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.
- Pharmaceuticals & Drug Trials
- Food and Drug Administration
- Public Citizen