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

When a person with a normally functioning digestive system swallows, the lower esophageal sphincter acts as a trap door by relaxing and allowing for food and liquids to move into the stomach. Then the muscle tightens, closing this door. For people who suffer from gastro-esophageal reflux disease, also known as GERD, that trap door doesn’t close all the way, or it opens too often, so the gastric acid flushes up into the food pipe. This can cause inflammation in the esophagus and bothersome burning heartburn. If this acid continues to burn the esophagus, over time it can lead to more serious issues, such as bleeding or breathing problems, and even cancer.

The molecular imaging study included 49 participants who were scanned upright with a special device that studied how their esophagus muscles and lower-esophageal sphincter were functioning. The test was then performed while patients were lying face down. While patients reported varying degrees of symptoms, almost half showed some problem with their esophagus while lying down, suggesting that abnormal esophageal motility may be the culprit in developing acid reflux.

Researchers hope these findings into the cause of GERD may lead to more drug treatments. Most acid reflux patients are treated with over-the-counter or prescription medications which can only be taken for a short period of time and can lead to serious health consequences.

SOURCE: Reglan Side Effects › Acid reflux study may lead to new treatments

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

Gastroesophageal reflux disease

“I recently met a lady visiting from Iran. She has been coughing for seven years. She had seen numerous physicians and had been tested extensively in Iran. She had no word for heartburn although she described, through a translator, ‘a volcano going off in my chest,’” writes Dr. Kurt Barrett in the Battle Creek (Michigan) Enquirer. While she sat in his office, Dr. Barrett gave the woman a dose of medicine to treat GERD. She said she felt an improvement. After a week she told Dr. Barrett her nagging cough was almost completely gone. She had used no cough syrups or inhalers, just the acid reflux medication.

Another uncommon symptom of GERD is hiccups, Dr. Barrett says. “You can prove it to yourself by trying over the counter Gaviscon (an antacid that foams/floats on top of the stomach contents) for immediate relief of hiccups.”

If heartburn symptoms persist or worsen, a medical professional should be consulted. Prescription medication, such as Reglan (metoclopramide) may be necessary. Be sure to discuss with your health care professional any risks or adverse events associated with your heartburn medication.

SOURCE: Reglan Side Effects › Less common symptoms of GERD can make diagnosis difficult

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

In his consolidation request to the administrative director of the courts of New Jersey, Judge Codey warned that more lawsuits against the manufacturers of Reglan would likely increase in the months to come. “Cases have started coming to Essex on a weekly basis.” Plaintiffs have until May 14, 2010 to comment or object to the application for consolidation.

Reglan and its generic metoclopramide are prescribed for the treatment of gastrointestinal conditions such as severe heartburn and acid reflux, gastroesophageal reflux disease (GERD), and gastroparesis, a condition where the stomach takes too long to empty its contents. Long-tern use (12 weeks or longer) has been associated with the involuntary movement disorder 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.

All lawsuits filed against Reglan allege that the manufacturers of the drug did note adequately warn consumers of the elevated risk of Tardive Dyskinesia with taking the medication.

SOURCE: Reglan Side Effects › New Jersey judge calls for consolidation of Reglan lawsuits

Mederi Therapeutics Inc

“Our treatment induces collagen deposition. We create small thermal lesions which reform the lower esophageal sphincter and restore it to normal function,” Mederi CEO Will Rutan told Mass Device. “There are substantial, long-term data demonstrating high effectiveness rates and durability beyond four years, so it not only works, but it lasts.”

Curon Medical Inc., received clearance from the Food and Drug Administration (FDA) a decade ago to market the device. The company went bankrupt in 2006, paving the way for Mederi to acquire its assets. Mederi re-submitted the application for Stretta to the FDA and won clearance six months ago.

The product offers an alternative to patients who suffer from the severe acid reflux condition. GERD is often managed through diet and lifestyle changes but many require medication, such as Reglan (metoclopramide) in order to find relief. However, medications can have serious side effects.

Stretta’s target market is the 20 percent of GERD sufferers who cannot find relief through drugs or surgical intervention.

SOURCE: Reglan Side Effects › New device uses radiofrequency to offer relief to GERD sufferers

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

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

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

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

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

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

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

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

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

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

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 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

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

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

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

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

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