FDA Asks Drugmakers to Add Black-Box Warning on Certain Antipsychotic Drugs

The FDA recently issued a public health advisory requesting that manufacturers of certain antipsychotic drugs place black-box warnings on their products to inform healthcare providers and patients that the drugs can be dangerous when used off-label to treat behavioral disorders in elderly patients with dementia.

The advisory applies to "atypical antipsychotics" such as Abilify (aripiparozole), Zyprexa (olanzapine), Seroquel (quetiapine), Risperdal (risperidone), Clozaril (clozapine), Geodon (ziprasidone) and Symbyax (olanzapine/fluoxetine), the FDA said in an talk paper. These drugs are currently approved to treat schizophrenia and mania, but recent clinical studies have tested the drugs as treatments for behavioral problems in elderly patients with dementia. Patients taking atypical antipsychotics in those trials had a death rate approximately 1.6 to 1.7 times higher than patients receiving a placebo, the FDA said.

The FDA asked manufacturers to add a boxed warning to their drug labels describing this risk and noting that these drugs are not approved for the treatment of behavioral symptoms in elderly patients with dementia.

For more information, go to http://www.fda.gov/cder/drug/advisory/antipsychotics.htm (http://www.fda.gov/cder/drug/advisory/antipsychotics.htm).