NEW YORK (AP) -- The controversial diabetes drug Rezulin -- implicated in more than two dozen deaths -- will survive moves by federal regulators to restrict its use, although sales will likely fall short of Wall Street's once lofty expectations.
Many doctors will continue to prescribe the Warner-Lambert drug because it is one of the most powerful available to control blood sugar, securities analysts predicted Monday. However, diabetes experts said doctors remain divided on the drug because of its potential to cause liver damage."This will not relieve the uncertainty in the medical community," said Dr. Seth Braunstein, chief of the diabetes program at the Hospital of the University of Pennsylvania in Philadelphia. "Many doctors will still be hesitant to use the drug," he said.
Rezulin could also face new challenges from two competitors that are awaiting final government reviews later this year.
Rezulin was approved by the Food and Drug Administration in January 1997 to treat the growing number of patients with adult-onset diabetes, the kind that develops with age and prevents the body from making enough insulin to control blood sugar. About 750,000 Americans take Rezulin.
A Food and Drug Administration advisory panel on Friday recommended keeping Rezulin on the market, but said the drug should no longer be used alone. Rather, Rezulin should be only used in combination with older treatments and only after other less risky therapies fail, the committee said. The FDA isn't bound by its advisers' decisions, but usually follows them.
Warner-Lambert called the panel's action a reaffirmation of Rezulin's usefulness.
Rezulin recorded $748 million in sales last year, and before the controversy heated up, some analysts were expecting $1 billion in sales this year.
Rezulin is the fourth most prescribed diabetes pill, and the second highest selling drug in Warner-Lambert arsenal after cholesterol lowering drug Lipitor.
Questions about whether Rezulin damages the liver have plagued the drug since shortly after its introduction.
The FDA found 43 patients have suffered acute liver failure after taking Rezulin for several months and the drug probably caused 38 of the cases. Twenty-eight died, seven survived only with liver transplants and five recovered without transplants. The FDA has not determined what happened to the other three.
Complaints about Rezulin rose sharply after it was on the market and was used by tens of thousands of patients. The liver problems were hard to detect during testing because, like most drugs, these tests were conducted on only a few thousand patients.
Wall Street analysts said Monday that the committee's recommended restrictions will curtail some sales of the drug because it will no longer be used alone.
The losses will be tempered because some doctors may actually begin prescribing the drug now that the FDA panel has offered additional guidance.
"The meeting was definitely positive for Warner Lambert and Rezulin," said Sergio Traversa, an analyst with the research firm Mehta Partners.
Added Jeffrey Kraws, analyst with Everen Securities: "This clears the air for doctors sitting on the fence."
But Richard Kahn, chief scientific and medical officer of the American Diabetes Association, said doctors who had doubts about Rezulin will still have them. "There won't be a dramatic shift in prescribing behavior," he said.
Doctors want newer weapons against diabetes. That's because existing medications tend to lose their effectiveness as the disease progresses and victims of adult-onset diabetes often suffer blindness or must have limbs amputated.
Those weapons may soon be available.
Next month, an FDA advisory panel will review Avandia from SmithKline Beecham PLC and Actos from Eli Lilly & Co. and Takeda Chemical Industries Ltd. Analysts say the drugs may face more scrutiny by the FDA because of the issues surrounding Rezulin.
The newer drugs will make Rezulin obsolete by later this year, said Dr. Sidney Wolfe, director of the Public Citizen Health Research Group, a consumer advocacy organization. "It's dead," he said of Rezulin. Wolfe had pushed to stop the Rezulin's sale.