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drug_recall bextraBextra litigation concerns continue to mount as the Public Citizen consumer group urged the FDA to immediately ban Pfizer’s Bextra, as well as Pfizer’s similar drug Celebrex, from the market January 24, 2005.
The consumer group’s petition came after months of controversy that has surrounded the safety of COX-2 inhibitors, the class of drug to which Bextra belongs. Bextra is just one of three federally approved COX-2 inhibitor drugs used by millions worldwide as an arthritis painkiller and for other ailments. The two other drugs in the COX-2 class include Merck & Co.’s Vioxx, which was recalled in September 2004, and Celebrex.
After Vioxx’s recall, and potentially massive litigation issues as a result, Pfizer reassured the public of the safety of its two remaining drugs on the market. Safety concerns regarding cardiovascular effects among the entire class of drugs were raised, causing many experts and patients to question the risks of taking Bextra and Celebrex.
In mid-January 2005, new data linking Bextra to increased risks for heart attack and strokes suggested a danger among all COX-2 inhibitors did exist. Celebrex warnings had been issued just a month prior, linking its use also to an increase in cardiovascular events. Within months, a highly popular class of drugs that millions of people used was suddenly linked to life-threatening cardiovascular events, and confused patients began inquiring about Bextra litigation.
In an editorial on a study published in the January 2005 online issue of Circulation, researchers called for a strongly worded “black box” warning on all COX-2 inhibitors, warning of potential cardiovascular risks. Critics of the drugs, and individuals seeking Bextra litigation, did not believe a black box warning would be enough, considering the increasing amount of evidence showing deadly events.
In the Bextra study that was led by Dr. Garret FitzGerald of the University of Pennsylvania, researchers pooled data from two separate Pfizer-funded studies involving hundreds of heart patients having coronary artery bypass operations. The placebo-controlled studies compared the effects of Bextra to that of an unapproved, experimental form of the drug, called Dynastat, over a period of up to two weeks.
While the results of both studies were not statistically significant, when they were combined in meta-analysis, the numbers became significant, with a threefold increase of heart attack and stroke in patients taking Bextra compared to the patients on placebo. The study results only increased skepticism of the drug’s benefits outweighing the risks, and a greater chance of potentially damaging Bextra litigation emerging.
In Public Citizen’s Bextra and Celebrex petition, the group argued the COX-2 drugs, which were claimed to carry a smaller risk of gastrointestinal damage than older pain relievers like aspirin or ibuprofen, in fact have insignificant gastrointestinal benefits alongside elevated risk of heart attack. In 2004, 12.9 million prescriptions were filled in the U.S. alone for Bextra despite the 12-page petition stating, “if a drug offers no unique benefit compared to other drugs for treating the same problem (in this case arthritis and pain) but subjects patients to a unique risk, it must be removed from the market.”
If the consumer group’s petition for an immediate Bextra ban occurs, Pfizer Inc. could find themselves in financial and legal trouble for potential Bextra litigation a recall would likely accompany.
Bextra , the popular cox-2 inhibitor recalled by Pfizer, is the subject of another lawsuit.
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