F.D.A. Urges Doctors to Limit Prescriptions for Two Painkillers
By GARDINER HARRIS and ALEX BERENSON
Published: December 24, 2004
WASHINGTON, Dec. 23 - The Food and Drug Administration recommended Thursday that doctors limit prescriptions for the popular pain pills Celebrex and Bextra because recent studies have suggested that they may increase the risk of heart attack and stroke.
The agency's advisory did not ban prescriptions of the drugs for any group of patients, instead simply telling doctors to use their best judgment in light of those studies. Indeed, it said patients who were at high risk of gastrointestinal bleeding or had done poorly on other pain pills "may be appropriate candidates" for Celebrex and Bextra.
Still, doctors may "decide to use other agents instead of these agents until we can sort out more clearly what the data show," said Dr. John Jenkins, director of the agency's Office of New Drugs.
The advisory also urged consumers to pay close attention to the directions for over-the-counter painkillers and to follow them carefully. But with regard to Celebrex and Bextra, it was less forceful than one issued Tuesday by the Medicines and Healthcare Products Regulatory Agency in Britain, which advised doctors to switch arthritic patients with heart disease to other medicines "as soon as is convenient." ...
http://www.nytimes.com/2004/12/24/politics/24fda.html