Avandia

Consumers of the diabetes drug Avandia, may be at risk of heart failure, a Cleveland Clinic cardiologist says in a report published by the New England Journal of Medicine.

Avandia, which is manufactured by GlaxoSmithKline and is generically known as Rosigilitazone, has been associated with an increased risk of myocardial ischemia, which causes reduced blood supply to the heart muscle. Those taking the drug, which is commonly used by Type 2 diabetics, have, according to the Cleveland Clinic study, a higher risk of suffering a heart attack. The drug has also been reportedly linked to hundreds of deaths. (http://www.nytimes.com/2010/02/20/health/policy/20avandia.html).

These possible devastating effects led the Food and Drug Administration (FDA) in 2007 to issue a "black box" warning about the safety risks posed by the medicine. However, despite numerous warnings and studies associating Avandia to heart failure, the drug continues to be one of the most widely used oral diabetes treatments with 2009 sales of 1.2 billion. This continuous distribution is, according to a recent Senate Finance Committee Avandia report, causing hundreds of unnecessary heart failures each month.

The report, developed over the last two years by committee investigators who reviewed more than 250,000 pages of documents provided by GlaxoSmithKline, the FDA, and several research institutes, proposes that the drug be removed from the market since the FDA itself has estimated that the drug caused more than 80,000 excess heart attacks between 1999 and 2007. The report additionally faults the manufacturer of unnecessarily delaying the issuance of warnings and of working to keep from the public the risks imposed by the drug.

"Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them," said U.S. Senator Max Baucus, who chairs the Senate Finance Committee. "Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust."

The FDA may also be at fault for failing to protect those suffering from diabetes by continuing to allow the distribution of the dangerous drug, Senator Baucus said.

"The FDA has been too cozy with drug makers and has been regularly outmaneuvered by companies that have a financial interest in downplaying or under-exploring potential safety risks."

Quick Facts:

Generic Name:

Rosigilitazone.

Date Approved:

May 25, 1999.

Approved Uses:

Type 2 diabetes.

Serious Side Effects:

Death

Stroke

Heart failure

Important Links:

Senate Finance Committee Avandia Report:

http://finance.senate.gov/newsroom/chairman/release/?id=bc56b552-efc5-4706-968d-f7032d5cd2e4

Cleveland Clinic Study published on the New England Journal of Medicine.

http://content.nejm.org/cgi/content/full/NEJMoa072761).

Food and Drug Administration Issues Warning on effects of drug Avandia:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm109026.htm