Avandia 2/2011 Update: Label Changes in Store

Image by insearchofbalance via FlickrGSK will be updating the labeling of Avandia. It will  now include safety restrictions ordered by federal health authorities because of the drug's links to heart attack.

The FDA made the changes in the fall of 2010, as part of several agenda items regarding the diabetes pill. The European Union has banned the drug.

The new U.S. label will explain that Avandia is only intended for patients who cannot control their blood sugar with any of the other diabetes medications on the market. Patients who are currently on the drug can continue taking it after consulting with their doctor.

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Meridia and Heart Problems?

The New England Journal of Medicine (NEJM) has found that among nearly 10,000 overweight or obese patients, those who used Meridia had a 16% greater risk of having a heart attack or stroke over an average 3.4 years than patients taking a placebo. None of the events were fatal, but the finding was especially worrisome since the trial included only patients with a previous history of heart disease or diabetes, or both, which put them at high risk of a second event. Being overweight, they were also already at a higher risk of heart-related health problems.


A study was commissioned by the European Union's European Medical Agency, after initial studies of Meridia users, conducted prior to 2002, found that the drug raised blood pressure and pulse rates, both well known risk factors for heart disease. When Meridia, which suppresses appetite by regulating the brain chemicals serotonin and norepinephrine, was approved for use in the U.S. in 1997, the FDA included a warning about these risks on the label.

Read more: http://www.time.com/time/health/article/0,8599,2015619,00.html#ixzz0yKq0tzz1

Read more: http://www.time.com/time/health/article/0,8599,2015619,00.html#ixzz0yKprSrjQ

Florida/Georgia Avandia News: Restrict, but don't Recall Avandia

Avandia survives another round of FDA meetings. An FDA panel  panel took six votes on a variety of issues, but its most important came near the end of the meeting when asked what the FDA should do. Sales should be restricted and the warnings on its label enhanced; 7 voted only to support enhanced warnings on the drug’s label; and 3 voted that the drug should continue to be sold with its present warnings unchanged. One member abstained, and no one voted for a final option, to weaken the label’s present heart warnings.


Avandia, which was once the biggest-selling diabetes medicine in the world, saw its sales abruptly decline in 2007 after a study by Dr. Steven Nissen, a Cleveland Clinic cardiologist, found that it increased the risk of heart attacks. An advisory committee in 2007 decided that Avandia did increase heart risks but voted to keep it on the market.

Many of the same experts who decided to keep the drug on the market in 2007 voted Wednesday that it should be withdrawn or restricted. Those restrictions could mean that patients would have to apply for special permission to use the drug.

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