Impact of FDA Black Box Advisory on Antipsychotic Medication Use

The 2005 US Food and Drug Administration (FDA) “black box” advisory warning that atypical antipsychotic drugs increased risk of death with elderly patients with dementia led to fewer mentions of the drugs by physicians in the four years after implementation of the drug label requirement. Safety concerns about increased risk of mortality associated with the use of atypical antipsychotic drugs in elderly patients with dementia led the FDA to require drug manufacturers to include a “black box” warning on their labels beginning in 2005.

These researchers examined the affect of that action on clinicians’ mentions during office visits of atypical antipsychotic drugs—including clozapine, risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, and paliperidone—with their patients 65 and older who had dementia.

Atypical antipsychotic drug mentions from January 2003 to March 2005 (before the warning) were up 54 percent annually overall; 16 percent for elderly patients with dementia. After the warning, from May 2005 to December 2008, the number of atypical antipsychotic drug mentions decreased two percent annually overall and 19 percent for those with dementia. Out of all drug mentions for those over 65 with dementia, mentions of atypical antipsychotics went from a high of 19 percent to nine percent in 2008.

Declines in atypical antipsychotic drug use in the general population (not the target of the warning), call attention to the need for more customized regulatory actions directed to specific segments of patients, in order to reduce the unintended “spillover” effect of warnings.