide can develop a serious condition known as Tardive Dyskinesia, in which a person develops involuntary movements of their muscles, particularly of the face and fingers.

Patients taking Reglan (metoclopramide) should consult their health care provider if they experience any adverse reactions to the medication. If you have been injured by Reglan (metoclopramide) side effects, you may have a claim against the manufacturer.

SOURCE: Reglan Side Effects › Patients with gastroparesis should weigh treatment options

Reglan, also known as metoclopramide, is generally prescribed to treat diabetic gastroparesis in adults and gastroesophafeal reflux in adults and children. Recent clinical studies have shown that it is safe for the treatment of morning sickness in women who are pregnant. However, a recent FDA warning has made people like Fiestagrill question whether the medication is causing serious injury to babies as well as children.

The FDA recently issued a black box warning – the strongest warning the FDA can require – on Reglan (metoclopramide) after reports of serious and debilitating side effects from people who were taking the medication over an extended period of time. The condition, known as Tardive Dyskinesia, is an involuntary movement of muscles that can include lip smacking, tongue thrusting, eye blinking and buldging, head jerking, facial grimacing, puckering and pursing of the lips and involuntary movements of the fingers. The condition often lingers even after the medication has been discontinued, causing serious disability.

Currently, the makers of Reglan are facing numerous lawsuits by individuals who have been harmed by the medication and are seeking justice. Could Jessica be another victim of Reglan?

Watch the video below.

SOURCE: Reglan Side Effects › Are Baby Jessica’s head jerks a side effect of Reglan?

A study of more than 80,000 births to Israeli women, a country where Reglan, also known as metocloparmide, is routinely prescribed to treat nausea in pregnant women, found that there was no difference in birth defects or other problems among women whether they were taking the drug or not. The study results were reported in this week’s New England Journal of Medicine.

No drugs to treat morning sickness are currently approved for use in the U.S. Many women worry about using medication to treat morning sickness for fear of birth defects. In the 1960s, use of Thalidomide in Europe and Canada resulted in babies born with missing or shortened limbs. Another medication, Bendectin, was pulled from the market in 1983 after reports of limb deformities.

Reglan may cause side effects, such as sedation, insomnia, depression and anxiety. Long-term use of the medication has been linked to a permanent involuntary muscle movement known as Tardive Dyskinesia, which has prompted the FDA to require its manufacturer to include a black box warning on its label. Tardive Dyskinesia is a serious condition in which a person develops Parkinson’s-like symptoms such as lip smacking, tongue thrusting, eye blinking and bulging, head jerking and facial grimacing. Even after the medication is discontinued, the condition may not go away and may severely affect one’s ability to work or perform household duties.

An estimated 2 million people use some form of metoclopramide.

SOURCE: Reglan Side Effects › Promising treatment for morning sickness, but beware of long term use

Kecia Neal

Last month, Neal filed suit against Teva Pharmaceutical, Schwarz Pharma and Wyeth Inc., makers of Reglan and its equivalent metoclopramide, after she began experiencing involuntary and repetitive movements of her body and face known as tardive dyskinesia. The condition is debilitating, and often continues even after the medication has been discontinued.

In February 2009, the Food and Drug Administration (FDA) ordered Reglan’s manufacturers to provide an additional boxed warning that “chronic treatment with metoclopramide can cause tardive dyskinesia, a serious movement that is often irreversible.” The new warnings state that “prolonged treatment (greater than 12 weeks) with metoclopramide should be avoided in all but rare cases,” however those warnings came far too late for Neal.

According to the lawsuit, patients who take Reglan for more than 12 weeks are at a 100 times greater risk for developing the disorder and other side effects.

Neal, who was on Reglan for more than a year, says she did not have access to the warnings about taking Reglan long-term. As a result, she is suffering from permanent and debilitating injuries. The lawsuit seeks damage for past and future medical expenses, physical pain and suffering, mental anguish, physical disfigurement, physical impairment, disability, psychological injury, loss of ability to provide household services, loss of earnings, and loss of earning capacity.

The case is expected to become part of a multi-district litigation.

Source: Southeast Texas Record

SOURCE: Reglan Side Effects › Woman files suit against Reglan for causing serious movement disorder

“He has been sick ever since he was born,” writes Sam Weber. Karter was diagnosed with infantile spasms when he was just two months old, and has been on the medication Reglan for digestive problems since he was just two days old. He was recently taken off Reglan, and tested for West Syndrome, a seizure disorder, but the tests came out negative. “I have a feeling that he may have TD,” Sam Weber writes. “He continues to spasm and cry and stiffen up like he is in pain.”

