Reglan, also known by the generic metoclopramide, is a prescription medication used to treat severe heartburn, acid reflux, gastroparesis and other gastrointestinal problems. Last year, after numerous reports to the Food and Drug Administration (FDA) of patients who took the drug and then developed Tardive Dyskinesia, the FDA ordered that a black box warning be placed on Reglan. The label now warns against long-term use – 12 weeks or greater.

The condition is marked by involuntary movements of the muscles and 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. In some cases, it can cause involuntary movements of the legs. Tardive Dyskinesia is debilitating and oftentimes the symptoms do not subside even after the medication has been stopped.

Hundreds of lawsuits have been filed against people who developed the serious movement disorder after taking Reglan or one of its generic equivalents. They say that the makers of the drug were fully aware of the dangers it could cause but they did nothing to warn patients or their doctors until thousands were already suffering from the condition.

SOURCE: Reglan Side Effects › Restless leg syndrome turns out to be movement disorder caused by Reglan

Hundreds of people who have been harmed by Reglan have already filed lawsuits against the manufacturers of the drug. Reglan is approved by the FDA to treat chronic heartburn and acid reflux as well as diabetic gastroparesis, or delayed emptying of the stomach contents. The agency placed a black box warning on the drug after numerous reports of people taking the drug developing a debilitating involuntary movement disorder known as tardive dyskinesia. The condition causes symptoms 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. In many cases, the symptoms do not go away even if the medication has been stopped.

Reglan is available by the brand name or generics as metoclopramide. Its various formulations include tablets, syrups, injections and oral disintegrating tablets. An estimated 2 million people use some form of Reglan. Individuals who believe they are suffering from complications from Reglan are encouraged to talk to an attorney, as they may be entitled to compensation.

SOURCE: Reglan Side Effects › Time is running out for victims of Reglan to file lawsuits

Essential tremors is a slowly progressive neurological disorder that is most recognized by tremors of the arms during voluntary movements such as eating and writing. Essential tremors may also occur in the head or neck, jaw and voice as well as other body regions. It is not unlike tardive dyskinesia, another neurological disorder that causes involuntary movements of the muscles and can include lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, puckering and pursing of the lips, and involuntary movements of the fingers.

The heartburn medication Melissa was prescribed, Reglan, also known by the generic name metoclopramide, has a black box warning on its safety label stating that patients taking the drug are at risk for developing the movement disorder.

“I am so sorry to hear you have tremors,” Gina responded to Melissa. “I was on Reglan … and I heard all the awful reports about tardive dyskinesia. Did you know that people are now suing for damages because of this drug? Look on the Internet. It’s full of ads of lawyers and warnings about this rotten drug that needs to be removed from the market.”

Gina is correct. In fact, hundreds of lawsuits have been filed against the makers of metoclopramide from people who are suffering from tardive dyskinesia and claim they were not adequately warned that they could develop the condition. Tardive dyskinesia is debilitating. There is no known cure, and the symptoms often linger even after the medication has been stopped. Those who have filed lawsuits say they would never have taken the drug if they knew it would harm them.

SOURCE: Reglan Side Effects › Doctor: woman’s ‘essential tremors’ caused by heartburn drug Reglan

Reglan is a medication commonly used to treat gastrointestinal conditions such as severe heartburn or acid reflux, and diabetic gastroparesis, a condition in which the stomach takes too long to empty its contents. It is indicated as a short-term therapy to be used for no more than 12 weeks. Studies have shown that long-term use of Reglan puts users at a 1-in-5 risk of developing tardive dyskinesia. The condition causes sufferers to develop symptoms 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. The condition can be permanent, continuing even after the offending medication has been stopped.

Both lawsuits claim that the drug’s manufacturers didn’t adequately warn users that they were at risk for developing tardive dyskinesia. Both Keeper and Austin are seeking damages for medical expenses, physical pain and suffering, mental anguish, physical disfigurement, physical impairment, loss of earnings, loss of earning capacity, court costs, and interest.

Reglan and the generic metoclopramide now carry an FDA boxed warning about the risk of developing the movement disorder.

SOURCE: Reglan Side Effects › Two more lawsuits filed against makers of heartburn drug Reglan

According to the complaint, Swicegood was prescribed 10 mg Reglan to be taken four times daily. Reglan is the brand name equivalent of the generic metoclopramide. Metoclopramide is made by various pharmaceutical companies but the active ingredient is the same as the name brand. Swicegood says she followed her doctor’s orders but developed Tardive Dyskinesia. Studies suggest that long-term use of metoclopramide – 12 weeks or more – puts users at a startling 20 percent greater risk of developing the condition.

Swicegood’s lawsuit is one of more than 150 that have been filed against drug makers on behalf of plaintiffs who say they were not warned of the serious side effects of metoclopramide. The first lawsuit was filed in 1998. More than a decade later – February 2009 – the Food and Drug Administration (FDA) issued a black box warning on metoclopramide alerting physicians and patients of a risk of Tardive Dyskinesia.

Last spring, the U.S. Judicial Panel on Multidistrict Litigation denied a request to consolidate the federal litigation on metoclopramide lawsuits, saying it was more appropriate for them to be heard in different courts throughout the U.S.

SOURCE: Reglan Side Effects › Reglan (metoclopramide) jury trial to begin next week

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

Though the drugs have warning labels, the woman claims she was not adequately warned of the potential for serious side effects of the drug she was prescribed, in particular the severe movement disorder known as Tardive Dyskinesia.

Makers of generic Reglan, Teva Pharmaceuticals Industries Ltd., and Mylan Inc.’s UDL Laboratories said the lawsuit should be preempted by federal law because it would require them to write labels that stray from the brand-name drug’s label. The 8th U.S. Circuit Court of Appeals in St. Louis ruled against the generic drug makers, citing a 2009 Supreme Court decision against Pifzer Inc.’s Wyeth that said Food and Drug Administration drug regulations do not protect a drug company from being sued under state law or drug labeling. Congress could have made a provision that preempted drug-labeling lawsuits against generic drug companies but did not do so, the 8th Circuit said.

The Supreme Court is asking the U.S. Solicitor General’s office whether the Obama administration believes the court should consider the appeal.

Source: Wall Street Journal

SOURCE: Reglan Side Effects › Supreme Court considers whether generic Reglan makers can be sued

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

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

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

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

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

Watch the video below.

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

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

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

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