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In 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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