Glaxo Dismisses Avandia Liver Failure Risk

Following a petition filed last week by the consumer advocacy group Public Citizen, which called for an Avandia recall due to a risk of liver failure and other life-threatening injuries, GlaxoSmithKline has issued a statement dismissing the claim that there are liver safety issue caused by side effects of Avandia.

Public Citizen filed the petition calling for the ban of Avandia after identifying at least 14 cases of liver failure, including 12 deaths, associated with the drug in the FDA Adverse Event Report System. They also pointed to prior studies, which have linked the use of Avandia with an increased risk of heart attacks, heart related death and other potentially life-threatening injuries.

GlaxoSmithKline received approval from the FDA to begin marketing Avandia (rosiglitazone) in 1999 for treatment of type 2 diabetes, and it quickly grew into a worldwide best-seller, with annual sales exceeding $2 billion.

Avandia prescriptions have been falling steadily since May 2007, when a meta-analysis was published in the New England Journal of Medicine suggesting that Avandia increases the risk of heart attacks and heart related deaths.

Since that time, the FDA has added a black box warning to the drug about the potential Avandia heart attack risk, the American Diabetes Association has dropped Avandia from their list of recommended treatments for type 2 diabetes and many experts have questioned the continued use of the Avandia.

Glaxo has been fighting to defend their once-blockbuster drug, insisting that it remain on the market. Despite the mounting evidence that the risks of Avandia outweigh the benefits, Glaxo issued a statement on October 30, 2008, reaffirming their support of the safety and efficacy of Avandia, and indicating that the current warning label is sufficient.

“On a continual basis, an external Hepatic Safety Board reviews any adverse event report received by GSK of liver failure, liver related deaths and liver transplants for possible relationships to AVANDIA,” wrote the drug maker in the press release. “As recently as July 2008, this panel of experts continued to endorse a favorable hepatic safety profile for Avandia.”

Following the publication of the May 2007 study by the New England Journal of Medicine about the Avandia heart risks, Glaxo made similar statements to the media calling the concerns an “overreaction”.

A few months later, reports surfaced about actions Glaxo took to silence critics who voiced concerns about the heart effects of Avandia, including attempts to intimidate and pressure independent scientists who spoke out.

According to a November 2007 report from the U.S. Senate Finance Committee, Dr. John Buse has indicated that Glaxo pressured him to retract statements he made as early as 1999 about potential heart risks associated with Avandia.

Glaxo currently faces hundreds of Avandia lawsuits filed by users of the type 2 diabetes drug who have suffered heart attacks, liver failure, congestive heart failure, vision loss, bone fractures and death.