Antipsychotic Class Warning On Cerebrovascular Events Under FDA Review

FDA is considering class labeling for atypical antipsychotics on an increased risk of cerebrovascular events in elderly dementia patients.

Class labeling on cerebrovascular adverse events is "under active review," the agency said.

Labeling for Lilly's Zyprexa (olanzapine), Johnson & Johnson's Risperdal (risperidone), and Bristol-Myers Squibb/Otsuka's Abilify (aripiprazole) already carry warnings on cerebrovascular events in elderly dementia patients.

The warning was added to Abilify labeling March 1, at the same time the product received a bipolar maintenance indication.

"In placebo-controlled clinical studies...of dementia-related psychosis, there was an increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, in aripiprazole-treated patients (mean age: 84 years; range: 78-88 years)," Abilify labeling states.

Similar language was added to Risperdal labeling in September 2003 and to Zyprexa labeling in January 2004. None of the atypical antipsychotics are approved for treatment of dementia-related psychosis.

Labeling for Pfizer's Geodon (ziprasidone) and AstraZeneca's Seroquel (quetiapine) do not contain the cerebrovascular warning. Both companies said FDA has not requested that they add such a warning.

A recently released study of Seroquel in elderly Alzheimer's disease patients found that quetiapine was "generally well-tolerated with no incidence of cerebrovascular adverse events during treatment," AstraZeneca said. "In the 30-day follow up, one cerebrovascular event was reported in the 100 mg/day group."

AstraZeneca said it has provided the Seroquel data to FDA, but it is not pursuing a dementia indication at this time. Pfizer has no completed studies of Geodon in elderly patients, although studies are underway, the company said.