Long-Term Reglan Used Linked to Reglan Tardive Dyskinesia

Long-Term Reglan Used Linked to Reglan Tardive Dyskinesia

Reglan, a drug used to treat digestive disorders, has been associated with a movement disorder called tardive dyskinesia. Tardive dyskinesia causes involuntary and repetitive movements of the body. Score of people from around the country have filed tardive dyskinesia lawsuits against Wyeth Pharmaceuticals, the maker of Reglan, as well as the manufacturers of its generic equivalents.

In February 2009, the U.S. Food & Drug Administration (FDA) mandated that the makers of Reglan add a black box warning to its label regarding the risk of tardive dyskinesia associated with chronic, long-term use. The FDA’s mandate followed the publication of analyses that suggested that Reglan is the most common cause of drug-induced movement disorders. A black box is the FDA’s strictest safety warning.

Tardive dyskinesia is characterized by:

• Involuntary/ repetitive movements of the extremities
• Facial tics
• Lip smacking, pursing and puckering
• Face Grimacing
• Tongue protrusion
• Rapid eye movements or blinking
• Impaired movement of the fingers.
• Restless Leg Syndrome (RLS)

There is no treatment or cure for tardive dyskinesia. While stopping Reglan may relieve some symptoms in some patients, in other patients the symptoms of tardive dyskinesia actually worsen when Reglan is discontinued.

To prevent tardive dyskinesia, Reglan should not be taken for more than 12 months, and it has not been approved for longer user. However, it has become apparent that doctors have been prescribing Reglan for much longer periods. Reglan tardive dyskinesia lawsuits allege that Wyeth Pharmaceuticals knew of a widespread tendency among physicians to mis-prescribe Reglan, and promoted the drug for longer use despite the lack of safety data to support such uses.

A number of tardive dyskinesia lawsuits also name the manufacturers of generic forms of Reglan as defendants. Earlier this month, the U.S. Court of Appeals for the Firth Circuit rejected the argument by a generic drug maker that federal law preempts a state-law failure-to-warn claim filed by a user of generic Reglan who developed tardive dyskinesia.

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