Avandia May Get Second Black Box Warning

November 4, 2007. By Heidi Turner

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Rockville, MD: US Food and Drug Administration (FDA) officials are now pushing for a second black box warning to be added to [Avandia's] label. Avandia currently carries a black box warning for heart failure; however, the FDA wants a second warning about the risks of heart attack.

The second warning would be more serious than the first and could result in further decreased sales of the diabetes drug. According to an article in the Wall Street Journal (October 24, 2007), the new warning would focus on the risk of ischemic problems in which blood is prevented from reaching the heart. The FDA has said that Avandia is linked to a 38% increased risk of ischemic events.

Meanwhile, Senator Charles Grassley has asked the FDA to confirm that an FDA internal board decided to keep Avandia on the market by a one-vote margin. The senator's letter states that the FDA held a private meeting of the Drug Safety Oversight Board (DSOB) on October 2 at which the board decided in an 8-7 vote that Avandia would be left on the market.

Grassley's concern arose because even though DSOB meetings are private, minutes are generally made public. However, even though this most recent DSOB meeting was held in early October, by late October nothing about the meeting had been publicized.

Avandia has come under fire since an analysis showed a 43% increased risk of heart attack in patients who took the drug. In October the Department of Veterans Affairs removed Avandia from its national formulary. According to Grassley's letter, at the FDA DSOB meeting the Department of Veterans Affairs also voted to remove Avandia from the market.

Many patients have suffered heart attacks, heart failure and fluid retention as a result of taking Avandia for their diabetes. The FDA has so far found that the benefits of Avandia outweigh the risks. However, can a drug that carries two black box warnings really be doing more good than harm? Two black box warnings seem like a lot for one drug to carry, especially when black box warnings are the most serious warnings a drug label can carry. Should patients really be taking a drug that has that many risks associated with it?

Patients who are concerned about the risks of Avandia should consult with their physician about possible alternatives. Do not stop taking Avandia without first speaking to a doctor.

Lawsuits have been filed against GlaxoSmithKline alleging that the company knew about the risks associated with its diabetes drug but did not properly warn the public. People who have had loved ones die of heart attacks following the use of Avandia have also filed lawsuits.

Avandia Legal Help
If you or a family member have used Avandia and have suffered heart attack or liver damage after taking Avandia, please contact a lawyer involved in a possible [Avandia Lawsuit] who will review your case at no cost or obligation.
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