After a request from the FDA on March 21, the manufacturer of troglitazone (Rezulin), a drug used in the treatment of type 2 diabetes mellitus (formerly known as non-insulin-dependent diabetes mellitus) agreed to remove the product from the market. The FDA took this action after its review of recent safety data on troglitazone and two similar drugs, rosiglitazone (Avandia) and pioglitazone (Actos), showed that troglitazone is more toxic to the liver than the other two drugs. To date, data show that rosiglitazone and pioglitazone offer the same benefits as troglitazone without the same risk. At least 61 deaths have been linked to troglitazone. "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 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 noted.
COPYRIGHT 2000 American Academy of Family Physicians
COPYRIGHT 2000 Gale Group
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