FDA Panel Urges Restricting Diabetes Drug
Price, Joyce Howard, The Washington Times (Washington, DC)
An FDA advisory panel yesterday recommended that the government restrict the use of Rezulin, a diabetes drug blamed for the liver-failure deaths of 28 Americans since it came on the market in 1997.
"This is not to be used ever as a first-line drug for diabetes," said Dr. Jules Hirsch of Rockefeller University, a member of the drug advisory committee. Instead, he said, patients should try Rezulin only after determining that other, less risky, treatments don't work.
The panel spent a full day re-examining Rezulin amid growing concern about the drug used by about 750,000 U.S. diabetics to control blood-sugar levels. Rezulin is primarily used by Type 2 diabetics, or those who developed the disease as adults and may not need insulin injections.
Currently, there are at least 10 other glucose-lowering drugs on the market.
The panel concluded that Rezulin should never be used as a lone therapy, as it is now sold. It recommended that the drug only be used in combination with older diabetes medications, such as insulin, in patients not now receiving adequate treatment.
The modification, if approved by the FDA, would require a labeling change. The FDA is not bound by the advisory panel's recommendations but normally approves them.
At the hearing, FDA epidemiologist Dr. David Graham said a total of 43 Rezulin patients have suffered acute liver failure, and he said the drug itself was likely responsible for 38 of those cases.
But Dr. Graham estimates those cases represent only about 10 percent of the actual number of patients who have suffered liver damage after taking Rezulin. He went on to say the risk for liver damage increases the longer a diabetic uses Rezulin. And he created a computer model that estimates up to one in 1,800 persons who use the drug for six months will develop liver failure.
But officials of Parke-Davis, the Warner-Lambert division that manufactures Rezulin, scoffed at those figures. …