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Lawsuit Seeks Ban on High-Dose Alzheimer’s Drug

Filed September 6th, 2012 Laurie

The consumer advocacy group Public Citizen filed a lawsuit against the U.S. Food and Drug Administration on Wednesday which accused the agency of dragging its feet for too long on a petition calling on them to stop the drug Aricept from being marketed at doses that can cause severe or fatal side effects.

Public Citizen said that the agency’s own researchers found that high doses of Aricept don’t work better at controlling symptoms of moderate-to-severe Alzheimer’s than two low doses. According to the group, the higher dose of the drug can lead to vomiting, which, in Alzheimer’s patients, can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture or death.

The advocacy group filed a petition with the FDA in May 2011 urging them to halt sales of the 23-milligram dose of Aricept and put safety warnings about the high-dose risks on two low doses, 5 and 10 milligrams. So far, the FDA has responded with silence.

The lawsuit asks the court to declare the FDA’s failure to act unlawful and to order the agency to decide within 30 days of the court’s ruling whether to approve Public Citizen’s request.

Aricept was approved in 1996 to treat Alzheimer’s when given at a dose of 5 or 10 mg daily.

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