After a two-year hiatus, Pfizer is again advertising its pain reliever celecoxib (Celebrex) with a direct-to-consumer TV ad. The company had voluntarily suspended such advertising of Celebrex in December 2004 after evidence suggested that the drug, like its previously withdrawn cousin rofecoxib (Vioxx), might increase heart attack or stroke risk.

The ad suggests that the medication is no riskier for the heart than other prescription nonsteroidal anti-inflammatory drugs (NSAIDs), such as naproxen (Naprosyn and generic), and is possibly easier on the gut. We think that the claims, which also appear at www.celebrex.com, don’t tell the whole story.

For our analysis, we asked Gail Cawkwell, M.D., Ph.D., Pfizer’s senior medical director for Celebrex, to provide supporting evidence for the claim. Then we commissioned experts on communicating medical information to review that and other evidence on the medication. We also combed the medical literature and asked drug-safety experts, specialists in heart and joint diseases, and the Food and Drug Administration to weigh in. Here’s what we found:

The claim. All prescription NSAIDs--not just celecoxib--may increase the chance of heart attack or stroke.

CR’s take. Since April 2005 all prescription NSAIDs have carried the same FDA-approved black-box warning, the most serious label alert, about increased cardiovascular risk. But that’s largely because the FDA didn’t have enough data to rank the drugs for safety. There’s more evidence now that at least one prescription pain reliever, naproxen, might pose less heart risk than celecoxib.

Although the evidence is mixed, some meta-analyses, which assess the combined data from many clinical trials, have linked celecoxib at moderate to high doses to an increased likelihood of heart attack compared with either a placebo or naproxen. Similarly, some analyses and other studies suggest that naproxen might not threaten the heart. A September 2006 report from the federal government’s own Agency for Healthcare Research and Quality supported those conclusions.

Five months later the American Heart Association went further, recommending that celecoxib be the NSAID of last resort for people with increased coronary risk. The association based its advice mainly on the ways that celecoxib acts in the body, which in theory may harm the heart more than the effects of other NSAIDs.

The claim. All NSAIDs increase the chance of bleeding and other potentially fatal gastrointestinal effects, which can occur without warning. But in clinical studies, a lower percentage of patients on celecoxib reported indigestion, abdominal pain, and nausea vs. those on ibuprofen and naproxen.

CR’s take. Celecoxib might be tolerated a bit better than other NSAIDs. But that doesn’t mean it’s safer for the stomach and bowels. Gastrointestinal bleeding, obstruction, and perforation, not abdominal pain and nausea, are the “clinically important outcomes” for judging such safety, says Sharon Hertz, M.D., the FDA’s deputy director for the division of anesthesia, analgesia, and rheumatology products. Experts we consulted said there’s no conclusive evidence that celecoxib is less likely than other NSAIDs to cause those serious side effects.

The bottom line. Until there’s firmer evidence, naproxen appears to be a better choice than celecoxib for most people who have increased coronary risk and need a prescription NSAID. Even if you’re in good health, don’t let the TV ad send you clamoring for celecoxib. There’s no evidence that Celebrex relieves pain better than other NSAIDs. It may pose greater heart risk than at least one widely used prescription NSAID, and it costs more than most of the others. For more information on choosing the best treatment, talk with your doctor or go to our CR Best Buy Drugs report on NSAIDs and free updates and safety alerts.