Avandia-FDA Seeks Black Box Warning

Greg Owen

Attorney

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Lawmakers are hearing testimony from GlaxoSmithKline, doctors and regulators. The drugs Avandia, Avandaryl and Avandament, all GSK diabetes drugs, will be discussed at length. The discussion will be centered around whether enough was done by the drug maker GlaxoSmithKline to warn the public of the dangers involved with taking these medications, which are considered to be defective drugs by many.

The FDA has requested that GlaxoSmithKline add a stronger warning to its drug labels - 'black box' warnings. The warnings would alert consumers to the risk of congestive heart failure as a result of using these drugs. However, adding a warning of the risks of heart attacks was not addressed. The hope is that this hearing will force changes at the Food and Drug Administration and will pave the way for stronger drug safety measures.

GSK has stated that outsids studies are inadequate, and that their current labels are adequate as is. They fear that a stronger warning would hurt sales. Well, on a positive note, at least GaxioSmithKline have made their priorities clear.

GSK shares fell 95 cents in midday trading to $50.95.