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 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

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

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

Salix Pharmaceuticals

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

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

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

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

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

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

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

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

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

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

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

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

Source: Madison-St. Clair The Record

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