$60 Million Avandia Settlement Reported

Philadelphia, PAReports indicate that GlaxoSmithKline has agreed to pay approximately $60 million to settle the first wave of lawsuits regarding Avandia side effects. The lawsuits alleged that patients were not warned about side effects linked to Avandia, including an increased risk of heart attack and stroke.

According to Bloomberg on 5/10/10, GlaxoSmithKline agreed to the settlement to end more than 700 Avandia lawsuits. The first Avandia trial in state court was set to begin in July. GlaxoSmithKline reportedly still faces almost 3,000 lawsuits regarding Avandia.

Avandia was approved for sale in 1999 and generated revenue of $3 billion in 2006, including sales of a combination drug that includes Avandia. Sales of the diabetes medication fell off, however, after a 2007 study published in the New England Journal of Medicine linked Avandia to a 43 percent increased risk of heart attacks.

The drug maker has not commented on the settlement. Bloomberg cited "people familiar with the accords" as its sources for announcing the settlement.

In March, analysts suggested GlaxoSmithKline could face up to $6 billion in liability related to Avandia.

A US Senate report released in February 2010 claimed GlaxoSmithKline knew about the potential for increased risk of heart attacks linked to Avandia but did not make that information public for years. GlaxoSmithKline denied those allegations. Following release of the Senate report, Connecticut Congresswoman Rosa DeLauro released a statement on her Web site calling for Avandia's removal from the market.

"I strongly urge the FDA to remove Avandia from the market until a truly independent, science-based advisory panel can evaluate the safety and effectiveness of the drug," said DeLauro. "It is reprehensible that many people might have suffered heart attacks or heart failure as a result of taking this drug, especially if a safer alternative exists."

Meanwhile, the US Food and Drug Administration (FDA) continues to review Avandia's safety prior to an advisory committee meeting in July. The Wall Street Journal reported on 4/19/10 that the FDA is considering halting the safety trial comparing Avandia and Actos, but has made no decision yet. The trial, called TIDE, has been criticized by some scientists as being unethical for putting study participants at risk of serious health problems.

GlaxoSmithKline and the study's main researcher say the TIDE trial is ethical and should continue.

Actos is manufactured by Takeda Pharmaceutical Co.