On September 23rd, the FDA announced severe restrictions to be placed on GlaxoSmithKline’s controversial diabetes drug Avandia. These restrictions make Avandia an option only for patients with Type 2 diabetes who cannot use other medications to control their symptoms.
The European Medicines Agency announced the same day that it was taking Avandia off the European market completely. The FDA and international regulators have been examining the safety record of Avandia since a 2007 study highlighted serious risk of heart attacks and heart disease in patients taking the drug.
An FDA advisory panel voted 20-12 in July of this year to allow Avandia to remain on the market with labeling requirements. Questions have been raised about conflicts of interest on this Avandia panel after it was reported that members of that panel may have had improper or undisclosed financial relationships with Avandia’s manufacturer, GlaxoSmithKline.
The 2007 study by Dr. Steven Nissen of the Cleveland Clinic showed that diabetes patients on Avandia were significantly more likely to experience:
That research was followed up by further studies showing similar risk profiles, including one from June, 2010 by FDA scientist Dr. David Graham estimating that Avandia had caused 100,000 cases of heart attack, stroke, heart failure, and death.
The FDA’s September decision to restrict Avandia is akin to a defective drug recall, though it does not completely remove Avandia from the prescription drug market. While not a full defective drug recall, the decision does lend credibility to potential Avandia drug injury lawsuits. This could add to the millions of dollars GlaxoSmithKline has already paid this year in defective drug injury compensation.
If you or a loved one has had a heart attack or stroke after taking Avandia or has taken another defective drug and been harmed, please contact the pharmaceutical litigation attorneys at a personal injury law firm near you.