| Painkiller Bextra pulled from shelves
BY TONY PUGH
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 nonsteroidal anti-inflammatory drugs, or NSAIDs. While the drugs relieve pain, there is growing concern at the FDA and among doctors and consumers about 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.
The FDA is also calling for stronger warning labels for over-the-counter pain relievers such as Motrin, Aleve and other forms of ibuprofen.
In a 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 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 nonprescription, 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 to be given to patients by pharmacists to remind them of the drugs' hazardous side effects. The drugs include 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.
• Product labeling for all NSAIDs sold without a prescription -- Motrin, Advil, and other forms of ibuprofen -- that provide more information about side effects and additional advice to consumers.
• Labeling for over-the-counter NSAIDs -- like Motrin, Advil and other forms of ibuprofen -- that includes 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 is unclear when the work will 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 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 is 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.
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