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Prescribe Celebrex and Bextra with caution, says FDA

Ambulatory Surgery Reimbursement Update, December 28, 2004

The Food and Drug Administration (FDA) has recommended that doctors take care to limit the number of prescriptions they write for the painkilling drugs Celebrex and Bextra, citing recent studies that have linked the drugs to increased risks of heart attack and strokes.

Last Thursday, according to The New York Times, the FDA offered the warning to all physicians, particularly those who may be accustomed to prescribing the drugs to patients who suffer from arthritis, post-cardiac surgery pain or other types of pain. The FDA did not ban the use of the two drugs on any classification of patients, trusting instead in the judgement of prescribing physicians.

In the wake of a similar drug, Vioxx, being pulled from the market in September due to studies that showed it could double the risk of heart attack and stroke in longtime users, concerns grew over Celebrex and Bextra. Pfizer, the makers of Celebrex and Bextra, did release one study in November that showed Bextra also more than doubled the incidence of heart attack and stroke among patients who had recently undergone heart surgery, but kept the drugs on the market because no other surveys backed up those findings.

The FDA has said they will examine more studies conducted recently on Bextra and Celebrex, and from their findings decide whether stronger action should be taken. The FDA expects to know more in February, after a group of independent experts in the field gather to compare notes and review the existing data.

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