FDA pressures Pfizer
by Brian Turner
The U.S. food and Drug Administration today asked Pfizer to remove Bextra, an arthritis drug, from the market because the risks of its use outweigh its benefits.
The FDA also asked Pfizer to put a safety warning on Celebrex.
Both Bextra and Celebrex are members of a class of drugs called cox-inhibitors that are suspected of causing an increased risk of heart attack and stroke in patients using them.
In March, the FDA had allowed both drugs to stay on the market, pending review, as long as they came with warnings about their use.
Pfizer, the world’s largest drug manufacturer, agreed to suspend sales of Bextra in the U.S. until further discussions with the FDA could clarify matters.
Earlier, Pfizer had insisted that its drugs were safe.
The FDA also said Thursday that it would review proposals by another drug company, Merck, to return its drug Vioxx, another cox-inhibitor, to the market.
The agency also asked all drug companies producing cox-2 drugs to put risk warnings on their labels. This news took shares of Pfizer down 1.6 percent in early trading Thursday. Merck was down as well.
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