Public Citizen sues FDA for failing to ban dangerous dose of Aricept

The Food and Drug Administration has dragged its feet for too long on a petition calling on the agency to stop allowing the drug Aricept (donepezil), marketed by originator Japan’s Eisai (TYO: 4532) and US drug behemoth Pfizer (NYSE: PFE) to be marketed at doses that can cause severe – and even fatal – side effects, US consumer advocacy group Public Citizen said in a law suit filed this week. The suit asks the court to compel the FDA to act.

The suit follows a petition from Public Citizen last year (The Pharma Letter  May 19, 2011) urging the FDA to immediately remove from the market a 23mg dose of Aricept and to add to lower-dosage (5mg and 10mg) forms of Aricept and the generic counterpart, donepezil, warnings against use at a higher dosage. The agency has yet to act on the petition.

Aricept was approved in 1996 as a treatment for Alzheimer’s at a dose of 5mg or 10mg daily. Before the patent expired in November 2010, Eisai sought approval for a 23mg version, on which it would have an additional period to market without generic competition.