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Bextra Recall

On April 7, 2005 the FDA ordered Pfizer to issue a Bextra recall due to significant concerns about the safety of their top-selling painkiller. The road to this Bextra recall has been traveled by FDA regulators, scientists, doctors, consumers, and the maker's of this painkiller since concern about Bextra safety came to the forefront of social awareness after the Vioxx recall in September 2004. Some would argue that a Bextra recall has been in the making since this drug was first approved by the FDA in November 2001.

Bextra is a COX-2 selective non-steroidal anti-inflammatory drug (NSAID) belonging to the same class of drugs as Vioxx, Celebrex, and others. These prescription drugs have been used to treat chronic pain conditions like arthritis and menstrual cramps since the late 1990s. Vioxx was recalled in September 2004 after studies concluded that taking this NSAID for more than eighteen months doubled a patient's risk of suffering a heart attack or stoke. Immediately after the Vioxx recall, the cardiovascular safety of all COX-2 NSAIDs came into question as experts and consumers began to anticipate a Bextra recall.

Expectations of a Bextra recall only grew after studies soon found similar cardiovascular risks for patients taking Bextra. In November 2004, Pfizer issued a statement about the results of a Bextra cardiovascular study. The post-CABG study was conducted to measure the effects of Bextra treatment in pain management for patients recovering from coronary artery bypass grafting. This study found that trial participants treated with Bextra were two times more likely to suffer a heart attack, blood clot, stroke, or other adverse cardiovascular/thromboembolic event than participants in the control group.

After the release of this Bextra side effect information, consumer groups, scientific experts and others began to urge Pfizer to issue a Bextra recall. Pfizer continually maintained that use of Bextra was safe and that the results of this clinical trial did not sufficiently warrant a Bextra recall.

The Bextra recall was finally ordered by the FDA after regulators concluded that the potentially fatal risks associated with Bextra far outweigh its intended benefits. The FDA singled out this NSAID for a Bextra recall because it gives no added benefits as a painkiller and is also associated with a serious and deadly skin condition called Stevens Johnson syndrome. Prior to the Bextra recall, Stevens Johnson syndrome claimed the lives of some Bextra users. In response to these risks the FDA requested that stronger warnings be added to Bextra labeling. Pfizer declined to cooperate with this FDA request for more than two years prior to the Bextra recall.

Pfizer has knowingly manufactured this dangerous and defective drug for years, negligently putting patients' health and lives at risk without proper warning. People who have been injured by Bextra side effects prior to the Bextra recall have the legal right to seek compensation for their losses through a Bextra lawsuit. If you are interested in learning more about the Bextra recall, please contact us to speak with a knowledgeable and experienced Bextra attorney to determine your legal rights and options.

Please contact a Bextra Recall Lawyer if you would like more information on your legal rights and options.

Contact a Bextra Recall Lawyer

More Bextra Resources

Bextra Consumer Information - Patient FAQ on Bextra, including side effects, warnings and drug information from the FDA.