Is Avandia Worth the Risk?

Washington, DCThe alleged relationship between Avandia and heart attack remains a concern for Type 2 diabetes patients who, while pleased with Avandia's capacity for controlling their diabetes symptoms are nonetheless worried about various side effects associated with Avandia.

The concern over potential cardiovascular risks is well-known, thanks in part to the publication of a meta-analysis in the New England Journal of Medicine two years ago that raised the alarm bells with regard to the potential for a higher risk of heart attack and death from cardiovascular causes.

"Any [diabetes] drug that is worth anything needs to decrease the risk of cardiovascular disease," says Sidney Wolfe, editor of worstpills.org and director of the health research group at the consumer advocacy organization Public Citizen. "When a drug increases the risk of cardiovascular disease, it should be off the market. "It's a huge failure that the [US Food and Drug Administration (FDA)] has not taken it off the market." His comments were published in the July 7th, 2009 online edition of US News and World Report.

However, not all studies reach similar conclusions. The recently released RECORD study mirrored previous research that suggested Avandia appeared to increase the risk for heart failure. At the same time, the RECORD trial found that taking Avandia did not appear to increase risk for heart attack and death.

And comments by readers of US News and World Report appear divided. One gentleman from West Virginia acknowledged the potential for Avandia side effects, but after weighing the options has been using Avandia for several years with good results.

Another reader writes of a friend who suffered a heart attack after taking Avandia. The friend is suing the manufacturer.

"Patients with diabetes have a two-to-four-times greater risk of heart disease than their non-diabetic counterparts, and none of the currently approved antidiabetic therapies has been convincingly proven to reduce that risk," said Karen Riley, a spokesperson with the FDA.

GlaxoSmithKline, the manufacturer of Avandia, continues to stand behind their drug in spite of efforts to have it removed from the market. . "We think that it's been shown to be a safe and effective treatment for type 2 diabetes for the appropriate patient," says Mary Anne Rhyne, a GlaxoSmithKline spokesperson. The RECORD study "addresses some of the [previous] concern, and we feel like it reinforces its safety for long-term glucose control for diabetes patients."

GlaxoSmithKline reportedly sponsored the RECORD study.