Reglan was approved by the Food and Drug Administration (FDA) for the treatment of gastrointestinal conditions such as chronic heartburn, severe acid reflux or GERD, nausea, and gastroparesis. One year ago, after numerous reports of people using Reglan developed the often permanent and debilitating movement disorder, the FDA placed a black box warning on the drug warning physicians and consumers that using Reglan increased one’s risk of developing Tardive Dyskinesia. A black box warning is the strongest warning the agency can give and is reserved for drugs that carry a significant risk of serious or even life-threatening adverse effects.

But Reglan also carries under the WARNINGS AND PRECAUTIONS section of its safety label a risk of developing depression. Some cases are mild, but others can be quite severe and may involve suicidal thoughts or behaviors. Because of this, consumers should tell their health care provider if they have depression or a history of depression. People who are prescribed Reglan should also be monitored for any signs of depression.

If you or someone you know is taking Reglan and has concerns or questions about the medication, contact your health care professional. Any side effects with this or any other medication should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.

SOURCE: Reglan Side Effects › Using Reglan can make you depressed

Tranzyme Pharama

Tranzyme Pharma’s drug candidate would be an alternative to a drug for gastroparesis that now carries a black box warning. Reglan (metoclopramide) is a prescription treatment for gastroparesis that just recently received an FDA black box warning following reports that linked the medication to a serious and involuntary movement disorder known as Tardive Dyskinesia. A black box warning is the most serious type of warning the agency can issue and is reserved for drugs that carry a significant risk of serious or even life-threatening adverse events.

Alternatively, Tranzyme Pharma reported that all three doses of TZP-102 were effective, safe and well tolerated by participants in the clinical trial. The company is now gearing up for a 12-week study to test the drug’s efficacy and safety in patients who have gastroparesis.

Last month, Tranzyme Pharma announced an agreement with Netherlands-based Norgine to develop and commercialize TZP-101, another treatment for gastrointestinal disorders.

SOURCE: Reglan Side Effects › Diabetic gastroparesis treatment shows well in clinical trials

Reglan (metoclopramide) was approved by the Food and Drug Administration in 1979 for the short term treatment of various gastrointestinal disorders. But last year, after numerous adverse event reports, the FDA issued a black box warning – the strongest of its kind – on Reglan and generic versions of metoclopramide, stating that the medication had been linked to Tardive Dyskinesia. The movement disorder has been most often associated with some antipsychotic drugs, but about a third of the cases of Tardive Dyskinesia are linked to Reglan (metoclopramide).

An estimated two million people take metocloopramide, including children and infants. While it is approved to treat conditions such as severe heartburn, gastroesophageal reflux disease (GERD) and gastroparesis, or the delayed emptying of stomach contents, it also has an off-label use in the treatment of migraine headaches and morning sickness in women who are pregnant.

The makers of Reglan and generic versions of the drug are now facing numerous lawsuits from people like August, who are suffering permanent disability because of the drug. The Macalusoes allege they were never appropriately warned of the risk of developing Tardive Dyskinesia, and now it’s too late.

Source: News Observer

SOURCE: Reglan Side Effects › Man suffers permanent disability from heartburn drug

The drug trend report looked at prescription drug spending growth between 2001 and 2009 and found that prescription drug use among children has grown four times higher than the overall population. More than one in four insured kids and nearly 30 percent of adolescents (10-19 years of age) took at least one prescription medication to treat chronic conditions.

The most substantial increases were seen in the use of antipsychotic, diabetes and asthma drugs over the past nine years. But drugs to treat hypertension and gastroesophageal reflux disease, or GERD, have climbed as well. The number of children and infants taking some form of prescription heartburn medication to treat GERD or colic increased by a startling 147 percent.

How safe are these medications for children? A study published last week in The Archives of Internal Medicine shows that use of these drugs increases the risk of infection by Colstridium difficile, a harmful intestinal bacteria. And some medications can have even more dangerous side effects.

