Black box warnings on Risperdal

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In April of 2005, the FDA determined that the use of Risperdal among elderly patients with dementia is associated with increased mortality. This was in response to more than a dozen placebo-controlled experimental trials with several atypical antipsychotic medications.

As a result of this determination, the agency requested that the manufacturers of Risperdal include a black box warning on the drug. This warning is in regards to patients suffering from dementia, a condition for which the drug is not approved.

Black box warnings are the most serious warnings incorporated into the labeling of a prescription medication. In addition to their role in informing patients of serious health risks, black box warnings also serve to prevent drug manufacturers from advertising their product’s availability to healthcare professionals.