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

Harris’ lawsuit, on behalf of her minor child, claims the defendants “encouraged the long term use of these drugs, and concealed the drug’s dangerous side effects.” Last year, the Food and Drug Administration (FDA) ordered that a black box warning be placed on Reglan (metoclopramide) warning against long term use (greater than 12 weeks) of the drug because of the risk of Tardive Dyskinesia. Harris’ lawsuit claims the defendants were well aware of the drug’s serious side effects but failed to adequately warn users of the risk.

“Defendants breached these warranties (both express and implied) as the Reglan/metoclopramide was not merchantable, was unfit for its intended use and was unreasonably dangerous when comparing the benefits to the risks associated with its use,” the complaint states.

Harris’ lawsuit is filed against Pharmaceutical Associates, Beach Products, Morton Grove Pharmaceuticals, and Wockhardt. Harris is seeking damages for medical expenses, physical pain and suffering, mental anguish, physical disfigurement, physical impairment, loss of earning capacity, pre- and post-judgment interest and court costs.

SOURCE: Reglan Side Effects › Woman blames Reglan for causing her young child permanent disability

Tardive Dyskinesia is an involuntary movement disorder that causes repetitive movements of the face and limbs. These movements include lip smacking, grimacing, tongue protusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movements of the fingers. It is a debilitating condition whose symptoms often do not go away even after the offending medication has been stopped.

Metoclopramide was originally used to treat psychosis in patients, but the drug showed more promise in controlling gastrointestinal disorders and is now largely used for this purpose. Neuroleptic drugs like metoclopramide, which also includes anti-psychotic drugs, have been associated with movement disorders and other serious side effects since the 1990s.

In 2000, Cisapride, another anti-psychotic drug that was also released as a gastrointestinal medication, was discontinued after it was found to cause cardiac complications in patients treated with the medication. This likely delayed the reporting of adverse events associated with metoclopramide.

Until the black box warning was issued earlier this year, metoclopramide safety labels indicated Tardive Dyskinesia was a rare side effect and did not warn against long-term use of the drug. In the interim, doctors freely prescribed the drug without knowledge of the serious problems it could cause over time. As a result, hundreds of people have filed suit against the makers of metoclopramide claiming they were not adequately warned of the dangers of taking the heartburn medication.

SOURCE: Reglan Side Effects › Long-term use of heartburn drug can cause serious movement disorder

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

Nearly a year later, Whitener saw a television commercial about the adverse events linked to the heartburn drug Reglan. The medication had recently been hit with a black box warning after numerous reports of consumers who took Reglan and developed a serious involuntary movement disorder known as Tardive Dyskinesia. Whitener also learned that the drug was not approved by the Food and Drug Administration (FDA) for use during pregnancy, though some studies suggested it was a safe treatment for morning sickness. Whitener spoke with various health care professionals and none could rule out the possibility of Reglan causing or contributing to her son’s birth defects.

Whitener and Lucas’ father Joshua A. Whitener, Sr., both individually and on behalf of Lucas, have filed a lawsuit against Pliva Inc., Pliva USA, Pliva Pharmaceuticals Inc., Barr Laboratories, Barr Pharmaceuticals, Watson Pharmaceuticals, Teva Pharmaceuticals Industries, Teva Pharmaceuticals USA, Rue De Sante Women’s Center, and John McCrossen. The Whiteners are seeking damages for pain and suffering, permanent disabilities, fear, mental anguish, loss of love and affection, loss of companionship, grief and mental anguish, loss of society and consortium, loss of personal service, loss of support, medical expenses, lost wages, and other financial loss/detriment.

SOURCE: Reglan Side Effects › Lawsuit blames Reglan for causing son’s birth defects

Tardive dyskinesia is a disorder that causes involuntary movements, especially in the lower face. Symptoms include facial grimacing, jaw swinging, repetitive chewing and tongue thrusting. It is a serious side effect from long-term use of antipsychotic drugs as well as metoclopramide, but sometimes the condition occurs with short-term use of the medication. The condition may be reversed if it is diagnosed early and the medication is stopped; however, in many cases, the involuntary movements may be permanent and in some cases may become significantly worse.

Last year, the Food and Drug Administration (FDA) issued a black box warning on Reglan (metoclopramide) after numerous reports of consumers developing tardive dyskinesia after taking the drug. The label now warns of the risk of the disorder with long-term (12 weeks or more) use of the drug.

Bennett took Reglan (metoclopramide) as an acid reflux treatment from December 2008 to May 2009 and developed tardive dyskinesia. He claims the defendant provided inaccurate, misleading, incomplete, false and inadequate information about the risks in taking Reglan (metoclopramide). He is 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.

SOURCE: Reglan Side Effects › Louisiana man sues maker of acid reflux medication Reglan

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

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

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

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

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

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

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

The Merck Veterinary Journal
iVillage: Your Total Health

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

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?

Kecia Neal

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

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

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

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

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

Source: Southeast Texas Record

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

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’