Consumer group sues FDA over Aricept safety

September 5, 2012 by The Associated Press

(AP)—A consumer group pressing the Food and Drug Administration to remove the highest dose of an Alzheimer's disease drug from the market is suing the agency for "foot-dragging."

Public Citizen says the FDA's own reviewers found that high-dose Aricept (AR'ih-sept) doesn't work better than two low doses but has more-dangerous, potentially deadly side effects.

Public Citizen filed a petition in 2011 with the FDA. The group urged the agency to halt sales of the 23-milligram dose of Aricept and put about the high-dose risks on two low doses available under the brand and as generic pills.

The FDA has yet to act. A spokeswoman says FDA doesn't comment on litigation. Last December, the agency wrote to Public Citizen, saying it was doing a review of the case.

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