FDA panel votes to loosen restrictions on Avandia despite heart attack risk

images2 100x1001 FDA panel votes to loosen restrictions on Avandia despite heart attack riskAn advisory panel to the Food and Drug Administration (FDA) voted to recommend that the severe restrictions the agency placed on the type 2 diabetes drug Avandia be loosened. The vote was far from unanimous, with five members voting to keep the tight restrictions on Avandia and one member (the consumer representative) calling for the withdrawal of the drug.

Avandia, also known as rosiglitazone, was a top-selling diabetes medication until, in 2010, the FDA placed severe restrictions on the medication based on studies that showed the people who took the medication were at greater risk of dying from a heart attack. Now only about 3,000 prescriptions for Avandia are written each year.

GlaxoSmithKline (GSK) has long fought claims that its blockbuster diabetes drug was deadly, claiming fault with the analysis of data from clinical trials. This led to the agency agreeing to take a fresh look at new analyses on cardiac and death risk with Avandia. The majority (13) voted not to completely lift the tight restrictions on Avandia, but loosen them slightly to allow more prescriptions to be written.

Steve Nissen, a panel member who in 2010 helped ignite the Avandia controversy and who was not invited to participate in this latest vote, issued a statement:

Little practical impact. Despite maximal efforts by FDA to convince the panel to remove restrictions, the majority voted to continue restricted access. If FDA loosens the requirements, a few additional patients may receive the drug, but effectively, Avandia is gone, which is a good thing.

We have three sources of data regarding Avandia. The meta-analyses, include FDA’s, show an increased risk of heart attack ranging from 40 to 80 percent. The observational data virtually all show an increased hazard for MI. The outlier is RECORD and it was a fatally flawed trial, completely unblinded to patients, physicians and GSK.

I’m relieved that Avandia will remain restricted and continue to doubt the wisdom of spending taxpayer dollars to try to resurrect this drug.

The FDA is not required to follow the recommendations of its advisory panels, but it usually does.

Other type 2 diabetes drugs have come under fire by the FDA in recent years regarding safety concerns. In 2011, the agency issued warnings that Actos, a diabetes drug in the same class of medications as Avandia, increased the risk for bladder cancer.

Source: Forbes