RxLink

July 21, 2004

From: Janssen Pharmaceutica Inc.

Health care Provider:

The Food Drug Administration's (FDA) Division of Drug, Marketing, Advertising, and Communications (DDMAC) has asked us to contact you because Janssen Pharmaceutica Products, L.P. recently received a warning Letter concerning the promotion of Risperdal (risperidone). This letter provides important corrective information about Risperdal relating to hyperglycemia and Diabetes Mellitus.

The Warning Letter concludes that Janssen disseminated a Risperdal Dear Health Care Provider (DHCP) dated November 10, 21003 that omitted material information about Risperdal, minimized potentially fatal risks, and made misleading claims suggesting superior safety to other atypical antipsychotics without adequate substantiation, in violation of the Federal Food, Drug and Cosmetic Act.

Specifically, the Warning Letter stated that the DHCP letter omitted important information regarding hyperglycemia and diabetes, including the potential consequences and the recommendation of regular glucose control monitoring that was added to the approval product labeling for Risperdal; minimized the potentially fatal risks of hyperglycemia-related adverse events such as ketoacidosis, hyperosmolar coma and death; minimized the importance of blood glucose monitoring; suggested that Risperdal did not increase the risk of diabetes, contradicting the Warning in the revised product labeling; and made misleading claims suggesting that Risperdal has a lower risk of hyperglycemia and diabetes than other atypical antipsychotics without adequate substantiation which is inconsistent with the Prescribing Information for Risperdal.

In order to provide you with complete and accurate information regarding hyperglycemia and Diabetes Mellitus relative to Risperdal, please be advised that the Risperdal Prescribing Information was updated with addition of the Warning in November 2003.