Risperidone Linked to Stroke, Transient Ischemic Attack

April 25, 2003

Medscape Staff Report

April 25, 2003 — The labeling of the anti-schizophrenia drug risperidone (Risperdal) is being revised, according to a notice posted on the U.S. Food and Drug Administration (FDA) Web site today.

In a letter to healthcare providers dated April 16, Janssen Pharmaceuticals, the maker of risperidone, described adverse event reports that prompted the label revision: "Cerebrovascular adverse events (eg, stroke, transient ischemic attack), including fatalities, were reported in patients in trials of risperidone in elderly patients with dementia-related psychosis." Risperidone has not been shown to be safe or effective in the treatment of patients with dementia-related psychosis, Janssen said.

In addition, a significantly higher incidence of cerebrovascular adverse events was seen in patients treated with risperidone compared with those treated with placebo. This label update was based on data from a study of 1,230 patients with demention in four placebo-controlled trials conducted in elderly patients with dementia. Janssen emphasized in the letter that risperidone is not indicated for the treatment of dementia.

New adverse events related to risperidone may be reported to the FDA's MedWatch program by phone 1-800-FDA-1088, by fax (1-800-FDA-0178), or online (https://www.accessdata.fda.gov/scripts/medwatch/).

Reviewed by Gary D. Vogin, MD

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