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Conventional Antipsychotics to Carry Boxed Warning

Manufacturers must add a boxed warning to conventional antipsychotic drugs to alert physicians and patients to the increased mortality risk in elderly adults treated for dementia-related psychosis, the FDA announced on Monday.

The warning is similar to that issued in 2005 for atypical antipsychotics.

The agency based its decision on two observational studies, comprising 64,500 elderly adults, in which the risk for death with conventional antipsychotics was similar to — and possibly greater than — the risk associated with atypical antipsychotics.

LINK(S):

FDA alert (Free)

2005 advisory on atypical antipsychotics (Free)

Associated Press story (Free)

Journal Watch General Medicine coverage of study showing increased mortality with conventional antipsychotics (Your Journal Watch registration required)

Published in Physician's First Watch June 17, 2008

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