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drug_recall bextraIn late 2004, medical professionals and researchers nationwide issued a Bextra alert regarding the potential risk of serious Bextra side effects, including heart attack and stroke. This Bextra alert followed the recall of a similar medication called Vioxx. Vioxx was recalled in September 2004, when studies revealed that patients who took this prescription pain reliever were two times more likely to suffer a serious stroke or heart attack than people in the general population. Because Bextra is similar in form and function to Vioxx, a Bextra alert was issued, warning consumers that Bextra use may carry similar risks.
The Bextra alert was compounded by information regarding the safety of another similar drug called Celebrex. Though Celebrex was not pulled off the market, clinical studies found that patients taking this prescription pain reliever may also be at a much greater risk of suffering stroke or heart attack, especially when taking higher doses of this drug. This information was reported in December 2004, closely following the Vioxx recall.
Bextra, Celebrex, and Vioxx are the three most popular COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs) introduced on the US drug market in the late 1990s. These drugs act on a specific enzyme in order to relieve the pain associated with osteoarthritis, rheumatoid arthritis, primary dysmenorrhea, and other chronic pain conditions. Due to proliferating evidence that all COX-2 painkillers have inherent heart attack and stroke risks, the Bextra alert warns patients that Bextra use may carry similar risks.
Another major component of the Bextra alert is clinical trial evidence from studies conducted on Bextra patients. Two clinical studies have raised the level of the Bextra alert, as they have found direct evidence of increase heart attack and stroke risks for Bextra patients. These studies measured the effect of Bextra on patients who had recently undergone coronary artery bypass surgery. Research found that heart surgery patients taking Bextra were two times more likely to suffer stroke, heart attack, blood clots in the legs, blood clots in the lungs, and kidney failure compared to patients not taking Bextra.
Due to this direct evidence of Bextra side effects, the Bextra alert urges doctors to prescribe Bextra with great caution and suggests that alternative treatments be considered. Since this Bextra alert was first issued, the FDA has begun evaluating the risks associated with Bextra and all other drugs of its class. In addition to heart attack and stroke risks, another major component of the Bextra alert involves serious skin-related side effects. Bextra use has been shown to greatly increase a patient’s risk of suffering two serious skin conditions: Stevens-Johnson Syndrome and toxic epidermal necrolysis. The FDA is also looking into this piece of the Bextra warning in order to determine whether stronger warning labels should be added to Bextra product information.
If you have questions about the Bextra alert or have suffered injuries as a result of Bextra use, you may wish to contact a qualified and experienced attorney who can help determine your rights and options in a legal case.
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