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FDA Won't Remove High Aricept Dose

Tue, 11/06/2012 - 5:56pm

WASHINGTON (AP) -- A consumer group that pressed the Food and Drug Administration to remove the highest dose of an Alzheimer's disease drug from the market says the agency has rejected its request.

Public Citizen said late Tuesday the FDA declined to withdraw the 23-milligram dose of Aricept, made by Japan's Eisai Co. Lt, following a lawsuit filed against the agency.

The consumer advocacy group first petitioned the agency over the drug in May 2011, saying the high dose has more dangerous, potentially deadly side effects including vomiting, which in Alzheimer's patients "can lead to pneumonia, massive gastrointestinal bleeding, esophageal rupture or death." The group asked the FDA to halt sales of the highest dose of Aricept and put safety warnings about the high-dose risks on two lower doses of 5 and 10 milligrams.

In September the group filed a lawsuit in federal court to compel the agency to respond to the petition. The agency denied the request in a letter sent to the group Tuesday.

"Allowing drug manufacturer Eisai to exploit and harm vulnerable patients with Alzheimer's disease is unconscionable," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, in a statement.

He noted that Aricept is the best-selling Alzheimer's drug of all time, with sales of $2.4 billion in 2010. Sales have declined since the drug lost patent protection in the U.S.

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