Bextra® Safety
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Bextra® safety concerns have been mounting ever since the recall of a similar drug. Vioxx is a prescription medication, similar to Bextra® in form and function, which was recalled from the market in September 2003 after studies revealed that patients taking this pain killer for eighteen months were twice as likely to suffer from heart attack or stroke as the general population. Bextra® safety and the safety of all similar drugs has become a major concern for federal drug regulators, physicians, and patients.
Bextra® is one drug in the class of prescription medications known as COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs). Bextra® was approved by the FDA in 2001 to treat the severe pain associated with osteoarthritis, rheumatoid arthritis, menstrual cramps, and a number of other chronic pain conditions. Originally these drugs were designed to provide effective pain relief without the harmful gastrointestinal side effects associated with original NSAIDs like naproxen and ibuprofen. In terms of gastrointestinal risks, Bextra® safety was touted as being superior to the safety of alternative treatments.
Following the Vioxx recall, major concern about cardiovascular Bextra® safety prompted Pfizer, Bextra®'s maker, to announce immediate plans to conduct further Bextra® safety studies to determine long term cardiovascular effects of taking Bextra®. Pfizer repeatedly ensured the public that Bextra® safety was not a concern and that cardiovascular risks were unique to Vioxx.
On November 9, 2004, the American Heart Association's annual meeting convened in New Orleans. During this conference a leading heart researcher disclosed information about Bextra® safety in terms of cardiovascular risks. This expert cited a recent study that indicated patients who take Bextra® after cardiac bypass surgery are at an increased risk of suffering from cardiovascular complications, as compared to patients who had not taken Bextra® after undergoing a similar surgical procedure. Pfizer had acknowledged this risk in patient product packaging information prior to this announcement, but it was quick to refute this new evidence once it was reported by heart health experts. Pfizer issued statements claiming that this Bextra® safety information was unsubstantiated and inconclusive. While promising to continue Bextra® safety research, the pharmaceutical giant is not currently considering a recall of this drug due to Bextra® safety concerns.
In addition to potential cardiovascular risks, there are other serious Bextra® safety issues that have been well established for some time. Bextra® safety is compromised in patients who are taking other medications such as aspirin, anti-convulsants, warfarin, and oral contraceptives. The most serious well established Bextra® safety risk is the potential development of serious skin diseases. Stevens-Johnson syndrome and toxic epidermal necrolysis are two serious skin conditions that are caused by Bextra® use. The FDA has urged Pfizer to include a black box Bextra® safety warning to communicate these serious risks to patients and physicians. To date, the company has not issued any such Bextra® safety warning.
Please contact a Bextra® Lawyer if you would like more information on Bextra® heart warnings and your legal rights and options.
