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 May 12, 2005
Pfizer Withdraws Bextra From Market
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By E.J. Mundell, HealthDay Reporter

THURSDAY, April 7 (HealthDay News) -- Although it disagreed with the government's recommendation, pharmaceutical giant Pfizer Inc. Thursday pulled the painkiller Bextra from American and European markets.

Pfizer's decision to discontinue marketing Bextra came as part of a series of new FDA actions that mandate black-box warnings on all similar prescription drugs and labeling changes for comparable over-the-counter medicines.

"We've asked Pfizer, and they've agreed, to stop selling Bextra," Dr. Stephen K. Galson, acting director of the FDA Center for Drug Evaluation and Research, told reporters at a teleconference Thursday.

He and other FDA officials cited heightened cardiovascular risks associated with long-term use of the drug, part of a family of medications called cox-2 inhibitors, as well as incidents of a rare but potentially fatal skin reaction, as the primary reasons for pulling Bextra from the market.

Galson also announced that "all manufacturers of prescription NSAID drugs -- including what remains the only cox-2-specific drug on the market, Celebrex -- to include a boxed warning, our highest-level warning, on the label."

He said the tough new labeling "highlights the major risk of these products, which are gastrointestinal bleeding and cardiovascular adverse events."

Besides Pfizer's Celebrex, which is being allowed to stay on pharmacy shelves pending further study, other popular, prescription non-steroidal anti-inflammatory drugs (NSAIDS) covered by the "black-box" labeling order include prescription dosages of naproxen and prescription dosages of ibuprofen.

Galson said all prescription NSAIDS will also come with special "Medication Guides" further outlining these risks, to be provided to consumers by pharmacists as they fill their prescriptions.

In addition, the FDA will require labeling changes for all over-the-counter NSAIDS, including popular brands such as Advil, Aleve, Motrin and generic ibuprofen. These changes, while not as strongly worded as the black box warning, will alert consumers to possible cardiovascular and gastrointestinal risks associated with long-term use.

Aspirin is exempt from any warnings, officials added.

Almost as soon as the FDA made the announcement, critics from both sides, including Pfizer and the consumer watchdog group Public Citizen, faulted the agency.

In a statement issued Thursday, Pfizer said it "respectfully disagrees with FDA's position on the overall risk/benefit profile of Bextra. However, in deference to the agency's views, the company has decided to suspend sales of the medicine pending further discussions with the FDA."

The company even suggested Bextra might, under certain circumstances, re-enter the marketplace.

When questioned on the possibility, Dr. John Jenkins, director of the FDA's Office of New Drugs, told reporters that "the basis for our decision on Bextra was related to the fact that it had no unique benefit and that it had the unique risk for the skin reaction. So, the path forward -- if there is to be a path forward -- would have to address part of that equation, to bring the balance back into a favorable position [for the drug]."

Any additional data that might improve Bextra's cardiovascular standing vis-a-vis other NSAIDs might also lead the FDA to reconsider the ban, he said.

But Public Citizen, a nonprofit consumer advocacy group and frequent FDA critic, said the agency actions didn't go far enough.

In a strongly worded statement, the group's director, Dr. Sidney Wolfe, applauded Bextra's demise but added that the agency has also "recklessly allowed Celebrex to continue to be sold," despite its known cardiovascular risks.

"We call on Congress, which is finally delving into FDA's operations, to investigate why the agency is not pulling the equally dangerous Celebrex from the shelves," the statement said.

The FDA has come under fire recently, especially in a recent article in The New York Times that suggested that some members of the special Arthritis and Drug Safety and Risk Management Advisory Committee, convened this winter to review cox-2 inhibitors, had financial ties to the drug industry that might have influenced their decisions.

Responding to the charge, the FDA issued a statement Thursday in which it said that, after a review, "conflicts of interests were found. However, these conflicts were not deemed to be of sufficient magnitude to outweigh the need for the members' and consultants' expertise for this meeting." And the statement added, "we do not believe that any of the conflicts of interest affected members' recommendations."

Those recommendations, issued in mid-February, advised that all three cox-2 inhibitor medications -- Vioxx, Celebrex and Bextra -- be allowed to stay on the market, albeit with strongly worded labeling.

Thursday's action appears, in part, to overrule the committee's recommendations, but Galson told reporters that the ban on Bextra doesn't stray far from the panel's findings.

"The panel votes were fairly closely split on Bextra, in particular, so we think our decisions are consistent," he said. "I don't think we overrode the panel's recommendation."

Galson defended the agency's flagging reputation, stressing that any decisions about the safety and marketability of drugs must and should change as new data emerges.

"There's no such thing as advisories and approvals that are cast in cement with no hope of change, and that's what's happened over the last while -- we've gotten new information and so now that advice [to consumers] and regulatory status changes," he explained.

Despite Pfizer's hopes for a reversal on Bextra, Thursday's announcement could be the death knell for the drug, which FDA experts say has been linked to increased cardiovascular and gastrointestinal risks, as well as isolated and unpredictable incidents of a serious, life-threatening skin disease, Stephen Johnson syndrome.

Agency officials also said Bextra appears to offer patients no added therapeutic benefit that can't be found in other available medications.

As for blockbuster Celebrex, also made by Pfizer, agency officials concluded that the drug's benefits still outweigh any risks to patients. But the drug will carry the heightened black-box warning, and the special "Medication Guide" now mandated for all prescription NSAIDS.

The FDA is also asking that Pfizer "commit to conduct a long-term study of the safety of Celebrex compared to naproxen [Aleve] and other appropriate drugs."

A third cox-2 inhibitor, Merck Inc.'s Vioxx, was voluntarily withdrawn from the market in September of last year, after a major study linked long-term use with cardiovascular disease.

According to Galson, "If we do get a proposal from Merck to bring Vioxx back to market, we'll consider it carefully." If the FDA feels it warrants serious consideration, the proposal would then go through the standard Advisory Committee review process, he said.

Thursday's ruling leaves millions of Bextra users wondering what to do next.

First of all, Galson said, "All of these drugs should be used in the lowest effective dose -- the lowest dose that works for that patient -- for the shortest period of time. That's really the important advice that underlies the use of all of these products, both OTC and prescription."

Ultimately, he said, each patient is an individual, and must make treatment decisions based on a talk with his or her doctor.

More information

For more on Thursday's actions involving these painkillers, visit the FDA (www.fda.gov ).

SOURCES: News conference with Stephen K. Galson, acting director, U.S. Food and Drug Administration's Center for Drug Evaluation and Research; John Jenkins, M.D., director, FDA's Office of New Drugs; Pfizer Inc. statement; Public Citizen statement

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