Avandia to Remain on the Market, but Not Without Concerns

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An advisory panel for the US Food and Drug Administration agrees that GlaxoSmithKline’s Avandia increases the risk of heart attacks and other cardiovascular problems, but does not feel there is enough data to withdraw the drug from the market at this time. The vote comes after a 2-day hearing on the safety of the anti-diabetic drug.

The panel of FDA reviewers voted 21-3 that clinical trial data on Avandia suggests more heart risks than other medicines. Nine panelists did not feel there was enough information to make a decision. However, the panel does not feel the risk of death is higher than other treatments for diabetes. Since diabetics are already predisposed to heart risks it is difficult to tell which heart attacks are drug-related and which are simply a result of the underlying disease.

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"While I'm not persuaded by the evidence to implicate the drug, I'm also not reassured by the evidence to exonerate it," said Dr. Sanjay Kaul of Cedars-Sinai Medical Center in Los Angeles.

The FDA may or may not follow the advisory panel’s ruling, but historically has followed its recommendations. The FDA can choose to pull Avandia off the market, require additional warnings on the label, or leave the drug as is. A final decision by FDA Commissioner Margaret A. Hamburg will be made in coming months.

Professional organizations have been divided on the issue. On Tuesday, groups including the American Diabetes Association, the American Association of Clinical Endocrinologists and The Endocrine Society issued a joint statement advising patients who are using Avandia to continue taking whatever medication they were on for now. On Wednesday, Robert Vigersky of the Endocrine Society argued to keep the drug on the market.

Should Avandia eventually be withdrawn from the US market, options for diabetics include oral medications Actos, Januvia, and Onglyza or injectables such as Victoza or Byetta.

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