In April 2005, Pfizer withdrew Celebrex / Celecoxib from the market after the FDA asked the pharmaceutical maker to pull the painkiller because the risk of a serious cardiovascular event outweighed Bextra’s potential benefit. The FDA also asked Pfizer to include a black boxed warning, the most serious warning a medication can receive, in the Celebrex label. The government is asking manufacturers of all other prescription NSAIDs to revise their labels to include the same boxed warning highlighting the potential for increased risk of cardiovascular events and gastrointestinal bleeding with their use. With these implications, a Celebrex attorney is needed to asses any compensation.
A damaging report has Celebrex lawyers and attorneys preparing for Celebrex lawsuits. On December 17, 2004 pharmaceutical maker Pfizer announced that a government-sponsored study on Celebrex’s ability to prevent cancer had been halted after researchers discovered that Celebrex’s risk of causing a major cardiovascular event was two-and-a-half times greater than the risk for patients taking a placebo. In fact, according to Celebrex lawyers, the report’s findings indicate that Celebrex’s risk of heart attack and stroke are even greater than that posed by Vioxx. Vioxx was withdrawn from the market in September 2004 after a similar study linked the medication to an increased risk of serious cardiovascular events.
Celebrex is an arthritis relief drug manufactured jointly by Searle Pharmaceuticals and Pfizer Pharmaceuticals. The FDA approved the drug in 1999. According to the manufacturers, Celebrex has been prescribed millions of times since its approval and currently is the most frequently prescribed arthritis drug. Celebrex reduces joint pain and inflammation by regulating the COX-2 enzyme. The drug is also known by its generic name celecoxib.
The drug has been linked to several gastrointestinal disorders and at least ten deaths since its approval. In addition, a recent study sponsored by the drug’s manufacturer found that Celebrex may increase a patient’s risk of suffering a heart attack, stroke, or blood clot. The manufacturers and the FDA continue to stand by Celebrex’s safety. Searle maintains that “the drug is performing as expected.” A study conducted by a U.S. private health insurance group has confirmed fears that cox-2 inhibitors cause serious cardiovascular events. In February 2005, Wellpoint Inc. released a study that found Bextra, Celebrex and Vioxx increase the risk of heart attack or stroke in users. According to the research, the risk of heart attack was 53 percent higher than normal for patients taking Bextra, 19 percent higher for those taking Celebrex and 23 percent higher for patients taking Vioxx. The study reportedly found no increase in cardiovascular events in patients taking traditional anti-inflammatory medications.
Concluding three days of meetings reviewing the safety of cox-2 inhibitors, advisers told FDA officials in February 2005 that Celebrex, Bextra and Vioxx, while posing an increased risk for cardiovascular events, should stay on the market because the drugs’ benefits outweigh their potential dangerous side effects. The advisory panel voted 31-1 to keep Celebrex on the market, 17-13 to keep Bextra available to patients and favored Vioxx by a vote of 17-16. Vioxx is currently not for sale after being recalled in September 2004. The FDA does not have to follow the panel’s recommendations but generally does. See your doctor if you have concerns about the safety of Celebrex or if you have experienced serious side effects associated with the drug.
If you or a family member has been injured, abused or otherwise harmed, you should contact one of our California attorneys who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence filing suit.
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