Pfizer halts sales of Bextra; FDA wants warnings on many painkillers
WASHINGTON – Pfizer Inc. reluctantly halted sales of its arthritis painkiller Bextra on Thursday after the Food and Drug Administration concluded it posed too many serious safety risks. It was the second major arthritis medication to be withdrawn in the past six months.
In addition to asking Pfizer to stop selling its $1.4 billion-a-year blockbuster, the FDA concluded that the entire class of anti-inflammatory painkillers carries a potentially increased risk of heart attack and stroke – and it told manufacturers to substantially toughen the safety warnings on almost all non-narcotic painkillers still on the market.
Prescription painkillers such as Celebrex and Mobic will remain available, but with the strongest safety warnings the FDA can require. The makers of nonprescription pain relievers such as Motrin and Aleve will be required to tell consumers more about their risks – warning them to take the pills only for the short periods recommended on the labels, usually no more than two weeks.