NYT: F.D.A. Urges Doctors to Limit Prescriptions for Celebrex and Bextra

[DeepModem Mom]

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

[robbedvoter]

1. Oh, well, back to aspirin for the educated consumer

(if they ever left)

[teryang]

2. The dynamics of this similar to the Fen-phen debacle

Politics at the FDA delaying appropriate action. The Europeans are way ahead on this, as usual. By issuing the advisory, Doctor's should be aware that the FDA is shifting legal liability from the producers to the doctor as the "learned intermediary."

As the individual doctor is easier to sue than a behemoth corporation like Pfizer, a renewed political campaign attacking "trial lawyers" and promoting so called "tort reform" will be next. Those doctors that assume that the drug industry and their interests are in harmony should guess again.

[LeighAnn]

3. What about those commercials?

the ones where everybody's celebrating and being happy, and they have the Three Dog Night song, "Celebrate" playing in the background? I never was sure what Celebrex was for, but hoped I'd get whatever condition it was, because the commercials made being on Celebrex seem like it would be a really good time.