FDA Consumer: Labeling Changes For Arthritis Drug

Although the new COX-2 drugs offer great promise, the definitive answer on whether they cause fewer gastrointestinal complications is not in yet. The data that Searle's researchers submitted to the U.S. Food and Drug Administration came primarily from endoscope tests, in which patients' stomachs were examined visually for signs of ulcers after three months on the drug.

The researchers found that between 7% and 7.5% of Celebrex users had visible ulcers, compared with 9.7% on Diclofenac, 23.3% on ibuprofen and 34.6% on Naproxen.

While the results are promising, the FDA said that to prove Celebrex's relative safety, Searle would have to do more studies. In the meantime, Celebrex's label must carry a warning about bleeding, ulcerations and perforation of the stomach or intestines, just as traditional NSAID labels do.

If one have been taking anti-inflammatories for arthritis without problems, bear in mind that the longer one take them, the greater one’s risk of developing gastrointestinal complications, most of which occur without warning. Each year, 103,000 people are hospitalized and 16,500 die because of ulcers, internal bleeding and other NSAID side effects. Even those who use NSAIDs short-term--say, after dental surgery--may experience serious side effects.

Among the people most at risk are those who are 65 or older, have ever had an ulcer or gastrointestinal bleeding or take blood thinners or prednisone, a steroid, along with NSAIDs. Any of these risk factors could make you a Celebrex candidate.