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Subscribe To Our Syndicated NewsNew Study Reveals Celebrex Increases Heart Attack Risks
March 2, 2006
New studies conducted by New Zealand researchers show Pfizer's painkiller, Celebrex, increases the risk of heart attacks in patients and is not any safer than similar medications that have been pulled from the market.
Celebrex is part of the same class of Cox-2 inhibitors as Bextra and Merck's Vioxx , which were pulled from the market after studies showed the significant increase in cardiovascular risks with the use of the drugs.
However, in 2005, the Food and Drug Administration concluded that the benefits of Celebrex outweighed the risks, thus making it the only remaining Cox-2 inhibitor available on the market. The FDA did require Celebrex to carry a "black box" warning alerting consumers of the heightened risk of heart attacks.
But the new study, which used data from six previous clinical trials on Celebrex involving more than 12,000 users, employed a mathematical review called meta-analyses to provide an overall answer to the ongoing Celebrex controversy.
Researchers compared Celebrex's cardiovascular risks with those of a placebo drug and with a class of common painkillers, which have also been associated with heart attacks and stokes.
The study, published in the Journal of the Royal Society of Medicine, found that the use of Celebrex more than doubled the risk of heart attacks compared to a placebo drug and had a 1.88-fold increase in comparison with other painkillers.
The paper concluded, "this finding would suggest that the preferential risk/benefit assessment afforded to celecoxib (Celebrex's scientific name) over other Cox-2 inhibitors by the FDA may not be supported by the currently available evidence."
According to Pfizer, the information in the new study was given to the FDA last year when they made their decision to keep the drug on the market. "It's not new data. It's data that the regulatory authorities have already looked at," said Gail Cawkwell, senior medical director of Pfizer's Cox-2 program.
Cawkwell also said that Pfizer plans to launch their own major study run by scientists at the Cleveland Clinic that will show whether or not Celebrex users have an increased rate of cardiovascular problems than people using other painkiller medications.
Contact us to learn more information about Celebrex or to speak with a qualified and experienced attorney.
