July 25, 2004

Risperdal Risks Clarified by Janssen Pharmaceutical

Via the Washington Post:  Janssen Pharmaceutical Products LP, the makers of Risperdal, the leading drug used in the treatment of schizophrenia and other psychotic disorders, has sent a 2-page letter to health care professionals clarifying the safety risks associated with the medication. According the the Post article:

The letter stems from a directive issued last year by the Food and Drug Administration, which told several makers of anti-psychotic drugs to update their product labels.

Janssen complied in November 2003, but the FDA determined that the company's promotional materials still minimized the risk of strokes, diabetes and other potentially fatal complications. The agency also said Janssen made misleading claims that the medication was safer in treating mental illness than similar drugs.

(It is unclear from Janssen's webpage on Risperdal risks whether the webpage reflects the contents of Janssen's new letter and thus is consistent with the FDA's directive.)

July 25, 2004 at 08:45 AM in Medical News, Schizophrenia | Permalink