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Avandia Back In The News Due To Recent Senate Report

If you’ve been reading the papers, reading news online or watching TV, you might have seen that the diabetes drug Avandia is being mentioned again. The information below, which is background on the drug, is from our main website.

The drug Avandia, manufactured by GlaxoSmithKline, is used to treat Type 2 diabetes by helping patients control their blood sugar levels. The drug has enjoyed phenomenal sales, with 60 million prescriptions written since 1999. However, if you have taken Avandia to control your diabetes, you should be aware this best-selling drug has been linked to serious, life-threatening side effects.

In May 2007, a New England Journal of Medicine study found that Avandia increased the risk of heart attacks by 43 percent. Two months later, an FDA panel acknowledged the elevated risk of heart attacks from the drug but decided to keep it on the market with a “black box” warning. Diabetics who have mild heart disease or problems with their kidneys are at an elevated risk of developing congestive heart failure.

Heart problems are not the only serious side effect from Avandia. Experiments by a Salk Institute researcher found that the diabetes drug actually promoted osteoporosis by slowing bone growth while also speeding up bone loss. That finding reinforced clinical studies that showed an increased risk of bone fractures among patients who took Avandia.

One of the most serious health effects associated with Avandia is the onset of primary pulmonary hypertension, or PPH. This is a rare condition that causes the narrowing of blood vessels and results in high blood pressure. PPH is a precursor to heart failure, and this risk is highest in patients taking insulin or medicines called nitrates. Patients who develop PPH face these dire consequences:

– Shortness of breath
– Dizziness
– Fainting or loss of consciousness
– Heart failure
– Death


The reason Avandia is back in the news is because of a recent Senate report. After a two year inquiry, which included researchers’ studies of Avandia, internal GlaxoSmithKline documents and FDA documents, the report said that GlaxoSmithKline knew of the heart attack risks before the evidence became public. The report also questioned the FDA why it allowed a clinical trial of the drug after they had estimated over 80,000 heart attacks were caused by Avandia between 1999 and 2007. The full Senate report can be viewed here.

FROM THE SENATE REPORT:

“Had GSK considered Avandia’s potential increased cardiovascular risk more seriously when the issue was first raised in 1999 … some of these heart attacks may have been avoided”

“There is strong evidence that rosiglitazone [Avandia] confers an increased risk of [heart attacks] and heart failure compared to pioglitazone [rival drug on market].” They concluded and trials comparing the two would be “unethical and exploitive.”

“GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.”

RECENT AVANDIA NEWS ARTICLES:
-Senate report: Avandia maker knew of cardiac risks By BARBARA ORTUTAY
Senate report links diabetes drug Avandia to heart attacks CNN
Senate report ties GlaxoSmithKline diabetes drug Avandia to heart attack risks WASHINGTON POST

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