FDA Sued Over High Dosage of Eisai Inc. and Pfizer Inc.'s Alzheimer's Med

Published: Sep 06, 2012

A public watchdog has filed a lawsuit against the FDA for allowing a high dosage of the Aricept medication for Alzheimer’s disease to remain on the market. In its suit, Public Citizen charges the pill has not demonstrated “greater efficacy than the lower doses, but has more severe — and potentially life-threatening – side effects.” Aricept, which is made by Eisai and sold by Pfizer, was approved by the agency for patients with moderate to severe Alzheimer’s. The lawsuit comes more than a year after the watchdog filed a citizen’s petition asking the agency to ban the 23mg dose and to warn doctors and patients against taking a 20mg dose – or combining lower 5m or 10mg pills. The petition also sought similar warnings on the generic version. The agency, however, has not acted on the petition and so Public Citizen maintains the agency violated the law.

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