FDA seeks "black-box" warning for older antipsychotics
NEWS IN BRIEF — Posted July 7, 2008
The Food and Drug Administration on June 16 exercised its new authority under a law enacted last fall to require manufacturers of older antipsychotic drugs to place a "black-box" warning on the drugs' labels. The warning cautioned about the increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia.
The so-called older antipsychotics, which are referred to as "conventional," include such drugs as Compazine, Haldol and Loxitane.
Newer antipsychotics, commonly called "atypical," already were required to have a black-box warning about the same risk. Among them are Clozaril, FazaClo and Risperdal. The drugs are approved for treating symptoms associated with schizophrenia.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2008/07/07/hlbf0707.htm.