FDA is criticised for licensing high dose donepezil

BMJ 2011; 342 doi: (Published 25 May 2011) Cite this as: BMJ 2011;342:d3270
  1. Jeanne Lenzer
  1. 1New York

A watchdog body has described the US Food and Drug Administration’s approval of a new dose of a drug to treat Alzheimer’s disease as “inexcusable,” saying that the single study used to win approval failed to show that the dose was safe or effective.

Public Citizen, a non-profit, public interest consumer organisation that is based in Washington, DC, filed a petition on 18 May with the FDA calling for it to withdraw the new 23 mg pill of donepezil (marketed in the United States as Aricept). The organisation also suggested that profits, not science, might be behind the approval.

The FDA approved the higher dose of the drug, which is normally given in 5-10 mg doses, even …

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