Impact of FDA Black Box Advisory on Antipsychotic Medication Use

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Abstract
The first atypical antipsychotic, clozapine, was introduced in the United States in 1989, followed by risperidone, olanzapine, and most recently, paliperidone (2006). Many agents that were initially approved to treat schizophrenia have been subsequently approved by the Food and Drug Administration (FDA) to treat mania associated with bipolar affective disorder and irritability associated with autism.1 Although they are less likely to cause extrapyramidal adverse effects (eg, parkinsonism) than conventional or typical antipsychotics,2 several safety concerns have arisen regarding atypical agents, including a 2003 Medwatch warning3 about increased risk of stroke with risperidone use and a 2004 warning about an association between atypical drug use and hyperglycemia and diabetes.4