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Rezulin benefit/risk ratio is supported by FDA

Executive Summary

Labeling revisions in June "have been effective in reducing the rate of reported adverse liver events" for Rezulin, Warner-Lambert says. No deaths or transplants have been reported since June, company claims. Firm declares that reports of a Rezulin withdrawal are untrue. Warner-Lambert said it has had "productive meetings with the FDA regarding Rezulin, which are part of the agency's ongoing monitoring of this therapy for type 2 diabetes," and the agency has stated that "at this time, the FDA continues to consider the benefit versus risk profile to be favorable when used according to the approved labeling"

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