|Civil suits begin as a result of adverse effects of Avandia. Source: Pharma Marketing Blog|
A wrongful death suit has been filed in California Superior Court against GlaxoSmithKline, SmithKline Beecham and McKesson, charging that Avandia, prescribed for type 2 diabetes, led to heart attacks, congestive heart failure and other fatal cardiovascular events in seven individuals.
The suit was filed on behalf of the victims' seven surviving spouses living in Los Angeles and Costa Mesa, Calif.
The suit contends that GlaxoSmithKline (GSK), SmithKline Beecham and McKesson knew that Avandia increased the risk of adverse cardiovascular events but failed to adequately warn patients, physicians or the general public.
In April, the FDA criticized GSK for failing to report post-marketing clinical data on Avandia to U.S. regulators. In 2005, GSK performed an analysis of multiple Avandia trials, but did not share the complete results with the FDA until August 2006. The results showed that patients consuming Avandia had a 31 percent increased risk of adverse cardiovascular events, such as heart attacks.
“Doctors needed to be warned of its side effects,” said plaintiff Kathleen Rhodes from Costa Mesa, whose husband died of a heart attack a little more than six months after starting Avandia in 2002.
Avandia received FDA approval for the treatment of type 2 diabetes in 1999. Since then, it has been prescribed to approximately six million people in the U.S. and was ranked as GSK’s second largest selling drug, with sales more than $2 billion in 2006.
In 2007, Steven E. Nissen, MD, a cardiologist with the Cleveland Clinic, and colleagues published a study in the New England Journal of Medicine which showed that individuals taking Avandia have a 43 percent higher risk of heart attack than those taking other diabetes medications or no medication at all.
Even after the trials that had been performed and Nissen’s study, the law firm claims that defendants still did nothing to adequately warn or remedy the dangers associated with taking Avandia.
“This is yet another example of a very broken FDA. The justice system remains the last line of defense for ordinary citizens," said Shawn Khorrami, one of the lawyers representing Rhodes.
However, the FDA is taking measures to rectify matters. In July, an FDA panel determined that pharmaceutical companies producing diabetes drugs or biologics with no cardiovascular safety signal during clinical trials will be required to submit long-term cardiovascular trial results or other evidence to rule out an unacceptable level of cardiovascular risk.