Although this story says this a second FDA advisory panel’s endorsement of the diabetes drug, Avandia, it remains one which is controversial among doctors. Avandia is associated with a higher heart disease risk.

Seventeen of 20 panel members wanted tougher labeling, warnings, for the drug.

Assess your risks with your doctor based on this latest discussion and recommendation for allowing the drug to stay on the market.

Medpage Today

“An advisory panel voted 20-12 to recommend that the FDA allow rosiglitazone (Avandia) to stay on the market, but most panelists want to see the controversial diabetes drug carry tougher warnings on its label.

“Wednesday’s vote marks the second time an FDA advisory panel has essentially endorsed rosiglitazone. In 2007, a panel voted that while the drug appears to carry a higher risk of cardiovascular events, it should continued to be marketed.

“Since then, concern over the health risks of the drug has continued to grow, so the FDA convened the current panel of diabetes and statistical experts to revisit the issue. The 33-member panel was comprised of the Endocrinology and Metabolic Drugs and the Drug Safety and Risk Management Advisory Committees.”

Not Just an Up or Down Vote

“Of the 20 panel members who voted that rosiglitazone should stay on the market, only three voted that there be no changes in the product labeling; 17 voted to recommend that GlaxoSmithKline be allowed to continue marketing the drug — but with several caveats.” (Emphasis added)

…”According to Steven Nissen, MD, of the Cleveland Clinic — whose meta-analysis sparked the firestorm that culminated in this week’s advisory committee meeting — if the FDA adopts the tougher restrictions, 95% of rosiglitazone use will disappear. (Use of rosiglitazone also declined following the 2007 advisory committee meeting).”

Source: Medpage Today, July 14, 2010