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Popular Diabetes Drug Rezulin Pulled from Market
September 2000, Injury Law News
The FDA has asked the manufacturers of Rezulin (traglitazone) - a drug used to treat type 2 diabetes mellitus - to remove the product from the market. The drug's manufacturer, Parke-Davis/Warner-Lambert, has agreed to FDA's request.
FDA took this action after its review of recent safety data on Rezulin and two similar drugs, rosiglitazone (Avandia) and pioglitazone (Actos), showed that Rezulin is more toxic to the liver then the other two drugs. Data to date show that both drugs 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 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 added.
Severe liver toxicity has been known to occur with Rezulin since 1997. In consultation with FDA, Parke-Davis has strengthened the drug is labeling several times and has recommended close monitoring of liver function in those patients taking Rezulin.
In March 1999, FDA's Endocrine and Metabolic Drugs Advisory Committee reviewed the status of Rezulin and its risk of liver toxicity and recommended continued availability of this drug in a select group of patients - patients not well-controlled on other diabetes drugs.
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