FDA Approves Diabetes Drug Called Alternative to Rezulin

The Food and Drug Administration on Tuesday approved a new diabetes pill that is believed to be far less dangerous to the liver than its chemical cousin, Rezulin.

The new pill, called Avandia, is made by SmithKline Beecham PLC of Britain and will be co-promoted in the United States by New Jersey-based Bristol-Myers Co.

“We are delighted about the approval of Avandia,” said Jan Leschly, chief executive of SmithKline, adding: “We plan on making the product commercially available within the next few days.”

Some diabetes specialists have said that they will be less fearful of prescribing patients Avandia than Rezulin, which has been proved to cause some degree of liver injury in about one of every 50 patients who take it. Dr. David J. Graham, the FDA’s senior epidemiologist, has estimated that one in 1,800 Rezulin patients has suffered acute liver failure.

Avandia becomes one of 11 or more pills on the U.S. market for treatment of adult-onset Type 2 diabetes. The pills lower blood-sugar levels by varying means. They are not intended for those with juvenile-onset Type 1 diabetes.

FDA officials are concluding a reassessment of the safety of Rezulin and are expected to announce soon whether, for the fourth time, the agency will change the drug’s label, seek to narrow its use or order it withdrawn from the market. After a fast-track review by the FDA, Rezulin went on the market in March 1997.

SmithKline said in a prepared statement Tuesday that there “have been no reported cases of drug-related jaundice” during clinical studies of Avandia. Both Avandia and Rezulin are of the same chemical class, called thiazolidinediones.