Joint Advisory Committee Votes Celebrex Trial Demonstrated Safety

The FDA’s Arthritis and Drug Safety Committee and the Risk Management Advisory Committee voted 15 to 5, with a single abstention, that Pfizer’s PRECISION trial, which compared Celebrex (celecoxib) to ibuprofen and naproxen, demonstrated comparable cardiovascular safety.

Among the “no” votes, members expressed concern that while the trial demonstrated noninferiority it would be an overreach to say it demonstrated safety. “If I were reviewing this study for a paper I would have a lot of comments,” said Neil J. Farber, a professor of clinical medicine and medical director at Internal Medicine Group La Jolla. “There needs to be some spiffing up of the statistics.”

On a second question, the committee voted in favor of adding a warning to the labeling for naproxen about the drug’s interaction with aspirin, with 12 voting for such a warning, two voting for a contraindication of use for naproxen when taken with aspirin, and seven voting for no warning at all.