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Rezulin Recall: Fast-Moving FDA Hits a New Speed Bump


"As a new modality, it really established a new important treatment for controlling blood sugars," Barry Goldstein, MD, PhD, director of endocrinology at Jefferson Medical College in Philadelphia, tells WebMD.

Supporters of the "fast track" process also point out that this recent spate of drug withdrawals are in part due to the misuse of prescription drugs by both doctors and patients. Asked whether Rezulin's liver damage ever concerned him, Goldstein says "No. This came up in the very beginning, and it was predictable."

In 1999, Goldstein switched the majority of his patients to Avandia (rosiglitazone) which, along with Actos (pioglitazone), is in the same class as Rezulin but believed to be safer. But he still believes that Rezulin's withdrawal was "unwarranted." His present concern is that pressure may now be put on the FDA to relabel or withdraw other drugs in this class, although bowing to this outside pressure "would not in the best interests of patients."

"I think many people are now confused by the way the FDA makes decisions," he tells WebMD.

In an earlier interview with WebMD, the FDA's chief reviewer for this class of drugs, David Orloff, MD, said the agency's preference is to change a drug's label rather than withdraw it. Side effects can be limited if the doctor knows what to expect, he told WebMD.

John Jenkins, MD, a deputy director at the FDA's Center for Drug Evaluation, tells WebMD, "We don't know everything about a drug when it is approved. These rare Rezulin-related liver failures are a demonstration that no drug is without risk, and that those risks constantly must be re-evaluated."

Jenkins also argues that Rezulin was not approved under the "fast track" process. That process, he tells WebMD, did not even exist when the agency received the approval application for Rezulin. However, he says, the agency did give the drug a priority review because it believed at that time that this drug represented an important advance.

The agency has made significant strides in cutting down its overall approval times for all drugs. The average approval time in 1988 was almost 30 months for the approval of 68 new products. In 1999, the agency approved 77 products in an average of about 13 months.

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