The Weber’s concerns about Tardive Dyskinesia may be warranted. The Food and Drug Administration (FDA) recently issued a black box warning on Reglan and its generic metoclopramide after receiving reports that long-term use of the medication has been linked to an increased risk of Tardive Dyskinesia. Individuals with Tardive Dyskinesia develop involuntary movements of their muscles. Those movements include lip smacking, tongue thrusting, head jerking, facial grimacing, and involuntary movements of the fingers.

There is no known cure for Tardive Dyskinesia, and symptoms may persist even after the medication is discontinued.

SOURCE: Reglan Side Effects › Family asks, ‘Is this Tardive Dyskinesia?’

Shirley Brinkley was prescribed Reglan by her physician in 1992 to treat a stomach ailment. According to the complaint, her physician referred to the Physician’s Desk Reference (PDR) and the medication’s package inserts and prescribed the medication for long-term use. She took the medication until April 2007.

Brinkley claims that even though the Food and Drug Administration (FDA) had approved the long-term use of Reglan, taking the medication for the prolonged period caused her to suffer from uncontrolled movements associated with Tardive Dyskinesia. Because of the condition, she has and will continue to experience medical and related expenses, loss of ability to provide household services, disfigurement, disability, pain and suffering, and psychological injury.

“Because of the misleading information that the Defendants provided to physicians and the FDA about the true risks associated with the use of Reglan and because of the failure of the Defendants and each of them to adequately inform physicians generally, including Plaintiff’s physicians, about the true risks associated with the use of Reglan, her physicians never informed her of any side effects associated with Reglan or that Reglan was only approved for short term use (up to 12 weeks),” the complaint states.

Wyeth, A.H. Robins Company Inc., and Schwarz Pharma are named in the product liability suit.

Source: Madison-St. Clair The Record

SOURCE: Reglan Side Effects › Woman with Tardive Dyskinesia sues makers of Reglan

Questcor Pharmaceuticals Inc

Diabetes is just one of the known causes of gastroparesis. The condition is generally treated through dietary changes and medications including metoclopramide, which is commonly found under the brand names Reglan, Maxolon or Clopra and is traditionally available in the form of a tablet,  oral solution or injection.

The clinical trail on Questor’s Emitasol metoclopramide nasal spray showed encouraging results in terms of safety and preliminary evaluation of efficacy in the treatment of diabetic gastroparesis. No serious adverse events were reported during the trial.

In recent months, the Food and Drug Administration (FDA) placed a black box warning on the drug metoclopramide – the strongest warning required by the FDA – after a serious condition called Tardive Dyskinesia was reported in a number of patients who took the drug. Tardive Dyskinesia is a Parkinson’s-like condition in which a person develops involuntary movements of his muscles, including lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, lip puckering and involuntary movements of the fingers. The condition can be permanent, even after the drug has been discontinued.

Questor says it plans to begin Phase III of the Emitasol study as soon as possible.

Source: PR Newswire

SOURCE: Reglan Side Effects › Clinical trial underway for metoclopramide nasal spray

Laura received a letter late last month from her GI’s office notifying her that the Food and Drug Administration (FDA) had placed a “Black Box Warning” on Reglan because it carried a risk of a rare but Parkinson’s-like condition known as known as Tardive Dyskinesia. There is no treatment for Tardive Dyskinesia, and it is often irreversible even after the medication has been discontinued.

Shortly after being prescribed Reglan (metoclopramide), Laura’s health began to decline. Her tongue started moving out of control and she began smacking her lips. She didn’t immediately make the connection between her condition and Reglan. When she contacted her physician and said she was experiencing tremors, he ordered her to cut the Reglan in half.

“Why didn’t my gastroenterologist warn me? Why didn’t he give me a choice?” she asks.

Even though she has stopped taking the medication, she still suffers from uncontrolled movements of her tongue, which cause sores on her tongue, lesions in her mouth and inflamed gums. “It’s nerve wracking,” she says. Even more concerning is that her pregnant daughter was given a prescription for Reglan to treat morning sickness. “She told (her doctor) ‘No way,’ recalling what happened to me.”

Patients who have taken Reglan in the past or are currently taking Reglan are advised to contact their health care provider even if they have not experienced any side effects from the medication. Negative side effects should be reported to the FDA online at www.fda.gov/medwatch, or by phone at 1-800-FDA-1088.

Source: RGJ.com

SOURCE: Reglan Side Effects › Woman harmed by Reglan wants to know why she was never warned

Warner Chilcott

Tardive Dyskinesia has been linked to types of antidepressants such as SSRIs (selective serotonin reuptake inhibitors) and SSNRs (serotonin-norepineprine reuptake inhibitors). It also was recently linked to gastrophageal reflux medication Reglan. Tardive Dyskinesia is often irreversible even after the drug has been discontinued.

