FDA Advisory Panel Upholds Ulcer Warning Label for Celebrex
There is no proof that Pharmacia Corp.'s arthritis medication Celebrex is "gentler on the stomach" than older, less expensive painkillers, and the drug should retain its label warning users they may develop stomach ulcers, a panel of scientific advisers to the FDA concluded yesterday, the AP/Nando Times reports. Evaluating "new research" comparing Celebrex to older painkillers such as ibuprofen, the advisers found the medication offered "no meaningful safety advantage" -- a "blow" to Pharmacia, which had hoped the panel would suggest the FDA discontinue the mandatory warning label on Celebrex. The FDA is not obligated to follow advisers' rulings but normally chooses to do so. The ruling came on the heels of an FDA "warning letter" admonishing Pharmacia for using promotional activities that downplayed risks associated with Celebrex use, including gastrointestinal bleeding when taken with the blood thinner Coumadin. The same panel today will evaluate the ulcer potential of Merck & Co.'s rival arthritis medication, Vioxx (AP/Nando Times, 2/7).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.