Avandia studies place medication on edge of recall

June 29, 2010

Avandia studies place medication on edge of recall

AvandiaHeart Risk from Popular Diabetes Medication The diabetes medication Avandia by GlaxoSmithKline has been the subject of two studies that were released Monday. These studies show that the use of Avandia can cause serious heart risks. U.S. regulators will be weighing the information from these studies to decide whether to pull Avandia from the market.

An advisory panel meeting is scheduled to be held in two weeks to make a decision about Avandia. The safety question concerning Avandia arose three years ago, knocking the popular drug down the ladder from being GSK’s 2nd biggest drug.

In 2007 a study was performed , the results of that study have now be updated based on analysis of 56 clinical trials to show that Avandia increases the chance of a heart attack by 28 to 39 percent. Cleveland Clinic’s head of cardiology Dr. Steven Nissen is the lead author of the studies and an outspoken critic of Avandia.

“A drug that increases the risk of heart attack by a third or more in diabetics represents a huge public health burden,” Nissen says. He has stated that he believes the drug should be removed from the market.

Studies performed by GlaxoSmithKline have not shown the same heart risks, and the FDA has kept the drug on the market while the risks and dangers are being reviewed. In February the FDA announced that it was again reviewing the risks of Avandia and scheduled the advisory panel meeting for next month.

The agency and the panel will consider the findings of the studies as well as others including FDA analyses that have not yet been made public. The panel has a lot of impact on the FDA’s decision as the FDA usually follows a panel recommendation.

Options that the panel will discuss include keeping the drug on the market but issuing a warning, prescribinglimitations or a complete ban of all future sales of the drug.

GSK defends the medication saying that six randomized clinical trials, considered the gold standard for medical studies showed that Avandia did not increase the overall risk of heart attack, stroke or death.

In the event that Avandia is pulled off the market diabetics have as many as 12 different options for medications approved to lower blood sugar. However at the moment the FDA advises physicians and patients to continue using the medication until a decision is made.

Publisher: Salient News

2 comments on “Avandia studies place medication on edge of recall”


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