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Pfizer Inc., the world''s biggest drugmaker, will warn doctors of the elevated risk of blood clots, heart attacks and strokes its painkiller Bextra has been linked to when taken by cardiac-surgery patients.
The drug company will also highlight existing warnings of a potentially fatal skin reaction to Bextra with a black box, the FDA''s strongest drug warning short of a withdrawal. The FDA said in its statement that the 1,500 patient study found those treated with Bextra were more likely to have heart attacks, strokes and blood clots in their legs and lungs than those who did not take the drug.
The stronger warning label prompted Sen. Charles Grassley, the head of the Senate Finance Committee, to ask the FDA and Pfizer for records related to Bextra. Public Citizen director, Sidney Wolfe, asked in a telephone interview why a black box warning on the heart risk was not already on Bextra labeling saying, “we''re back in some ways to where we were with Vioxx four years ago.”
Bextra belongs to the same class of COX-2 inhibitor drugs as recently recalled Vioxx, which was removed from the market after finding an increased risk of heart attack and stroke among patients using the drug for 18 months or longer. The withdrawal of Vioxx is being investigated by Grassley''s committee, and concern over the two remaining COX-2 drugs, Pfizer''s Bextra and Celebrex, have prompted a stronger review of the two drugs.
The FDA will hold a meeting next year to review Bextra and Celebrex.
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