Janssen Clarifies Risperdal Risks

Last year the Food and Drug Administration (FDA) told several makers of antipsychotic drugs to update their product labels with regard to serious risks associated with taking the drugs. Janssen Pharmaceutica Products LP, which makes Risperdal, complied in November 2003. But the FDA determined that the company's promotional materials still minimized the risks of diabetes and other potentially fatal complications. The FDA also said that Janssen made misleading claims that the medication was safer in treating mental illness than other similar drugs.

In response, Janssen sent health care providers a letter dated July 21 providing “important corrective information about Risperdal relating to hyperglycemia and diabetes mellitus.”

The letter is posted at<http://psychrights.org/drugs/risperidonecorrectionocr.pdf>. More information can be obtained by calling (800) JANSSEN. ▪