Reglan Side Effects » serious adverse events

Black box warning on Reglan came too late for some

Jennifer Walker-Journey — Tue, 09 Feb 2010 17:20:10 +0000

Metoclopramide, known by the brand name Reglan, is one of the leading medications prescribed to treat gastroesophageal reflux disease (GERD) and gastroparesis, a condition in which the stomach takes too long to empty its contents. What many don’t know is that metoclopramide was first used to treat psychosis in patients, but it was found to show more promise as a drug to treat gastrointestinal disorders. Unfortunately, like many medications used to treat psychosis, metoclopramide also increased one’s risk of developing a severe movement disorder known as Tardive Dyskinesia.

Tardive Dyskensia is a condition in which a person develops involuntary movements that can include lip smacking, facial grimacing, tongue thrusting, eye blinking and bulging, head jerking, and involuntary movements of the fingers. It can be debilitating for those who suffer from the condition. Metoclopramide carries the greatest risk when it is taken for 12 weeks or longer. Women and the elderly are at higher risk, and there is known know cure. Even after stopping the medication, the symptoms may persist.

In early 2009, the Food and Drug Administration (FDA) issued a black box warning – the agency’s sternest warning reserved for drugs that carry a risk of serious adverse events – on metoclopramide, urging doctors to avoid long-term use of the drug except in rare cases where the benefits outweigh the risks. That warning came too late for many patients, who are now handicapped because of the medication.

SOURCE: Reglan Side Effects › Black box warning on Reglan came too late for some

Ruling: patients may sue generic drug makers under state law

Jennifer Walker-Journey — Mon, 11 Jan 2010 16:59:26 +0000

The U.S. Fifth Circuit Court of Appeals has found in favor with a lower court that patients may sue generic drug makers under state law for failing to provide adequate warnings about potential side effects with their drugs. The ruling extends a 2009 U.S. Supreme Court ruling governing makers of name-brand drugs. The issue of whether generic drug companies should be held liable for not adequately warning consumers has divided several district courts, which can increase the odds of a Supreme Court review in the future, according to U.S. Circuit Judge Patrick Higginbotham.

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