Public Citizen Wants FDA To Issue Avandia Recall Order Due To "New" Liver Failure Cases

October 2008 Petition Asserts That Now The Risks Outweigh Any Benefits, And FDA Should Ban Avandia Sales In U.S.

The Health Research Group (HRG), a part of Public Citizen, submitted a Petition to the FDA on
October 30, 2008 requesting that GlaxoSmithKline's diabetes drug Avandia (rosiglitazone) be removed from the market immediately due to its several serious side effects, including some "new" cases of liver failure the HRG found recently.

This October 2008 HRG document, "Petition to Immediately Ban Diabetes Drug Rosiglitazone (AVANDIA) (HRG Publication #1848)", not only discusses the previously known cardiovascular side effects associated with Avandia, such as heart attacks, but also brings attention to recently found information concerning 14 cases of liver failure, of which 12 resulted in death.

Essentially, this Public Citizen Petition contends that a recall of Avandia by GlaxoSmithKline and the FDA is warranted, now, due to these recently discovered cases of liver failure.

Seemingly to emphasize why this "new" Avandia link to liver toxicity is so significant, Public Citizen compares Avanida to Rezulin (troglitazone) in this excerpt from their Petition:

Troglitazone [Rezulin], a thiozolidinedione similar in structure to rosiglitazone [Avandia], was approved for marketing by the FDA in March 1997, but was withdrawn from the market in March 2000 after 94 cases of troglitazone [Rezulin]-induced liver failure, the majority of which were fatal, were reported. Although the premarketing signal for hepatotoxicity with rosiglitazone [Avandia] was not as strong as the signal with troglitazone [Rezulin], one of the most hepatotoxic drugs ever approved by the FDA, several cases of rosiglitazone [Avandia]-induced hepatotoxicity have been reported in the literature, and many more via the FDA Adverse Event Reporting System (AERS). [footnotes omitted]

In conclusion, when one considers these newly discovered cases of liver failure in addition to the black box warning on Avandia's current label about increased heart attack risks -- not to mention "the accompanying lack of evidence of any clinical benefit" when Avandia is compared to other available diabetes drugs -- it seems this request by Public Citizen that the FDA order GlaxoSmithKline to recall Avandia, now, is in fact a reasonable request to make in order to ensure patient safety.

Read more about Avandia on our Avandia Information Page