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Painkiller Bextra pulled from market

WASHINGTON—Pfizer Inc. pulled its troubled painkiller Bextra from U.S. and European pharmacies Thursday after the Food and Drug Administration said the medication posed a risk of rare but life-threatening skin reactions.

Bextra's removal was the most aggressive of several changes that the agency called for Thursday to more tightly regulate a troubled family of popular pain relievers known as non-steroidal anti-inflammatory drugs (NSAIDs). While they relieve pain, there's growing concern at the FDA and among doctors and consumers over their side effects, which can include stomach bleeding, heart attacks, strokes and other potentially grave ailments.

Vioxx, which drug maker Merck & Co. withdrew last year amid reports of deadly cardiovascular side effects, is in the same class as Bextra: an NSAID known as a Cox-2 inhibitor. The troubled NSAID family also includes prescription painkillers such as Voltaren and Daypro, as well as over-the-counter pain relievers such as Motrin, Aleve, Advil and other forms of ibuprofen for which the FDA now wants tougher warning labels.

In a prepared statement, New York-based Pfizer said it disagreed with the FDA's finding on Bextra and promised to explore ways to get the drug back on the market. "For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options," the company urged.

Bextra's withdrawal leaves Pfizer's Celebrex as the only Cox-2 inhibitor on the market. The FDA, however, wants a tough new alert known as a "black box" warning added to Celebrex's labeling. It would warn consumers of the drug's link to heart attacks and strokes—the same problems that forced Merck to yank Vioxx off pharmacy shelves in September.

Similar cautions apply to the entire family of NSAIDs, prescription and non-prescription, said Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research. "All of these drugs should be used in the lowest effective dose that works for that patient for the shortest period of time."

In addition, the FDA on Thursday called for:

_ Black box warnings about potential heart problems and stomach bleeding on all prescription NSAIDs.

_ Medication guides for all prescription NSAIDs, given to patients by pharmacists to remind them of the drugs' hazardous side effects.

_ Product labeling for all NSAIDs sold without a prescription—except aspirin—that provide more information about side effects and additional advice to consumers.

_ Labeling for over-the-counter NSAIDs that includes, as prescription NSAIDs do, warnings about potential adverse skin reactions.

FDA officials said they asked drug companies to comply voluntarily to avoid lengthy legal wrangling. Drug companies seldom contest FDA actions on issues of public safety. Pfizer and other drug makers will work with FDA staff to draft the new warnings and precautions.

It's unclear when they'll be finished, but consumer advertising for all the targeted medications will reflect the new concerns immediately, Galson said.

FDA officials said their actions Thursday were consistent with the recommendations of an advisory panel that met in February to consider the future of the Cox-2 variants. The panel voted 31-1 to keep Celebrex on the market but was split on Vioxx (17-15) and Bextra (17-13 with two abstaining).

The panel concluded that Vioxx posed the greatest heart risks among the Cox-2s while Celebrex appeared to pose the least risk. The Cox-2s reported advantage over traditional painkillers has been that they're easier on the stomach.

Galson said life-threatening skin reactions were more common with Bextra than with Celebrex. In addition, "there isn't a demonstrated advantage (with Bextra) compared to the other (pain relievers). So no added advantage and a special risk is what led us to the change with Bextra," Galson said.

Pfizer suspended sales of Bextra in the European Union at the request of European regulators. The company said it's working with other regulatory agencies around the world and "will take appropriate measures based on those discussions."

Merck spokeswoman Jeanine Clemente refused to say whether Merck planned to try to bring Vioxx back onto the market with a new, tougher label, given the FDA's actions.

In a prepared statement, the company said: "It is important to recognize that the millions of patients who continue to suffer with pain need effective therapies, and selective COX-2 inhibitors have provided important therapeutic benefits to patients. We look forward to discussions with the FDA."

The FDA's moves brought mixed reviews from outside experts.

Dr. Bruce Psaty, a University of Washington pharmacology professor and frequent FDA critic, said the agency "has done a good job of trying to clarify things for people ... of taking the available information, using the recommendations of the advisory committees, and, in this instance, taking regulatory action that makes sense."

The agency's decision to remove Bextra but keep Celebrex on the market with stronger labeling requirements was "enormously rational," considering that many people need a painkiller that's easier on the stomach than traditional ones, said Dr. Brian Strom, chair of the Department of Biostatistics and Epidemiology at the University of Pennsylvania School of Medicine.

Consumer advocate Jeannine Kenney, senior policy analyst for Consumers Union, was less impressed.

"Consumers shouldn't have to wait until millions of Americans are put at risk before the FDA takes action," Kenney said. "The FDA badly needs reform of its reactive, passive drug safety system into one which proactively investigates safety concerns and takes action before Americans are harmed."

Pfizer stock, down most of the day, finished up 4 cents to close at $26.90. On Wednesday, the drug giant announced it was sharply scaling back earnings estimates and would seek cost cuts totaling $4 billion. The bad news followed the company's announcement that 2005 net earnings were projected to be $8.6 billion compared with $11.4 billion last year.

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For more information about Thursday's FDA actions, go to: http://www.fda.gov/bbs/topics/news/2005/NEW01171.html

For more on Cox-2 inhibitors and other NSAIDs, go to:

http://www.fda.gov/cder/drug/infopage/cox2/default.htm

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CONSEQUENCES OF THE FDA'S DECISIONS

Here are the consequences of the Food and Drug Administration's decisions Thursday on prescription and over-the-counter painkillers:

_ Aspirin and acetaminophen, such as Tylenol, are unaffected.

_ The prescription painkiller Bextra is off the market and its users are asked to consult their doctors about what to do next. Celebrex will carry a much tougher label warning of cardiovascular side effects. Vioxx, now off the market, may come back on. If so, it will carry the same tougher warning label.

_ Over-the-counter painkillers such as Motrin, Advil and other versions of ibuprofen can be used as directed but will carry tougher warnings about cardiovascular, gastrointestinal and other risks. The FDA says these drugs should be used only at prescribed doses and for short periods.

_ Prescription-strength medicines in the same class, known as non-steroidal anti-inflammatory drugs, should be taken only in the lowest possible dose and with the counsel of a physician. Included are Voltaren, Cataflam, Arthrotec, Dolobid, Lodine, Nalfon, Ansaid, Indocin, Indomethegan, Toradol, Ponstel, Mobic, Relafen, Daypro, Feldene, Disalcid, Clinoril and Tolectin. Also included are prescription-strength versions of Aleve, Naprosyn, Naproxyn, Naprelan, Anaprox, Oruvail, Orudis and Actron.

Many of these drugs are available in different versions or in combinations.

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(c) 2005, Knight Ridder/Tribune Information Services.

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