| Bextra Removed from Market
By Charles Seabrook
Cox News Service
04/08/05
At issue is a class of painkillers known as nonsteroidal antiflammatory drugs, which include prescription medications Vioxx and Celebrex, as well as over-the-counter drugs such as Motrin and Advil, which are ibuprofens, and Aleve and Naprosyn, which are naproxens.
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Millions of chronic pain sufferers, including aging baby boomers feeling their first twinges of arthritis, faced added agony yesterday when a popular painkiller was yanked off the market and drug firms were ordered to place tough warnings on others.
Catching doctors and consumers by surprise, the Food and Drug Administration asked pharmaceutical giant Pfizer to voluntarily withdraw its blockbuster painkiller Bextra from the market amid worries it increases the risk of a potentially fatal skin allergy -- on top of concerns about heart attack and stroke risks.
Few Choices Left
"It caught doctors and pharmacists completely off guard," said Lennie Duensing of the American Academy of Pain Management. "We're trying to get a grip on it."
Bextra accounted for 12.8 million prescriptions last year and US$1.3 billion in sales, according to industry experts.
The FDA action leaves chronic pain sufferers with few choices for relief between over-the-counter drugs like aspirin and Tylenol, or acetaminophen, and prescription narcotic painkillers. It also delivers another painful shot to the nation's multibillion-dollar painkiller drug industry.
At issue is a class of painkillers known as nonsteroidal antiflammatory drugs, which include prescription medications Vioxx and Celebrex, as well as over-the-counter drugs such as Motrin and Advil, which are ibuprofens, and Aleve and Naprosyn, which are naproxens.
Bextra, Celebrex and Vioxx, "selective NSAIDS" known as Cox-2 inhibitors, were hailed as wonder drugs by millions of patients when introduced in the 1990s. The drugs greatly reduce chronic pain without such side effects as gastrointestinal bleeding, a complication of earlier painkillers used for long-term relief.
Side Effects
But concerns that Vioxx put patients at risk for heart attack and stroke led to the drug's withdrawal last September.
While Celebrex was allowed to remain on the market, the FDA said yesterday it would have to display "black box" warnings -- the strongest possible -- detailing the increased risk of heart attack and stroke.
The FDA said it will require makers of 18 other prescription and nonprescription painkillers, including Motrin, Advil, Aleve and Naprosyn, to strengthen warnings about possible heart and stroke risks and potentially life-threatening gastrointestinal bleeding.
Two other common pain relievers, Tylenol and aspirin, were not affected, although the drugs are not problem-free. In high doses, aspirin can cause severe bleeding and Tylenol can cause liver problems.
"Aspirin is wonderful, but it's certainly the least safe in high doses," said Dr. Donna Gibbas, an Atlanta pediatric rheumatologist.
Clara Blackwell, 70, of Marietta, who has taken Bextra for more than three years for occasionally "very severe" pain, heard the news about the drug as she made a routine visit to her physician, Dr. W. Hayes Wilson, chief of rheumatology at Piedmont Hospital.
"[Bextra] has really helped me," she said Blackwell said she and her doctor had discussed the possibility the drug could be taken off the market, but he had "advised me to stay on it."
Black Box Warning
"I'm sure there is something out there to take its place, or will be, but my pain can be very severe, and I need something," she said. "You don't sleep. Sitting too long is painful. You have to stay active. So I'm very disappointed."
Wilson said he was upset that Bextra will no longer be available to help his patients with their pain.
"It is very perplexing," he said. "I think we're all worried now. I was just checking my e-mail, and one of my fellow rheumatologists asked, 'What are we going to do now?' We have run out of options. They are going to put this black box warning on Advil and Motrin, which is going to scare patients like a warning on a cigarette pack."
Wilson said he thinks "there are going to be hundreds of thousands of people who're going to be upset."
Gibbas, the pediatric rheumatologist, said the medications in question "are of huge value for our patients because there is such a danger with ulcers."
Gerry Sotomayor, an obstetrician at Northside Hospital, said Bextra was useful for his patients with chronic menstrual cramps and hemorrhaging. He said the decision to pull the drug "has caused problems for all of us."
Fatal Skin Condition
He said he has prescribed Bextra for short periods of time and never saw any problems from his patients.
"All my patients did well with Bextra," he said. "It was a drug they used sporadically. It wasn't a drug for constant use."
Now, Sotomayor said, he will recommend other drugs, like Motrin and Aleve.
"We have other alternatives," he said. "The universe hasn't ended with this."
The FDA said yesterday that Bextra was singled out because it can cause a potentially life-threatening skin condition called Stevens-Johnson syndrome, an allergic reaction that usually begins as a blistering of the mouth and lips and can spread to the rest of the body and become infected, resulting in fatal sepsis.
"There have been reports of serious and potentially life-threatening skin reactions and even deaths of people on Bextra," said Dr. Steven Galston, acting FDA director. "The reports on these skin reactions are more common for Bextra than Celebrex."
Celebrex Remains
Officials with Pfizer, the world's largest drugmaker, disagreed with the FDA's conclusion but said they would withdraw Bextra pending further discussions with the agency.
"For now, patients should stop taking Bextra," Pfizer said.
Celebrex, with sales of $3.3 billion last year, will be the nation's only Cox-2 inhibitor on the market.
FDA officials emphasized that the over-the-counter pills are safe if taken as directed, generally for no more than two weeks at a time.
While the agency insisted that it does not have enough research to say which drug is safest, some experts said the medicine found in Naprosyn and Aleve is probably the safest among that class of painkillers.
Doctors braced for a deluge of confused patients wondering which pain relievers are safe.
Dr. Doyt Conn, director of the rheumatology division at Emory University School of Medicine, said about 45 million Americans suffer chronic arthritis pain, but only 5 percent of them need Cox-2 inhibitor drugs to prevent gastrointestinal bleeding.
The problem, he said, is that the pharmaceutical companies that make Vioxx, Celebrex and Bextra have poured money into heavily promoting them. He said the companies spent about $3 billion on direct-to-the-consumer advertising in 2002, and another $10 billion on advertising to doctors.
Erring on Side of Caution
"This small cardiovascular problem becomes a large problem because of the large percentage of users," Conn said.
Dr. John Klippel of the Atlanta-based National Arthritis Foundation said the FDA is erring on the side of caution.
"But we don't want consumers to lose confidence in this drug class," he said.
Dr. Ines Berger, a rheumatologist at the Medical College of Georgia in Augusta, said the FDA's action may cause people to use the drugs more wisely and prudently.
"We should all use common sense when taking any drug," she said. "If we use these drugs prudently, they are safe."
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