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drug_recall bextraA Bextra injury is caused by the serious side effects associated with this medication. Bextra injury cases have received widespread attention since the recall of a similar drug called Vioxx and clinical evidence suggesting the inherent cardiovascular risks associated with all COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs). Bextra, developed by pharmaceutical giant Pfizer, was approved to treat chronic pain conditions such as arthritis in 2001. The FDA approval of this medication preceded mounting evidence that this COX-2 pain medication increased risk of Bextra injury.
A Pfizer-sponsored study, known as post-CABG, studied the efficiency of Bextra in treating patients who had recently undergone coronary artery bypass grafting. The results of this study suggested that patients taking Bextra after heart surgery were at a much greater risk of suffering a Bextra injury, compared to the study’s control group. In this clinical study, Bextra injury cases included such complications as stoke, blood clots in the legs, blood clots in the lungs, heart attack, heart failure, and renal dysfunction and failure. This study concluded that, for this patient population, the aforementioned Bextra injury risks are twice as high compared to other heart surgery patients.
A second trial was performed in much the same manner as the post-CABG study and produced similar Bextra injury results. This second study also found that patients were twice as likely to suffer a Bextra injury related to stroke, heart attack, blood clot and kidney complications. This study also found an increased risk of other types of Bextra injury including delayed surgical wound healing.
A third study was conducted to measure the efficiency of Bextra for pain relief in relation to a traditional NSAID called naproxen. This study also found an increased risk of Bextra injury. The CLASS study found that patients who were taking Bextra were more likely to experience edema (swelling and fluid build-up) and hypertension (high blood pressure) compared to those participants taking naproxen.
As a result of these Bextra injury studies and similar heart attack and stroke risks associated with other COX-2 selective pain medications, concerns about the safety of this medication have taken the spotlight in medical and government communities throughout the nation. Consumer advocacy groups, like Public Citizen, have strongly urged the FDA to pull Bextra off the market due to the high patient risk of suffering a Bextra injury. In 2005, the FDA made plans to review the nature and frequency of Bextra injury cases in order to determine if this drug should remain on the market.
In addition to heart attack and stroke Bextra injury risks, Bextra is also strongly associated with two severe skin conditions: Steven’s Johnson Syndrome and toxic epidermal necrolysis. The FDA is currently in negotiations over the inclusion of a Bextra injury warning label regarding these skin risks.
If you or a loved one is taking Bextra and has suffered a Bextra injury, you may wish to contact an experienced and qualified attorney in your area who can help determine your rights and options in a legal case.
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