Pharmaceutical Injuries - Celebrex

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Celebrex (generic name: celecoxib) have been linked to an increased risk of blood clots, heart attacks and strokes. Celebrex is used to treat arthritis. Celebrex is a COX-2 inhibitor, marketed by Pharmacia Corporation and Pfizer Inc. in the United States. The drug is prescribed for the treatment of osteoarthritis, adult rheumatoid arthritis, and the pain associated with menstrual cramping. Celebrex was the first of Pharmacia's COX-2 inhibitors. The FDA is asking two outside advisory committees if Celebrex and Bextra offer enough benefits to stay on the market, if any pain relievers need stronger warnings and what further research is needed. The advisers are due to meet from February 16, 2005 through February 18, 2005. Studies "strongly suggest" the entire class of drugs called COX-2 inhibitors elevates the chances of cardiovascular problems, Dr. Ned Braunstein, senior director of Merck Research Laboratories, told the panel of FDA advisers.

A study from the Cleveland Clinic appeared in the Journal of the American Medical Association and was based on an analysis of previous clinical trials. Celebrex and Vioxx are projected to produce U.S. sales greater than $6 billion this year. In a study of more than 8,000 patients that compared the COX-2 inhibitor rofecoxib (Vioxx) with the traditional NSAID naproxen, the risk of cardiovascular problems, including heart attack, chest pain related to heart disease, stroke, sudden death and blood clots, was more than two times higher in the rofecoxib group than in the naproxen group.

Merck voluntarily withdrew Vioxx in September after a study showed the drug doubled the risk of heart attack and stroke in patients who took it for at least 18 months. Since the Vioxx recall, questions have arisen about similar pain pills from Pfizer Inc., Celebrex and Bextra, as well as non-prescription drugs such as Naproxen (Aleve). All pain drugs in the class known as cox-2 inhibitors increase the risk of heart attacks and strokes, a top scientist told a US regulatory panel. Dr Garret Fitzgerald, a cox-2 expert and researcher at the University of Pennsylvania, said the body reacts in the same way to drugs including Merck's Vioxx and Pfizer's Celebrex and Bextra. Dr Fitzgerald said the drugs create an imbalance in the body's cardiovascular system that leads to an increased risk of heart attacks and strokes.

Celebrex FDA Alert
FDA Celebrex Information & Risks
Pfizer Celebrex Home Page
Celebrex Safety Information

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