Risperdal Manufacturer Admits Misleading Claims, Minimizing Risks

Janssen Pharmaceuticals, makers of Risperdal, has notified healthcare providers that its promotional material on the antipsychotic medication minimized possibly fatal safety risks and made misleading claims about the drug's effectiveness as well.

In 2003 the US Food and Drug Administration ordered makers of several antipsychotic drugs to make updates to their product labels. After Janssen did so, the FDA determined that the changes were not adequate. Now Janssen, a subsidiary of Johnson & Johnson, has informed the healthcare community that it has previously downplayed the risk of dangerous complications, including strokes and diabetes. In addition, the company admits its claims about Risperdal's being more effective than other similar medications were misleading.

As of the date of this writing (7/24/04), the information at the website www.risperdal.com appears not to have been updated in light of the notification Janssen Pharmaceuticals sent out. Stroke and diabetes are not even mentioned on the "Safety and Tolerability" page in the section for healthcare providers. Claims for significantly better effectiveness over both olanzapine (Zyprexa) and haloperidal (Haldol) are still on the site. We would expect the website to be revised shortly.