FDA seeks 'Black Box' warning for Avandia, Actos

During the June 2007 congressional hearing into the Food and Drug Administration’s (FDA’s) approval process of the diabetes drug Avandia , FDA Commissioner Andrew von Eschenbach announced that the agency was seeking a “Black Box” warning for both Avandia and competitor Actos – but not for heart attack risk, as some had hoped. Instead, the FDA has determined that these drugs can lead to fluid buildup in the body, and that in turn can lead to congestive heart failure. Although that's still serious and can result in death, it is a much different condition than a heart  attack, which also has been linked to Avandia use.

GlaxoSmithKline, the company that makes Avandia, did not immediately comment about the FDA’s Black Box warning request. Further, the FDA has not made any official announcement or outlined the details about this warning in a press release.

The congressional hearing comes as a result of a May 21, 2007 study printed in the New England Journal of Medicine (NEJM) that shows Avandia could raise the risk of heart attack by as much as 43%. Although this was a retrospective study of already-published research, the authors admit that there is not enough data to prove the risk conclusively. Some say that publishing this study was “irresponsible” of the NEJM, while others suggest that since Avandia has been on the market for eight years, the company and the FDA had plenty of time to provide or commission an accurate safety profile for Avandia.

Whether or not this safety profile should have been provided before the FDA approved Avandia is another matter. This, along with an investigation into what the FDA knew about the raised heart attack risk and what it did about, is the key focus of the congressional hearing.

And despite the study’s well-covered drawbacks, this could be some of the most important research that the NEJM has ever published. In the short term, it has spurred both Congress and the FDA to take a closer look at Avandia, what risks it poses, and perhaps most importantly why those risks weren’t identified sooner. In the long term, this could be the issue that prompts the long-needed FDA overhaul.

If you or a loved one has suffered heart attack, congestive heart failure or any other major injury while taking Avandia, contact an Avandia lawyer with Jim S. Adler & Associates. We may be able to help you secure a settlement package to cover your medical bills and lost work, and compensate you for your pain and suffering. Don’t settle for less. Call Jim S. Adler & Associates right now or enter the details of your Avandia injury in the form on this page for a free legal review of your case.