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drug_recall bextraA Bextra recall was issued on April 7, 2005 after the FDA requested that Pfizer suspend sales of its blockbuster pain killer. The FDA ordered the Bextra recall after regulators concluded that the potential risks of Bextra use far exceed its intended benefits. The decision to issue a Bextra recall comes after months of intense scrutiny over this drug’s safety.
Anticipation of a Bextra recall first began to gain momentum after the recall of a similar drug called Vioxx in September 2004. Both Vioxx and Bextra are prescription drugs in a class known as COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs). These drugs were originally developed and FDA-approved in the late 1990s to treat the pain associated with arthritis, menstrual cramps, and other pain conditions. Concern about the safety of these drugs peaked in late 2004 after studies found that Vioxx users were two times more likely to suffer a heart attack or stroke as compared to the general population.
After the Vioxx recall, companies, regulators, advisors, lawyers, doctors, and consumers began to turn their attention to a possible Bextra recall, in the event that similar findings were discovered about this drug. Pfizer continually maintained that a Bextra recall was not warranted because cardiovascular risks were unique to Vioxx. Less than two months later in November 2004 Pfizer released the results of a Bextra cardiovascular safety study. This clinical trial found that recovering heart surgery patients were two times more likely to suffer a serious adverse cardiovascular event if treated with Bextra.
Despite these findings, Pfizer refused to issue a Bextra recall, maintaining that their product was safe. Pfizer also failed to issue adequate warnings about other serious side effects that might warrant a Bextra recall. Pfizer has known for years that Bextra use has the potential to cause a serious adverse drug reaction known as Stevens Johnson syndrome. Stevens Johnson syndrome is an eruptive and inflammatory skin condition caused by Bextra. Bextra users have lost their lives as a result of this condition, yet Pfizer took no steps to adequately warn or protect consumers from these risks.
In 2002 the FDA asked Pfizer to include a black box warning on all Bextra information. A black box warning is the strongest warning the FDA can request short of ordering a Bextra recall. For more than two years Pfizer refused to comply with this FDA request to issue an adequate warning about serious Bextra safety concerns. The pharmaceutical giant failed to adequately acknowledge serious side effect risks through Bextra’s entire stay on the market. Up until the Bextra recall, Pfizer knowingly marketed a dangerous and defective drug, overestimating its benefits while negligently underreporting its risks.
In light of the Bextra recall, the FDA has also requested that stronger warnings be revised for all NSAIDs to indicate the increased cardiovascular and gastrointestinal risks associated with these drugs.
If you would like to learn more about your legal rights and options following the Bextra recall, you may wish to contact a qualified and experienced attorney who can protect and maximize your interests in a case in order to recover from your Bextra-related losses.
Bextra , the popular cox-2 inhibitor recalled by Pfizer, is the subject of another lawsuit.
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