For example, the prescription drug Reglan (metoclopramide), used to treat severe heartburn and GERD in both adult and pediatric patients, carries a black box warning that long term use may cause patients to suffer from Tardive Dyskinesia, a severe movement disorder. The drug can mask symptoms of the condition, which can get worse and even linger long after the medication has been discontinued.

SOURCE: Reglan Side Effects › More children taking prescription drugs to treat chronic conditions

Wyeth, Inc

Wyeth and Schwarz originally developed the brand-name metoclopramide, Reglan. They were released from litigation by U.S. District Judge Marcia A. Crone. The case is expected to be ready for trial by January 2011.

Metoclopramide is a medication approved by the Food and Drug Administration (FDA) in 1989 to treat gastrointestinal conditions such as severe heartburn, gastrointestinal reflux disease (GERD) and gastroparesis, or delayed emptying of the stomach contents. Over the years, the FDA has received numerous reports of users of metoclopramide suffering from Tardive Dyskinesia, and last year the agency issued a black box warning on metoclopramide products warning users that long-term use of the drug – 12 weeks or more – considerably raised one’s risk of developing the movement disorder.

Tardive Dyskinesia is a condition in which a person develops involuntary movements of his muscles. These movements include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, pucker and pursing of the lips, and involuntary movements of the fingers. Symptoms often continue even after the drug has been discontinued. To date, several lawsuits have been filed in courts throughout the U.S. against the makers of Reglan and generic metoclopramide.

SOURCE: Reglan Side Effects › Generic Reglan makers released from Tardive Dyskinesia lawsuit

Researchers with Pediatrix Medical Group analyzed data from 49,777 infants born between 2003 and 2008 with a birth weight of 501-1,500 grams – or 1 to 3 pounds. The goal of the study was to determine the effectiveness of a multi-faceted quality improvement intervention in reducing the use of many medications that have not been adequately studied in this group, that have not demonstrated clinical benefits, or that carry adverse effects to neonatal patients. The medications targeted were the antibiotic cefotaxime, gastrointestinal medications metoclopramide and H-2 blockers, the diuretic spironolactone, and the hormone erythropoietin.

Metoclopramide, known by the brand name Reglan, has never been approved by the Food and Drug Administration (FDA) for use in premature infants. It is prescribed to patients to treat severe heartburn or gastroparesis, a delayed emptying of the stomach contents. The drug carries a black box warning that long-term use (12 weeks or greater) significantly increases one’s risk of a serious and debilitating movement disorder known as Tardive Diskineia.

The study compared baseline medication usage in 2003 to post-intervention usage in 2008. Following the quality improvement intervention initiatives from 2005-2007, researchers found that use of the targeted medications was significantly reduced.

SOURCE: Reglan Side Effects › Quality improvements reduce drug usage among neonatal community

In that time, more and more patients were developing a serious involuntary movement disorder known as Tardive Dyskinesia. Symptoms of the condition include lip smacking, tongue thrusting, eyes blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers. There is no known cure for Tardive Dyskinesia and the symptoms may persist even after the drug has been discontinued. The drug can also mask symptoms, aggravating them after the medicine has been discontinued.

In February 2009, the FDA issued a black box warning on Reglan and all metoclopramide products warning consumers and health care professionals that long-term use (12 weeks or more) of the drug can elevate one’s risk of developing the condition. Some studies show long-term users of Reglan were as much as 20 percent greater risk of developing Tardive Dyskinesia.

Unfortunately for Valerie, she developed Tardive Dyskinesia. Her tongue is enlarged and she can no longer speak. Even though she has discontinued her use of Reglan, the symptoms still persist.

Source: People’s Pharmacy

SOURCE: Reglan Side Effects › Long-term use of Reglan can cause serious neurological problems

Salix Pharmaceuticals

Salix received FDA approval for Metozolv last September, offering an alternative to the metoclopramide pill known by the brand name Reglan. Reglan received a black box warning from the FDA last year after long-term (12 weeks or more) use of Reglan was linked to a serious involuntary movement disorder known as Tardive Dyskinesia.

