Liver Failure Cases Tip Avandia Risk Benefit Balance
*** Avandia® Labeling Update 2/4/11: The FDA has notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of Avandia (rosiglitazone) has been added to the physician labeling and patient Medication Guide. Additionally, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:
- In patients already being treated with these medicines
- In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).
Free Avandia Case Evaluation: If you or a loved one has suffered from liver failure or other complications as a result of taking Avandia, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
What’s the problem?
On October 30, 2008, Public Citizen’s Health Research Group (HRG) submitted a petition to the FDA requesting that GlaxoSmithKline’s Avandia be banned due to the drug’s serious side effects, including some newly found cases of liver failure.
According to the petition:
“Our petition is based on [Avandia]’s multiple, serious risks, including one just documented by our new analysis of 14 cases of liver failure, of which 12 resulted in death.”
In the document, Public Citizen compared Avandia to Rezulin (troglitazone) when it comes to the risk from drug-induced liver failure, as is seen from the following excerpt from the petition:
“[Rezulin], a thiozolidinedione similar in structure to [Avandia], was approved for marketing by the FDA in March 1997, but was withdrawn from the market in March 2000 after 94 cases of [Rezulin]-induced liver failure, the majority of which were fatal, were reported. Although the premarketing signal for hepatotoxicity with [Avandia] was not as strong as the signal with [Rezulin], one of the most hepatotoxic drugs ever approved by the FDA, several cases of [Avandia]-induced hepatotoxicity have been reported in the literature, and many more via the FDA Adverse Event Reporting System (AERS).
Taking the cases of liver failure together with “the accompanying lack of evidence of any clinical benefit” over other diabetes medications, Public Citizen said the time has come for the FDA to order an immediate Avandia recall.
Contact an Avandia Lawyer
Schmidt & Clark, LLP is currently accepting new Avandia cases throughout the entire United States. Our Defective Drug Litigation Group consists of highly experienced trial lawyers that focus exclusively on the representation of plaintiffs in Avandia lawsuits.
Again, if you or a loved one has suffered liver failure or other adverse side effects as a result of taking Avandia, you should contact our law firm immediately by using the form below. You may be entitled to compensation and we can help.