PMDD, a condition associated with severe emotional and physical problems linked closely to the menstrual cycle, affects about 5 percent of menstruating women. Both PMDD and PMS share common symptoms such as depression, anxiety, tension, irritability and moodiness, however PMDD is far more severe. It is often treated with antidepressants and anti-anxiety drugs, such as those classified as SSRIs and SSNRs.

Sarafem is believed to correct the imbalance of serotonin that may contribute to PMDD. Although Sarafem is not a treatment for depression, it contains fluoxetine hydrochloride, the same active ingredient in some antidepressants. Like other SSRIs and SSNRs, Sarafem also carries a warning of suicidal thoughts and behavior.

Patients are advised to discuss with their doctor any side effects experienced while taking Sarafem. Negative side effects should be reported to the Food and Drug Administration (FDA) online at www.fda.gov/medwatch, or by phone at 1-800-FDA-1088.

SOURCE: Reglan Side Effects › PMDD medication linked to Tardive Dyskinesia

The FDA recently issued a boxed warning for Reglan after recent studies revealed that people on the medication can develop a serious Parkinsons-like condition called Tardive Dyskinesia.

Jennifer’s daughter only had three doses of the medication before Jennifer took her off the drug. She was never diagnosed with Tardive Dyskinesia, however the medication did cause her to become irritable and she started “flailing her arms, twitching with stiff movements and screaming uncontrollably,” Jennifer said. “As soon as we discontinued Reglan she went back to her normal behaviors.”

While Jennifer vowed to never use the drug again, she caved with her second daughter after her severe reflux nearly caused her to aspirate. The younger daughter didn’t have the same reaction to Reglan and the little girl stayed on the medication for more than a year. She did suffer developmental delays, which Jennifer’s pediatrician says was likely caused by the prolonged use of Reglan.

“I would NEVER presume to tell anyone whether to use Reglan or not,” Jennifer said. “What I will tell you is that this is not a medication that should be taken without doing research.”

Source: Health Central

SOURCE: Reglan Side Effects › Mother says FDA’s Reglan warning is long overdue

The drug is primarily used in infants to treat gastroesophageal reflux and in children and adults to treat heartburn or nausea and vomiting caused by other medications. But Reglan has a side effect of increasing the prolactin in the brain. Prolactin is the milk-making hormone. Coupled with frequent and regular breast pumping, Reglan has been shown to increase breast milk production. A small amount of the mother’s dose will transfer to her breast milk, but studies indicate that there have been no side effects to infants.

However, some reports of other, serious side effects from the use of Reglan have made breastfeeding advocates leery of the medication. Some mothers have reported feeling fatigued, irritable or depressed while taking the medication. Reglan is in a class of medications known as dopamine-blockers, which includes several antipsychotic and some antidepressants. The Food and Drug Administration (FDA) recently issued a black box warning to consumers and health care providers warning of the risk of a neurological disorder called tardive dyskinesia with the long-term or high-dose use of Reglan.

As an alternative medication to Reglan, breastfeeding experts recommend Motillium (domperidone), to increase breast milk production. Motillium does not pass the blood-brain barrier and as a result has fewer side effects.

Source: Breastfeeding Online

SOURCE: Reglan Side Effects › Breast milk-increasing medication linked to neurological disorder

Tardive dyskinesia is an often irreversible condition that is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers.

It is likely the Supreme Court decision will cost the pharmaceutical drug market “billions of dollars,” according to one attorney quoted by Bloomberg. “There’s no way to quantify it, but the number has as many zeroes in it as attacked Pearl Harbor.”

SOURCE: Reglan Side Effects › Supreme Court ruling could cost pharmaceutical industry ‘billions’

While several antipsychotic and some antidepressants have been linked to the condition, more drugs are being added to the list of possible culprits. Recently, the Food and Drug Administration (FDA) issued a black box warning to consumers and healthcare providers warning of the risk of tardive dyskinesia with the long-term or high-dose use of metoclopramide, more commonly known as Reglan, a medication prescribed for the treatment of disorders like heartburn caused by gastroesophageal reflux disease. Elderly patients, especially women, are at an increased risk of developing the condition while using Reglan.

The medicines that can cause tardive dyskinesia affect how nerve impulses are transmitted across gaps between nerve cells. This is done in part by blocking a chemical made by the body called dopamine. (Reglan is considered a dopamine receptor blocking agent.) Over time, the nerves seem to become hypersensitive to dopamine, causing abnormal movements.

There is currently no cure for the condition, however in some patients, symptoms may lesson or resolve after coming off the medication. The FDA has advised physicians to avoid long term use of Reglan except in rare cases where the benefit outweighs the risks.

SOURCE: Reglan Side Effects › Dopamine-blocking medications linked to tardive dyskinesia