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FDA Puts Bextra on Do-Not-Sell Drug List

Posted on: Friday, 8 April 2005, 21:00 CDT

Apr. 8--Pfizer Inc. pulled the pain pill Bextra from the market Thursday at the request of the Food and Drug Administration, which also called for stronger warnings of heart risks for a broad swath of pain treatments.

In the latest fallout involving a controversial class of painkillers, the agency cited a greater risk of potentially deadly skin reactions with Bextra in its decision, on top of the higher heart risks similar to other painkillers. Pfizer agreed to suspend sales of the drug, but said it "respectfully disagrees" with the FDA's position.

The action left Pfizer's similar pill, Celebrex, as the only drug of its kind available to doctors and their patients. And Celebrex will now carry a boxed warning highlighting the potential increased risk of cardiovascular side effects. Such "black-box" warnings are the FDA's strongest type of caution.

The agency also asked manufacturers to change the labels of other commonly used prescription anti-inflammatory drugs, such as ibuprofen and naproxen, to contain a similar warning of heart risks.

Further, the FDA requested manufacturers of over-the-counter drugs -- including Advil, Aleve and Motrin -- to add more specific information to their labels about potential cardiovascular and gastrointestinal risks. However, the agency said the available data do not suggest higher danger of heart problems with the over-the-counter drugs if they are used for the short time period and low dosages specified in the labeling.

The FDA has been investigating the painkillers since Merck & Co. pulled its widely used Vioxx pill off the market last fall. The Vioxx withdrawal -- which stemmed from a study showing increased risk of heart attacks and strokes -- was followed by findings questioning risks of other painkillers, and set off confusion among doctors and patients.

A federal advisory panel that convened in February to evaluate the painkillers voted that Celebrex, Bextra and even Vioxx should be allowed to be sold, although the margins supporting Bextra and Vioxx were thin.

But after a broad review, the FDA decided that Bextra should be removed because it had an "unfavorable" risk-benefit profile.

The agency cited reports of severe, life-threatening skin reactions with Bextra, and said the risk of encountering these reactions was "unpredictable," occurring after short or extended use.

Further, the agency said, a lack of long-term data exists for addressing the drug's heart risks.

At the same time, the agency said, Bextra holds no advantages over other anti-inflammatory painkillers.

"No added advantage and a special risk is what led us to the change with Bextra," Dr. Stephen Galson, acting director of the FDA's Center for Drug Evaluation and Research, said in a conference call with reporters.

More than 7 million people have taken Bextra since its approval in November 2001.

Bextra and Celebrex prescriptions spiked after the Vioxx withdrawal, but retreated after other studies began to raise questions about their heart safety as well.

Pfizer said the FDA told the company about its view on Bextra late Wednesday.

"In deference to the agency's views, the company has agreed to suspend sales of the medicine pending further discussions with the FDA," Pfizer said in a statement Thursday. Pfizer reported $1.3 billion in Bextra sales last year.

The company said it would explore options with the agency to bring back the drug. However, it advised patients to stop taking Bextra and talk to their doctors.

Pfizer also suspended Bextra sales in Europe at the request of regulators there, and said it was in talks with other regulatory agencies around the world.

Bextra, Celebrex and Vioxx belong to a class of drugs known as "cox-2 inhibitors." Cox-2 drugs are a subset of the broader class of non-steroidal anti-inflammatory medicines. Approved in the late 1990s, Celebrex and Vioxx raced to blockbuster status, fueled by giant consumer advertising campaigns.

While traditional anti-inflammatory drugs block two enzymes, including one that protects the stomach lining, cox-2 drugs are designed to avoid that enzyme. Thus, the pills carried the promise of being easier on the stomach -- a major issue for pain sufferers who take pills chronically and become sensitive to stomach bleeding and ulcers.

Questions about heart risks dogged cox-2 drugs almost as soon as they were launched, however. On Thursday, regulators said a wider group of anti-inflammatory medicines will carry increased cardiac-risk warning.

"The conclusion we've come up with is the cardiovascular risk of these drugs is considered a class effect," Galson said. The agency asked Pfizer to commit to a long-term safety study comparing Celebrex with naproxen and other drugs.

Critics seized on the Bextra withdrawal Thursday as evidence of the need for reform at the FDA.

"Removal of a dangerous drug from the market is a good thing, but it leads to the larger question -- why were these unsafe drugs being sold in the first place?" said Jeannine Kenney, senior policy analyst for Consumers Union.

Sen. Charles Grassley, R-Iowa, who heads the committee that held hearings last year on the Vioxx withdrawal, said in a statement Thursday, "What's happened with these painkillers has been a confusing saga for the people who need pain relief, and that can be attributed to systemic failures by the FDA and misplaced priorities of the drug industry."

Without Bextra, physicians may fall back on older, riskier pain relievers, Dr. David Arbit of The Valley Hospital in Ridgewood said.

Now, aside from Celebrex, "we're forced to use the older anti-inflammatory [drugs] that carry an increased risk of bleeding from the stomach, both prescription and over the counter," said Arbit, director of rheumatology at Valley.

Arbit prescribed Bextra for "hundreds of patients," but had no reports of problems.

He said he will continue to prescribe Celebrex for patients with arthritis pain.

Patients will be more reluctant to take Celebrex -- and regulators may scrutinize the drug more closely -- because of the fallout from Bextra, said Dr. Todd P. Stitik of the University of Medicine and Dentistry of New Jersey.

"Purely from the doctor's point of view, the loss of Bextra is not that big a deal," said Stitik, a physiatrist at UMDNJ-New Jersey Medical School in Newark. "But from patients' point of view, they might say, 'Whoa! Why should I even bother with this [Celebrex]?'

"I think they're going to be more nervous and leery" of taking Celebrex, he said.

In general, he will switch patients using Bextra to Celebrex if appropriate. Otherwise, "we'll move on to more traditional anti-inflammatories," he said.

READ THE LABEL: In addition to the request concerning Bextra, the FDA asked manufacturers of other prescription and over-the-counter painkillers containing ibuprofen, naproxen and other chemicals to revise their labels to clarify information about the risks of cardiovascular incidents, gastrointestinal bleeding and rare but serious skin reactions. Included in the list of brand-name products: Motrin, Advil, Aleve, Maprosyn, Naprosyn, Voltaren, Mobic.

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PFE, MRK,

Source: The Record - Hackensack, New Jersey

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