Public Citizen says US FDA should immediately pull Eisai and Pfizer's high-dose Aricept from market

19 May 2011

US consumer watchdog Public Citizen has called for higher doses of Aricept (donepezil), marketed by originator Japan’s Eisai (TYO: 4532) and US drugs behemoth Pfizer (NYSE: PFE) and used to treat moderate or severe cases of Alzheimer’s disease, to be removed from the market immediately because of its risk of serious adverse effects and its lack of effectiveness. In a petition filed yesterday with the US Food and Drug Administration the advocacy group was joined by an eminent geriatrician from Johns Hopkins.

Aricept has been approved by the FDA in a dose of 5mg to 10mg for patients with mild to moderate cases of Alzheimer’s disease and in a dose of 10mg or 23mg for patients with moderate to severe Alzheimer’s. Public Citizen is calling for the 23mg dose to be immediately pulled from the market.

Aricept sales already down due to generic competition

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