Avandia: "Substantial" New Cases Since the Summer

Philadelphia, PAA Type 2 diabetes drug that was once the best-selling drug of its kind in the world continues to present legal and financial issues for its manufacturer. GlaxoSmithKline (GSK) announced earlier this week that it would be taking a $3.4 billion charge with regard to Avandia in the wake of government investigations and lawsuits.

Meanwhile, The New York Times revealed on January 17 that four months after announcing severe limits on the use of Avandia in the US in an effort to stem Avandia risks, the US Food and Drug Administration (FDA) has yet to implement those restrictions.

The massive charge, which is expected to exceed GSK's quarterly profits, is on top of a $2.36 billion charge that GSK took last summer to settle about two-thirds of the existing Avandia lawsuits. That effort took care of about 10,000 claims, with 3,000 remaining.

However, in a statement to the London Stock Exchange, GSK revealed "substantial" new claims that have come in since that time.

The news came as no surprise to Dr. Steven Nissen, the noted cardiologist and chair of cardiovascular medicine at the Cleveland Clinic. He said in an e-mail to The New York Times on January 17 that "millions of patients were exposed to Avandia during 11 years on the market, resulting in 50,000 or more excess heart attacks," he said. "Most of these events occurred during a period of time when GlaxoSmithKline was aware that the company's own research demonstrated a hazard for the drug, but they failed to warn physicians or patients."

Nissen was responsible for blowing the whistle on Avandia in 2007, publishing research that revealed a 43 percent increased risk in Avandia heart attack. The European Medicines Agency has since banned Avandia outright. However, the FDA took a more cautious approach in spite of the substantial Avandia risks. Patients currently taking Avandia may continue to do so in concert with the wishes of the patient and physician. However, new patients to Avandia will only be allowed access to Avandia provided they have been adequately informed as to Avandia risks—and only if the patient has tried every other available drug for Type 2 diabetes first.

The FDA has yet to implement those restrictions.

GSK, meanwhile, stands behind its drug and shows no signs of voluntarily pulling the drug from the market in spite of charging in excess of $6 billion against 2010 earnings to fund various legal cases in the US. In the meantime, those Type 2 diabetes patients still taking Avandia must remain aware of various Avandia side effects, including bone fractures and liver failure.