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Can Pfizer Prevent Celebrex Ban?

By Mark Huffman
ConsumerAffairs.com

December 20, 2004
Pressure is building on pharmaceutical maker Pfizer, Inc. to withdraw its pain-relieving drug, Celebrex, from the market in the wake of a study indicating it too may pose a risk of heart attack and strokes. The pain reliever Vioxx, made by Merck, was withdrawn in September because of similar health risks. Both drugs are so-called Cox-2 inhibitors.

Celebrex • Celebrex May Disrupt Heart Rhythm • Celebrex Gets Black Box Label • FDA Blasts Ads For Celebrex, Bextra • Can Pfizer Prevent Celebrex Ban? • Pfizer Finds Health Risk With Celebrex • Study Finds Celebrex Safer Than Vioxx • Celebrex Implicated in 14 Canadian Deaths --- Other NSAIDs • Merck Withdraws Vioxx • Pfizer Warns of Bextra Risks • Aleve Ingredient Seen as Health Risk •: Dangers of Cox-2 Drugs • Life Without Vioxx

Pfizer announced last week that clinical trials conducted by the National Cancer Institute had shown an increased risk of heart attack and strokes for those taking Celebrex. The trials were suspended, and the drug maker said it would push for further study.

While some consumer groups began calling for a Celebrex ban, company officials went on the defensive. In press interviews, the company's CEO, Dr. Henry McKinnell Jr., stood firm on the position Pfizer took last week, when it disclosed the new data.

But you won't see any ads for Celebrex for a while. Pfizer has suspended its marketing campaign for Celebrex, withdrawing all radio, newspaper and magazine advertising. According to Medical News Today, Pfizer has spent $71 million so far this year advertising the drug.

Pfizer not only faces the prospect of losing the revenue from its profitable drug, it could share the expensive fate of Merck, which now faces mounting lawsuits in connection with Vioxx. So far, the Food and Drug Administration has not taken a position on a mandatory recall.

"Although these are important findings, at this point FDA has seen only the preliminary results of the studies. FDA will obtain all available data on these and other ongoing Celebrex trials as soon as possible and will determine the appropriate regulatory action," the agency said in a statement.

"While we have not seen all available data on Celebrex, these findings are similar to recent results from a study of Vioxx (rofecoxib), another drug in the same class as Celebrex. Vioxx was recently voluntarily withdrawn by Merck. Another drug in this class, Bextra (valdecoxib) has shown an increased risk for CV events in patients after heart surgery. Bextra and Celebrex are the only two selective COX-2 agents currently on the U.S. market," the statement added.

The FDA said physicians should consider "this evolving information" in evaluating the risks and benefits of Celebrex in individual patients. The agency says patients who are currently taking Celebrex and have questions or concerns about the drug should discuss them with their physicians.

Celebrex was approved in 1998 for the treatment of osteoarthritis and rheumatoid arthritis. Along with Vioxx and Bextra, also Cox-2 inhibitors, it has come to be widely used by those with chronic pain, largely because it avoids the risk of gastric irritation that accompanies older, cheaper pain relievers like aspirin and ibuprofen.

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