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Subscribe To Our Syndicated NewsBextra recall leaves threat of litigation
- April 7, 2005
Pfizer Inc. has agreed to suspend the sales and marketing of its COX-2 inhibitor painkiller Bextra at the request of U.S. and European drug regulators.
Bextra belongs to a controversial class of drugs known as COX-2 inhibitors. The group of drugs includes Merck & Co.'s recalled drug Vioxx, as well as Pfizer's blockbuster drug Celebrex. Last September, Merck recalled Vioxx after a company-funded study showed Vioxx patients had more than double the risk of heart attack and stroke compared to those on a placebo, setting off questions if the Vioxx effects were indicative of a class wide effect.
Pfizer immediately defended its products, saying the Vioxx effects were not evident among Bextra and Celebrex users. In December, the FDA had called on doctors to limit prescribing Bextra and Celebrex in light of evidence that the drugs may increase the risk of heart attack and stroke.
In conclusion to a three-day meeting of a panel of doctors and scientists in February, the advisory panel recommended Bextra and Celebrex remain on the market. The panel also added that Vioxx was safe enough to return to the U.S. market, though most members felt all three drugs should carry black box warnings. Although the FDA is not required to take the advice of its advisory committee, the agency usually does.
Going against the panel, the FDA said Bextra's risks outweigh its benefits and should be removed from the market. The FDA also asked Pfizer to add the government's strictest warning to Celebrex, according to an e-mailed statement today. Manufacturers of related over-the-counter painkillers, such as aspirin and ibuprofen, will also have to carry warnings about the risks of cardiovascular events and gastrointestinal bleeding.
Last year, Bextra generated $1.29 billion in sales for Pfizer, while Celebrex brought in $3.3 billion. Because Pfizer defended Bextra, claiming there were no side effects, there could be a threat of litigation in response to the drug's withdrawal from the market. On top of the cardiovascular risks the entire drug class is associated to, Bextra also carries a risk of a serious skin reaction called Stevens Johnson, which is indicated in a black box warning the drug already carried.For more information on the bextra recall, please contact us.
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