Warning for Celebrex

 

FDA Warned About Arthritis Drug

February 8, 2001
WASHINGTON (AP) - There's no proof the much-promoted arthritis drug Celebrex is gentler on the stomach than older, cheaper painkillers, say government's scientific advisers.

The ruling was a blow to manufacturer Pharmacia Corp., which had hoped the panel would recommend that the Food and Drug Administration quit making Celebrex bear a warning that users risk ulcers.

The same FDA advisory committee will evaluate on Thursday the ulcer potential of Celebrex's chief competitor, Merck & Co.'s arthritis drug Vioxx.

Celebrex, Vioxx and a class of older painkillers called NSAIDs -
"nonsteroidal anti-inflammatory drugs" that include ibuprofen and naproxen - all bear identical warnings that long-term users are at risk of developing ulcers, even life-threatening gastrointestinal bleeding.

Celebrex and Vioxx work slightly differently than older painkillers, and thus proponents hoped they would prove gentler on the stomach. Despite the FDA warning, the drugs have become blockbuster sellers based on that hope.
Together, they made some $5 billion in sales last year.

The FDA's advisers evaluated new research comparing Celebrex to older painkillers Wednesday and concluded it offers no meaningful safety advantage. The FDA isn't bound by its advisers' recommendations but normally follows them.

The ruling came as the FDA released a warning letter chastising Pharmacia for "repeated promotional activities" that minimize certain Celebrex risks, including the risk of gastrointestinal bleeding when heart patients take the arthritis drug together with the blood thinner Coumadin. In the last year, the FDA has repeatedly cited Pharmacia for false or misleading marketing.

Copyright 2001 The Associated Press. All rights reserved.

Back ] Up ]

DISCLAIMER:

The materials and information on this server are intended for educational and informational purposes only. The materials and information are not intended to replace the services of a trained health professional or to be a substitute for medical advice of physicians and/or other health care professionals. The International Still's Disease Foundation is not engaged in rendering medical or professional medical services. You should consult your physician on specific medical questions, particularly in matters requiring diagnosis or medical attention. The International Still's Disease Foundation makes no representations or warranties with respect to any treatment, action, application medication or preparation by any person following the information offered or provided within this website.  Any information used from other websites was done so with permission from each site, with an exception to those of "public domain", whereas we believe any site without a cited reference was a "public domain site" and for our use.  The International Still's Disease Foundation is a non-profit organization.   This page was last updated on January 17, 2001

Copyrightę 1999-2001 International Still's Disease Foundation