As another version of metoclopramide, Metozolv is also required to carry the same warning on its label and provide adequate warnings of the serious side effect in its marketing materials. By not doing so, the FDA said, “these violations are concerning from a public health perspective because they suggest that Metozolv ODT is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience, and encourage use in circumstance other than those for which the drug has been shown to be safe and effective.”

However, the warning did not affect the company’s stock, which rose $1.74 last week to close at $37.41. If Salix does not correct the violations, the company could face FDA regulatory action.

SOURCE: Reglan Side Effects › Salix stock soars despite FDA warning letter

When we first told you about Mary, she was gearing up for an innovative surgery that would place a device called the Enterra into Mary’s abdomen. Her doctor, Richard McCallum, founding chair at the Paul Foster School of Medicine at Texas Tech University, called it a very powerful anti-nausea, anti-vomiting tool. For Mary, it was a glimmer of hope. “Even if my symptoms got 50 percent better, it would be a huge change in my day,” she said. 

Milder cases of gastroparesis can be treated through diet changes, however many sufferers must turn to medications such as Reglan (metoclopramide). But medication is not always an option for patients who must be on them for several months or years. Reglan has a black box warning against long-term use of the drug (more than 12 weeks) because it can cause a serious movement disorder known as Tardive Dyskinesia.

For Mary, surgery seemed to be the most logical solution.

Just days after surgery, Mary told News Channel 9 that her dreams were realized. She is able to eat and drink things she wouldn’t have even dared to try before surgery. “I’ve been eating ice cream every night, so it’s a whole new world,” she said.

SOURCE: Reglan Side Effects › Gastroparesis sufferer finds relief through surgery

The letter goes on to say that “these violations are concerning from a public health perspective because they suggest that Metozolv ODT is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience, and encourage use in circumstance other than those for which the drug has been shown to be safe and effective.”

The FDA approved Metozolv in September for the treatment of GERD, gastroparesis, and other acid reflux conditions. It is the first fast-dissolving version of metoclopramide, a drug also known by the brand name Reglan. Its projected annual sales could reach $50 million.

Last year the FDA ordered a black box warning be placed on Reglan after numerous reports of a serious involuntary movement disorder known as Tardive Dyskinesia developing in patients who took Reglan. The same black box warning was to be placed on Metozolv when it became available in the U.S. However, upon review, the FDA says Salix fell short of adequately warning patients of the risks associated with Metozolv.

The FDA is ordering Salix to immediately stop the dissemination of the violative promotional materials for Metozolv and to submit a written response to its warning letter explaining how the company will comply with the agency’s request. Failure to correct the violations could result in regulatory action, including seizure or injunction without further notice.

SOURCE: Reglan Side Effects › FDA warns makers of acid reflux drug to change warning label

Melissa Kotlen Nagin

Reglan, or metoclopramide, is a medication approved by the Food and Drug Administration (FDA) for the treatment of heartburn and GERD. It is also prescribed, off label, to help stimulate lactation, “but it is definitely not as benign as Domperidone, which carries with it virtually NO side effects,” she says.

For one, Reglan can cause depression in mothers who are already more susceptible to depression because of hormone changes following childbirth. But Reglan also carries an FDA black box warning. Long-term use of Reglan greatly increases a woman’s risk of a serious involuntary movement disorder known as Tardive Dyskinesia. The condition can be debilitating and often does not go away, and often worsens, after the medication is discontinued.

Nagin’s advice? “If you are having milk supply issues, be sure to see a lactation consultant ASAP! The longer you wait, the more intense the process to get your supply back to where it should be.”

SOURCE: Reglan Side Effects › Lactation specialist warns against use of Reglan

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

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

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

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

Dystonia is a neurological movement disorder that can be disabling. Those who suffer from the condition experience muscle contractions that cause twisting and repetitive movements or abnormal postures. The causes are not completely known or understood, but it is believed to be either inherited or caused by factors such as birth-related or physical trauma, infection, poisoning (such as lead poisoning), or reaction to drugs (such as Reglan, also known as metoclopramide, a common medication to treat heartburn, GERD and gastroparesis). For one athletic young woman, the cause was likely due to a seasonal flu shot.

25-year-old Desiree 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

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

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

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 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