Removal of Rezulin from the Market

American Family Physician,  May 1, 2000  by Monica Preboth

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Troglitazone (Rezulin), a drug used in the treatment of type 2 diabetes mellitus (formerly non-insulin-dependent diabetes mellitus), was recently removed from the market at the request of the U.S. Food and Drug Administration (FDA).

The withdrawal occurred after the FDA reviewed recent safety data on troglitazone and two similar drugs, rosiglitazone (Avandia) and pioglitazone (Actos), and found that troglitazone is more toxic to the liver than the other drugs. Current data show that rosiglitazone and pioglitazone provide the same benefits as troglitazone without the same risk.

Since 1997, severe liver toxicity has been associated with troglitazone. The manufacturer, in consultation with the FDA, has strengthened the labeling of troglitazone several times and has recommended close monitoring of liver function in patients using the drug.

In March 1999, the Endocrine and Metabolic Drugs Advisory Committee of the FDA reviewed the status of troglitazone and its risk of liver toxicity. The committee recommended continued availability of the drug in a select group of patients--those whose diabetes is not well-controlled by other drugs.

Since that time, the FDA has monitored adverse events associated with troglitazone, as well as rosiglitazone and pioglitazone. After monitoring the two newer drugs for about a year, it became clear that they have less risk of severe liver toxicity than troglitazone.

For more information on the removal of troglitazone, contact the FDA at 888-INFO-FDA (888-463-6332). This information can also be accessed on the FDA Web site (http:// www.fda.gov).

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