Celebrex Label Must Include Warning About Potential Ulcer Complications, FDA Says
After reviewing the results of a recent study, the FDA on Saturday said that drug manufacturers Pharmacia Corp. and Pfizer Inc. must continue to carry a warning label on their arthritis treatment Celebrex stating that the drug can cause serious ulcer complications similar to many other pain relievers, the New York Times reports (Petersen, New York Times, 6/9). The label states, "Differences in the incidence of complicated ulcers between Celebrex and the combined group of ibuprofen and diclofenac were not statistically significant" (Harris, Wall Street Journal, 6/10). The decision was made based on the results of a study of 8,000 people with arthritis in which 4,000 were given Celebrex and 4,000 were given ibuprofen or diclofenac, two common anti-inflammatory drugs. According to Lawrence Goldkind, deputy director of the FDA's division of anti-inflammatory, analgesic and ophthalmic drugs, the study "did not prove that Celebrex was better for the stomach." However, Goldkind added that a "failure to show a difference is not the same as showing that things are the same." He said that the study had "complicating issues," including the fact that some patients took aspirin, which is known to cause stomach ulcers (Okie/Kaufman, Washington Post, 6/8). The FDA also announced yesterday that the risk of heart attacks among Celebrex patients was "no higher" than for patients taking generic pain relievers.
The announcements meant mixed prospects for future sales of Celebrex, which is engaged in a "heated marketing battle" with Vioxx, a drug manufactured by Merck & Co. (New York Times, 6/9). Last April, after examining the results of a comparative study, the FDA said it would allow Merck to claim that Vioxx has a "lower risk of causing ulcers, gastrointestinal bleeding and related digestive-tract complications" than older pain relievers (Washington Post, 6/8). But the FDA also said that Vioxx showed a "higher risk of cardiovascular events" in comparison to the painkiller naproxen (Krauskopf, Bergen Record, 6/8). Neither Celebrex nor Vioxx has been shown to reduce pain any better than generic anti-inflammatory drugs, so the drugs' manufacturers have been working to convince physicians and health plans that the two drugs have a lower risk of causing ulcers (New York Times, 6/9). Last week, a study released by pharmacy benefits manager Express Scripts Inc. found that Cox-2 inhibitors such as Celebrex and Vioxx are "over-prescribed, overpriced and an unnecessary expense for health plans" (California Healthline, 6/4). Sharon Levine, executive vice president of Kaiser Permanente, said, "With the FDA action, there appears to be no good reason to prescribe Celebrex given that it's many times more expensive than ibuprofen" (Wall Street Journal, 6/10).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.