Pfizer said today that it would immediately stop advertising Celebrex to consumers after a study showed that high doses of the drug, the companys best-selling arthritis pain reliever, were associated with an increased risk of heart attack.
The suspension of advertising, which is indefinite, includes television, radio, newspaper and magazine ads and other promotions to consumers, a Pfizer spokeswoman, Mariann Caprino, said. Some magazine ads may appear for a few more weeks because of the long lead time of magazine advertising, she added.
Pfizer appears to have had little choice in deciding to end the advertising campaigns. The Food and Drug Administration said on Friday that it was considering regulatory measures that could include severe label warnings or even requiring that the drug be withdrawn in the United States.
The federal agency agreed with the advertising withdrawal, Ms. Caprino said, adding, We discussed it with the F.D.A. and we all concurred that it was the appropriate step.
Pfizer spent $71 million advertising Celebrex to American consumers in the first nine months of this year, one of the biggest ad budgets for a prescription medicine. Those advertisements have annoyed some consumer advocates and scientists, who argue that they encouraged overuse of Celebrex among patients for whom the medicine offers little benefit over older drugs.
Analysts say that Pfizer is among the most aggressive marketers of drugs to both doctors and consumers. Last month, the F.D.A. forced the company to withdraw two television advertisements for Viagra, its medicine for erectile dysfunction, saying the ads overstated Viagras effectiveness.
Although consumer advertising will be suspended, Pfizer plans to continue marketing Celebrex to doctors, Ms. Caprino said. The company has thousands of sales representatives who visit doctors offices to encourage use of its medicines.
The suspension of consumer marketing may cause the sales of Celebrex and Bextra, a related drug of the group of COX-2 inhibitors, to drop. Sales of the drugs had been expected to total more than $4 billion worldwide this year, almost 10 percent of Pfizers revenue. Even before todays statement on advertising, analysts had predicted that sales of the drugs would fall in 2005 because of the questions about their safety.
Still, Pfizer has no plans to stop selling Celebrex, Pfizers chief executive, Henry A. McKinnell Jr., said in an interview on This Week, on ABC Television. For many patients, Celebrex works better than other pain medications, Mr. McKinnell said. The company will work to inform doctors of Celebrexs potential risks, he said.
Were leaving Celebrex on the market because it is an appropriate option for many, many patients, he asserted.
But George Sard, chairman of Citigate Sard Verbinnen, a crisis communications firm, said Pfizer was making a mistake in trying to keep Celebrex on the market.
Pfizer will inevitably have to recall Celebrex, Mr. Sard said, and I believe they are making a strategic error not doing it immediately. Their current position is untenable and the price of waiting will be increased legal, financial and reputational costs.
Some scientists have called on Pfizer to withdraw Celebrex from the market. And the F.D.A.s acting commissioner, Dr. Lester Crawford, said on Friday that doctors should consider moving patients on Celebrex to other drugs.
Pfizer maintains that Celebrex has not been shown to be dangerous when taken at the usual dose for arthritis patients. The heart risk in the study disclosed on Friday occurred only when patients took Celebrex at two to four times the usual dose for long periods. In addition, Celebrex had not been linked to heart attacks before Friday, although other studies had shown comparable problems with Bextra, as well as Vioxx, another similar drug made by Merck.
Celebrex and Bextra are two of Pfizers biggest selling medicines, accounting for about $4 billion in sales worldwide this year. Even before Friday, some scientists had called on the company to withdraw Celebrex and Bextra, asserting that the medicines offered no benefits over older painkillers like ibuprofen, the generic name for Advil and Motrin. Celebrex and Bextra have also been sharply criticized for their high costs compared with the older medicines. In the United States, they cost more than $2 a dose, compared with pennies for ibuprofen.
Celebrex, Bextra and Vioxx are a relatively new type of pain and arthritis medications called COX-2 inhibitors. Studies have now linked all three drugs to increased risks of heart attacks, and some scientists say that all COX-2 inhibitors appear to be inherently dangerous.
Merck pulled Vioxx from the market in September, after a study that showed the risk of heart attacks and strokes tripled for patients taking Vioxx for long periods of time.
But Pfizer asserts that the problems with Vioxx do not prove that Bextra and Celebrex are dangerous, though the drugs have similar chemical structures.
In the study that led Merck to withdraw Vioxx, patients showed an increased risk of heart attacks and strokes when they took 25 milligrams of Vioxx daily, the usual dose for arthritis patients. The Celebrex data made public on Friday showed an increased risk of heart attack in patients taking either 400 milligrams or 800 milligrams of Celebrex daily; most arthritis patients take 200 milligrams of Celebrex.