Questions about the Safety of Avandia

A study published in the prestigious New England Journal of Medicine found that the type 2 diabetes drug, Avandia, raised patients' risk of heart attack by as much as 43% and their risk of heart-disease related death up to 64%. This study looked at the data from 42 clinical trials. In addition to primarily being a diabetes drug, Avandia is sometimes give "off-label" to Alzheimer's patients.

The Food and Drug Administration issued a safety alert on Avandia on May 21, 2007. Click HERE to read this report which warned patients taking Avandia who are know to have a risk of heart disease to speak with their doctors to evaluate their treatment options. The FDA has called for a "black box" warning on the Avandia label and is evaluating a number of clinical studies to determine what action should be taken. (www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html)

The FDA approved the use of Avandia to control blood sugar levels in Type 2 diabetes in 1999. About one million Americans take Avandia today. At the time the FDA approved the drug, the agency's primary medical reviewer expressed concerns about a potential "deleterious long-term effect on the heart" and recommended a post-marketing study to investigate those concerns. The manufacturer conducted a post-marketing clinical trial, but it was not designed to assess whether Avandia patients were at higher risk for heart attacks.

Patients with type 2 diabetes are mostly in the risk pool since diabetes itself increases the risk of serious heart disease. The American Diabetes Association reports that two out of three diabetics die of heart disease or stroke. However, doctors' concerned about patients who may stop taking diabetes medicine are urging calm. Due to the risk factors of untreated diabetes, the FDA is warning patients not to stop taking their medication without first consulting their doctors. There is conflicting evidence. A large study of 30,000 HMO patients taking Avandia found no increase in heart attacks.

Avandia manufacturer GlaxoSmithKline submitted information to the FDA last year that was similar to the study's findings. Avandia is sometimes given "off-label" to Alzheimer's patients. "Off-label" refers to the common practice of giving drugs for a condition for which that drug has not been approved. The generic name of Avandia is rosiglitazone.

A number of Congressional hearing are planned to look into the FDA's approval process for this medicine.

Created June 26, 2007