REZULIN WITHDRAWN FROM MARKET

On March 21, 2000, the Food and Drug Administration asked Parke-Davis, the manufacturer of Rezulin (troglitazone) to remove the drug from market.� The manufacturer agreed.

FDA took this action after its review of safety data in Rezulin and two similar drugs, rosiglitazone (Avandia) and pioglitazone (Actos) showed that Rezulin is more toxic to the liver than the other two drugs.� Data to date show that Avandia and Actos, both approved last year, offer the same benefits as Rezulin, without the same risk.

�When considered as a whole, the pre-marketing clinical data and post-marketing safety data from Rezulin as compared to similar alternative diabetes drugs indicate that continued use of Rezulin now poses an unacceptable risk to patients,� said Dr. Janet Woodcock, Director of the FDA�s Center for Drug Evaluation and Research.� �We are now confident that patients have safer alternatives in this important class of Diabetes Drugs,� she said.

�Severe liver toxicity has been known to occur with Rezulin since 1997.� After consultation with the FDA, Parke-Davis strengthened warnings on the label several times, and recommended close monitoring of patients� liver function.� In March 1999, the FDA reviewed the status of Rezulin, and at that time recommended its use be limited to those patients not well-controlled on other medications.

After up to nine months of marketing experience with Actos and Avandia, it has become clear those two have less risk of severe liver toxicity than did Rezulin.� The U.S. Department of Health and Human Services says: �Patients using Rezulin are urged to contact their physicians for information about alternative treatments.� Patients should not discontinue taking Rezulin or any other treatment for diabetes without discussing alternative therapies with their physicians.