At issue: whether anti-inflammatory medicines called NSAIDs — the backbone of U.S. pain treatment — raise the risk heart attacks and strokes, particularly when taken at high doses or for long periods of time.
Pfizer Inc. reluctantly pulled its blockbuster painkiller Bextra off the market Thursday at the Food and Drug Administration's behest. As CBS News Correspondent Sharyl Attkisson reports, Bextra is the third drug of it's kind — the so-called COX-2 drugs — to be pulled from the market after the FDA once vouched for its safety.
Attkisson reports that in addition to heart and stomach risks, the FDA said Bextra had far more serious skin problems than the last drug in the group left on the market, Celebrex.
And the FDA ordered its toughest possible warning about cardiovascular risks on 19 other prescription competitors, from Celebrex to Mobic to high-dose naproxen.
The warnings don't say which drug is the safer choice. The FDA insists there's not enough research yet to rank them, although many drug specialists caution that there are indeed differences — and that some older standbys, like naproxen, shouldn't be causing new concern.
Also, the FDA will strengthen existing warnings on over-the-counter NSAIDs — ibuprofen, naproxen and ketoprofen that consumers have long popped like candy — that the pills are for short-term use at low doses, to avoid their prescription competitors' risks.
"The FDA is erring on the side of caution by putting a warning for all NSAIDs," said Dr. John Klippel of the Arthritis Foundation, where anxious patients already were calling Thursday seeking advice. "But we don't want consumers to lose confidence in this drug class."
The saga began last September when Merck & Co. voluntarily pulled its pain reliever Vioxx off the market after a study showed long-term use doubled patients' risk of heart attacks and strokes. Pfizer Inc.'s Bextra and Celebrex are similar drugs, a subset of NSAIDs known as cox-2 inhibitors, and studies show they also can raise cardiovascular risks, although apparently to a smaller degree than Vioxx.
Thursday, the FDA said Bextra should quit selling because, in addition to the cardiac concern, it appears to cause rare but serious skin conditions — some fatal — more often than do other NSAIDs. Sales were stopped in the European Union, too.
Pfizer's Celebrex still can sell, the FDA announced Thursday.
But it and all other prescription NSAIDs must carry a major warning on the label that long-term use may cause serious cardiovascular side effects or gastrointestinal bleeding. No one who recently underwent heart bypass surgery should use prescription-strength NSAIDs, the warning stresses.
Also, patients are to receive a special pamphlet with every NSAID prescription filled that spells out the warnings in consumer-friendly language.
Thursday's move was a blow to Pfizer, which said it "respectfully disagrees" with FDA's conclusion about Bextra, which had sales of $1.3 billion last year, is too risky. Pfizer pledged additional research on Bextra's heart risks and said it would try to bring back the drug.
Use of cox-2 inhibitors skyrocketed, particularly by people with arthritis and other chronic pain, when they hit the market in the late 1990s because of claims that they were easier on patients' stomachs than traditional painkillers. The FDA cautioned that those claims were never proven.
Celebrex, with sales of $3.3 billion last year, remains the nation's last cox-2 inhibitor.
It should be prescribed only for patients not helped by other painkillers, or who are at particularly high risk for stomach problems, said Vanderbilt University pharmacologist Dr. Alastair Wood, who advises the FDA on drug safety.
For chronic pain, such as arthritis, Wood recommends starting patients on naproxen, along with a stomach-protecting drug if necessary.
There are studies that show naproxen poses far fewer heart risks than Celebrex or the other now-defunct cox-2 inhibitors, said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen. He called the FDA's decision to put the same warning on every NSAID "incredibly reckless."
These painkillers are "still very good drugs," stressed Dr. Thalia Segal of the New York University Pain Center. But, "we're not supposed to take them for life anymore."
Instead, she advises looking for non-pill therapies where possible. Lidocaine pain patches, for example, help knee arthritis, as does losing weight, she said.
But stay tuned: The FDA asked painkiller makers to sift through their research and help figure out which pills are safest.
"Let me emphasize now, this announcement is unlikely to be the last word you'll hear on these drugs," said FDA drug chief Dr. Steven Galson.