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

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March 22, 2000 (Washington) -- As the dust begins to settle around the latest drug to get withdrawn from the market, experts are raising new questions about the merits of the system that brought the drug to the public in the first place. In the span of just two years, the antihistamine Seldane (terfenadine), the obesity drugs Ponidimin (fenfluramine) and Redux (dexfenfluramine), the prescription painkiller Duract (bromfenac sodium), and now the diabetes drug Rezulin (troglitazone) -- all have been withdrawn from the market. And all were among the several "fast track" drugs approved by the FDA.

It all began when acting FDA Commissioner Michael Friedman, MD, got a letter from Congress reminding him that recent amendments to the FDA's regulations were passed to ease the approval of drugs that "address an unmet medical need." In other words, accelerate the process of drug review by the FDA to bring some new drugs to the market faster. But now, in light of the voluntary withdrawal of Rezulin from shelves on Tuesday, which was linked to about 63 deaths from liver damage, that process, once heralded for modernizing an aging agency, quickly is becoming a major point of contention.

Critics of the accelerated process argue that though "fast track" approvals may serve an important purpose in terms of life-threatening conditions such as HIV, the withdrawal of Rezulin, a diabetes drug, demonstrates that the system is being abused. The fast track process played an instrumental role in getting Rezulin on the market, although, according to Sidney Wolfe, MD, director of the consumer watchdog group Public Citizen, that drug should have never been approved.

"Much of the problem lies with the FDA having lowered its safety standards, but [the] fast track [process] is being abused," Wolfe tells WebMD. His organization played a large role in Rezulin's eventual withdrawal from the market. "This drug wasn't a breakthrough."

Rezulin was approved in 1997 under accelerated review process because health care professionals argued that the drug represented a new treatment option for patients whose diabetes could not be controlled using older medications.

"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."

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