According to a report in the New York Times, patients taking Bextra® had more than double the risk of having a heart attack or stroke compared to those taking placebos. The study included 5,930 patients participating in 12 different clinical trials. Preliminary results show patients taking Bextra® reporting a heart attack or stroke 2.19 times more often than those taking placebo.
Bextra®, also known as valdecoxib, is a COX-2 inhibitor commonly prescribed for the relief of arthritis pain. With the recent withdrawal of the COX-2 inhibitor Vioxx® from the market this class of pharmaceuticals is coming under increased scrutiny.
Dr. Garrett A. FitzGerald, a cardiologist at the University of Pennsylvania, states that Bextra® "is a time bomb waiting to go off." The "magnitude of the signal with Bextra® is even higher than what we saw in Vioxx®." According to slides presented by Dr. FitzGerald at the American Heart Association's annual meeting, in the first study done on open heart surgery patients, the was risk was 3.5 times higher. In the second study presented the heart attack risk was 2.88 higher and in the third study presented it was 1.77 higher. According to Forbes.com Dr. Eric Topol believes that the heart surgery studies are "the real deal" and indicate a cardiovascular problem for Bextra®.
According to the Wall Street Journal, The analysis was based on 7,771 patients, including 5,930 patients taking Bextra® and 1,841 taking placebo. Out of those who took Bextra® there were a total of 45 heart attacks and strokes and only 7 in the group taking placebo. When only heart attacks are counted, the numbers are 16 among those taking Bextra® and only 2 among those taking placebo.
The Food and Drug Administration is also in discussions with Pfizer about revising the label for Bextra®. According to Pfizer Inc. Bextra® can cause a possibly life-threatening reaction called Stevens-Johnson Syndrome. Stevens-Johnson Syndrome causes the skin, mouth and eyes to become horribly blistered. The so-called "black-box warning" could severely impair Pfizer's ability to market Bextra®.
Learn more about Stevens-Johnson Syndrome.
Celebrex®, also from Pfizer, can also be a cause of Stevens-Johnson Syndrome, but according to Pfizer it has been more common with patients taking Bextra®. In most cases the symptoms develop within the first two weeks of taking the drug.
A letter was sent to healthcare professionals on October 15th by Pfizer warning of the risk of Stevens-Johnson Syndrome developing in patients taking Bextra®. Also included in this letter was a warning about increase risk of heart attack or stroke in high-risk patients taking Bextra®.
If you believe that you or a relative were injured by taking Bextra® please use the form below to contact our law firm.
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