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News Summary: Consumer group sues FDA over drug

WEDNESDAY, SEPT. 5, 2012, 1:59 P.M.

SAFETY QUESTION: Public Citizen says it’s filed a federal lawsuit to force the Food and Drug Administration to remove the highest dose of an Alzheimer’s disease drug from the market over potentially fatal side effects.

DANGEROUS DELAY: The consumer group petitioned FDA in spring 2011 to remove from the market the 23-milligram dose of Aricept, saying it’s much riskier than two lower doses. Complications include vomiting, which can result in pneumonia and death.

THE RESPONSES: FDA won’t discuss the lawsuit, but says it’s doing an extensive analysis of the case. Aricept maker Eisai isn’t commenting either.



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