The FDA Approves the Sale of Avandia
Earlier this week it was announced that a medical advisory panel recommended that the diabetes drug, Avandia, be pulled from the shelves or be strictly regulated due to its history of increasing the risk of heart attacks.
The FDA cracked down on the drug’s maker, GlaxoSmithKline, due to the fact that they failed to report heart failure as a negative side effect. Though it was recommended that the product be pulled from the shelves, the FDA did not adhere to the recommendation. The panel voted yesterday to keep the drug on the shelves; however, they will be required to have a stricter warning label. The vote was 20-12 to keep Glaxo’s drug on the market.
“Following today’s recommendations, we will, of course, continue to work with the FDA in the best interest of diabetes patients who face this chronic and serious disease,” said Ellen Strahlman, Glaxo’s chief medical officer. “Patients taking Avandia should speak with their physician about their treatment and any questions they may have regarding the safety of the medicine.”
While the FDA generally follows the recommendations from the medical advisory panel, they are not required to do so. This was the case with Avandia as the panel felt that the benefits outweighed the risks.