Avandia Injury Suits Could Cost GSK $6 Billion
*** 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).
What’s the problem?
Financial analysts estimate that GlaxoSmithKline could face up to $6 Billion in liability as a result of Avandia injury lawsuits.
UBS analyst Gbola Amusa issued the estimate in response to concerns caused by the release of a U.S. Senate Committee report in March 2010 about the problems with Avandia. Since then, the FDA has indicated that the agency is continuing to review the safety of the drug, which many have said should result in an Avandia recall.
Amusa indicates that since the drug only contributes about 1% to GSK’s sales, the primary concern for the drugmaker stems from the liability it may face from more than 13,000 Avandia lawsuits that have been filed to date. The range of liability is currently estimated to fall between $1 billion and $6 billion, with the cost to the drugmaker possibly hitting the top end of the range if Avandia is removed from the market.
The suits allege that GSK failed to adequately warn users about the increased risk of serious and potentially life-threatening injuries, such as hear attack, stroke, congestive heart failure, liver failure, bone fractures, macular edema (vision loss), and death. Some experts have estimated that Avandia caused between 60,000 and 200,000 heart attacks and deaths due to cardiovascular problems in the U.S. from 1996 to 2006.