More Avandia Lawsuits Settled

Philadelphia, PAReuters reported yesterday that GlaxoSmithKline has settled additional Avandia lawsuits. The lawsuits alleged that GlaxoSmithKline, the maker of Avandia, failed to adequately warn patients about the risk of serious side effects.

A GlaxoSmithKline spokesperson announced the settlement on June 1, 2010, but did not give further details. Terms of the settlement, which affects approximately 5,000 claimants, are confidential. The settled cases would have gone to court in Philadelphia this month.

In May 2009 GlaxoSmithKline reportedly settled approximately 700 lawsuits for around $60 million. Although analysts estimated Glaxo could pay up to $6 billion in damages related to Avandia, those estimates have now dropped to below $3 billion.

Reuters notes that the average damages paid to claimants in the first 700 settled cases was approximately $86,000. If GlaxoSmithKline were to pay that amount to every claimant involved in litigation against the company—reportedly around 13,000 in all—it would pay out just over $1 billion in damages.

Following this settlement, the next lawsuit scheduled for court will be seen in October.

GlaxoSmithKline continues to defend Avandia, saying it adequately warned doctors and patients about the drug's risks and that the drug is an important treatment option.

Avandia has been under fire since a study published in the New England Journal of Medicine in 2007 suggested a link between Avandia and an increased risk of heart attack.

A study, known as the TIDE (thiazolidinedione Intervention in Vitamin D Evaluation) trial, is currently underway to compare the safety of Avandia with that of rival drug Actos. However, critics argue that such a study is unethical because it puts patients on Avandia at unnecessary risk. Two sites where the study was being conducted reportedly pulled out due to a lack of suitable candidates.

GlaxoSmithKline argues that the study is being conducted ethically. The US Food and Drug Administration (FDA) will hold an advisory committee meeting in July to discuss Avandia. Some reports indicate the FDA is considering halting the trial, but no decision has been made yet.

A US Senate report released in February 2010 alleges GlaxoSmithKline knew about the risks associated with Avandia but did not make that information public in a timely manner.