Avandia tied to liver failure?

[cougarnurse]

Now this from Bloomberg: Bloomberg.com: Health Care

New evidence shows GlaxoSmithKline Plc's Avandia can cause death from liver failure, said an advocacy group seeking a U.S. ban of the diabetes drug already linked to heart complications.

The group, Public Citizen, said in a statement today it has identified 14 cases of Avandia-induced liver failure, including 12 deaths. The Washington, D.C.-based organization also said it has petitioned the Food and Drug Administration to withdraw its approval of the medicine. Glaxo said Avandia is safe when used as directed.

A May 2007 report in the New England Journal of Medicine cited a 43 percent increased risk of heart attacks in Avandia users, prompting U.S. and European regulators to strengthen warnings on its prescribing information. Worldwide sales of Avandia products fell 23 percent in the fiscal third quarter to 191 million pounds ($313 million), Glaxo said Oct. 22.

"The FDA has more than adequate legal authority to immediately start the process of removing this drug from the market in the U.S.,'' Public Citizen said in the petition. ``Failure to do so will represent a dangerous dereliction of the agency's responsibility.''


Glaxo considers the drug to be safe "for appropriate Type 2 diabetes patients, when used according to the label,'' said Mary Anne Rhyne, a spokeswoman for the London-based company, in an e- mail.

''We do not believe there is a connection between liver toxicity and this medicine,'' she said.

The FDA will review the petition and respond, said Rita Chappelle, an agency spokeswoman, in a telephone interview.

Glaxo, the U.K.'s biggest drugmaker, declined 19 pence, or 1.6 percent, to 1,147 pence at 12:35 p.m. New York time in London trading.

Public Citizen said that while it has encouraged patients to avoid the drug, 4.6 million prescriptions for Avandia were written in the past year. In addition to liver damage and a higher risk of heart attack, Avandia doubles the risk of heart failure and bone fractures and increases risks of anemia and vision loss, Public Citizen said.

Of course, there is this, too: Avandia and heart risks