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Bextra

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In 2005 Bextra, the other effective drug has been withdrawn from the U.S. market due to the increased risk of cardiovascular problems. Bextra, with its substitute Cox-2s and Vioxx, used to be recommended for osteoarthritis, menstrual cramps and adult pain management. Some of the side effects from Bextra are indigestion, abdominal pain, nausea, diarrhea, and headache, discolored, excess weight gain, jaundice, flu-like symptoms, excess bleeding and water retention. For Expert consultation on Bextra Lawsuit you can, take advice from Bextra Lawyer or Bextra Attorney in your area.

Bextra has been demonstrated to be associated with an increased risk of serious adverse CV events in two short-term trials in patients immediately post-operative from coronary artery bypass graft (CABG) surgery. Data are not available from long-term controlled clinical trials to evaluate the cardiovascular safety of Bextra following chronic use. FDA has concluded that it is reasonable to extrapolate the adverse CV risk information for Bextra from the short-term CABG trials to chronic use given the fact that other COX-2 selective NSAIDs have been shown in long-term controlled clinical trials to be associated with an increased risk of serious adverse CV events, and the well described risk of serious, and often life-threatening gastrointestinal bleeding.

Advantage of Bextra over other NSAIDs that might offset the concern about these serious skin risks, such as studies that show a GI safety benefit, better efficacy compared to other products, or efficacy in a setting of patients who are refractory to treatment with other products. Bextra Settlement is a sulfonamide and already carries a boxed warning in the package insert for serious and potentially life-threatening skin reaction. The reporting rate to FDA’s spontaneous reporting system for these serious skin reactions is significantly greater for Bextra than other COX-2 selective agents. The risk of these serious skin reactions in individual patients is unpredictable, occurring in patients with and without a history of sulfa allergy, and after both short- and long term use.

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