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FDA Panel To Consider Removal of Diabetes Drug Avandia

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I previously wrote about the FDA’s issuance of a safety alert about Avandia following publication of a report in the New England Journal of Medicine about the increased risks of heart attack from use of this diabetes drug.

Today a panel of outside experts convened by the FDA is meeting to consider removal of Avandia from the market, or at least restrictions on its use. According to a slide presentation prepared for the meeting by FDA scientist Dr. David Graham, the risks outweigh the benefits, justifying removal of Avandia from the market. An epidemiologist who has worked for many years for the FDA, drug safety advocate David Graham was named in 2004 as a “Face of The Year” by Forbes Magazine which observed that Graham has been “credited to some degree with the withdrawals of Abbott Laboratories’ Omniflox, Wyeth’s Fen-Phen and Redux, Warner-Lambert’s Rezulin, over-the-counter drug PPA, and Merck’s Vioxx “

GlaxoSmithKline, the manufacturer of Avandia, will certainly be resisting any substantial restriction on use of the drug, which is one of its best sellers. We’ll be monitoring this story.

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.