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

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 (TD) is a disfiguring disorder characterized by involuntary movements of the face, tongue or extremities. Symptoms 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 symptoms do not always go away after discontinuation of the medication.

The new labeling warns consumers and health care providers that the risk of developing TD increases with duration of treatment and total cumulative dose.

“Although the risk of TD with metoclopramide has not been extensively studied, one published study reported a TD prevalence of 20 percent among patients treated for at least 12 weeks,” the new warning states.

The labeling warns consumers and health care providers not to use the treatment for more than 12 weeks except in rare cases where the therapeutic benefit outweighs the risk of developing TD. Elderly are at greater risk, but any patient who develops signs of symptoms should stop taking the medication immediately. Metoclopramide may also suppress or partially suppress the signs of TD, thereby masking the underlying disease process.

If you or a loved one have been injured by Reglan side effects, you may have a claim against the manufacturer.

Source: FDA

SOURCE: Reglan Side Effects › FDA approves Reglan label changes to reflect black box warning