Avandia Side Effects, Lawsuits Do Not Warrant FDA Recall

Over the past two days, the FDA advisory panel of 33 experts had discussed the Type-II diabetes medication Avandia, and whether or not it was necessary to invoke a recall due to possible health threats and serious side effects. The panel’s majority voted to allow the drug to remain on the market; however, both sides agreed that the drug will require stricter regulations and greater attention to side effects like heart attacks and strokes.

According to the International Diabetes Federation, the global health-care costs for diabetes in 2010 is $376 billion, and is expected to grow $114 billion more by 2030. Avandia alone earned $1.1 billion in revenue for 2009. The drug had been grossing higher until a FDA panel reviewed this drug in 2007. If Avandia had been pulled, the risks accompanying similar pharmaceutical will pique the attention of investors; when profitable, approved drugs like Avandia are forced off the market, Takeda (TKPHF), Eli Lilly (LLY, Fortune 500) and Novo Nordisk (NVO) will have to watch out for their diabetes drugs too.

The FDA agreed to regulate the questionable safety of this controversial drug. Avandia is known to increase the risk of heart disease for the user, but it is unknown if this increase is greater than the risk of taking Actos (different drug of same class).

Since its approval in 1999, Avandia was flagged along with Actos to be monitored for the heart problems caused in patients. In 2006, GlaxoSmithKline (GSK) reported on Avandia's safety to the FDA. Steven Nissen, a well-known cardiologist, found the report's data faulty. He published a paper in the New England Journal of Medicine stating that the risk of heart failure for patients taking Avandia was significantly greater than patients taking Actos.

After calling the first Avandia advisory panel in 2007, the FDA required only an explanation of the greater risk in heart failure, along with guidelines, on Avandia's packaging. This conclusion was questioned in 2009 when the FDA received more reports. Evidence of GSK withholding data of Avandia being more dangerous than Actos also emerged.

Joshua Sharfstein, FDA principal deputy commissioner, clarifies that the latest meeting addresses the proper measures for the medication's safety, not the company's appropriate actions. If the safety issues had led to an Avadia recall, GSK may have encountered further litigation. However, Avandia makes just over 2% of GSK's revenue, with its patent expiring in a year.

If you or a loved one has experienced serious side effects, a heart attack or other health complications from using Avandia, contact Newsome Law Firm (www.newsomelaw.com) and fill out a case evaluation form today. Our team of attorneys has experience specific to complications associated with prescription medication. Not only can they give you the legal guidance you need, they can help you get the compensation you deserve.