Pfizer Hit With Bextra Lawsuit
Pfizer also is negotiating with the Food and Drug Administration for a tougher label on Bextra, which has been linked to the rare skin rash called Stevens-Johnson Syndrome. The company said in a recent filing with the Securities and Exchange Commission that a revised Bextra label "likely will include the addition of a black-box" warning about the skin disease. The black box warning is the FDA's strongest warning. The current Bextra label alerts doctors and patients to this side-effect. This warning was inserted in 2002, a year after Bextra was approved by the FDA.
Ever since Merck pulled Vioxx from the market, Pfizer has released several studies showing no cardiovascular risk for Celebrex, its best-selling COX-2 drug. Pfizer recently said it would conduct tests assessing the long-term cardiovascular impact of Celebrex. Pfizer's stock lost 27 cents, or 1%, to $27.35, just above its 52-week low of $27.02- Loading Comments...
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