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August 1, 2005
Pfizer Inc. announced it would be updating the label of its controversial painkiller Celebrex. The new labeling will include a prominent warning of possible cardiovascular events, including an increased risk of heart attacks.
Celebrex labeling will also reflect a new warning that the drug, like older painkillers, can cause serious ulcers and gastrointestinal bleeding. The black box warnings, the strongest FDA issued drug warnings, were decided upon in response to agency requests.
When Celebrex first emerged on the U.S. market, the drug was touted as being safer than traditional painkillers because it could treat pain with a much lower risk of stomach bleeding. A large clinical trial later showed Celebrex failed to prove it was significantly safer for the stomach than a standard painkiller.
In February, a federal advisory panel of doctors said Celebrex "significantly" raised the risk of heart problems and strokes, but the panel still recommended it remain on the market. Pfizer said the Celebrex package insert label recommends it be prescribed "at the lowest effective dose for the shortest duration."
Pfizer's similar arthritis drug, Bextra, was taken off the market in April. Safety concerns regarding Pfizer's Celebrex and Bextra increased when Merck & Co. recalled its competitor Vioxx last September. Vioxx was shown to double the risk of heart attacks and strokes.For more information on Celebrex, please contact us to confer with a Celebrex Lawyer and learn your legal rights and options.