26 Eylül 2010 Pazar

FDA Restricts Use of Diabetes Drug Avandia

By Daniel J. DeNoon
WebMD Health News

Reviewed by Laura J. Martin, MD

Sept. 23, 2010 -- The FDA will not ban Avandia -- but stringent restrictions will make it far harder for doctors to prescribe the safety-troubled diabetes drug.

The European Medicines Agency took harsher action. European sales of Avandia-containing drugs will be suspended over the next few months, although the agency did not formally withdraw approval.

The 600,000 U.S. patients currently taking Avandia can continue to take the drug only if their doctors officially attest that their patients understand the risks, that the drug is helping them, and that no other diabetes drug can keep their blood sugar under control.

SOURCES:FDA news teleconference, Sept. 23, 2010. Margaret A. Hamburg, MD, commissioner, FDA.Janet Woodcock, MD, director, Center for Drug Evaluation and Research, FDA.FDA web site.FDA internal memo from Gerald J. Dal Pan, MD, to Janet Woodcock, MD, Sept. 12, 2010.FDA decision on continued marketing of Avandia, Avandamet, and Avandaryl, Janet Woodcock, MD, Sept. 22, 2010.News release, GlaxoSmithKline.



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