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.

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