| Painkiller Bextra taken off market
Fri, Apr 8, 2005
WASHINGTON (AP) — The painkiller Bextra was taken off the market Thursday, and the government wants similar prescription drugs to carry the strongest possible warnings about increased risk of heart attack and stroke among the millions of people who rely on them.
Pfizer Inc. suspended sales of Bextra in the United States and the European Union at the request of the Food and Drug Administration and European regulators. The company said that the FDA, in seeking Bextra's withdrawal, cited a risk of serious, sometimes fatal, skin reactions to Bextra on top of the risks shared by other similar drugs.
At issue are a broad class of painkillers known as nonsteroidal anti-inflammatory drugs, or NSAIDS. Bextra is a particular type of NSAID known as a Cox-2 inhibitor, a class of blockbuster sellers particularly popular among arthritis sufferers until a competitor — Vioxx from Merck & Co. — was pulled off the market last fall. That sparked questions about the safety of all similar drugs.
Pfizer's Celebrex can still sell, the FDA announced Thursday. But it, and all other prescription NSAIDS, must carry a black-box warning on its label that users may face an increased risk of cardiovascular side effects.
Scientists don't have enough information yet to tell if one of the remaining prescription painkillers is safer than another, FDA officials stressed. But, the agency decided that Bextra was more dangerous than its competitors because of the added skin side effect.
Pfizer shares dropped 40 cents, or 1.5 percent, to $26.56 in midday trading on the New York Stock Exchange. They have traded in a range of $21.99 and $37.90 over the past 52 weeks.
Over-the-counter pills
In addition to the prescription drugs, the FDA asked manufacturers of over-the-counter NSAID painkillers to revise their labels to clarify information about the risks of cardiovascular incidents, gastrointestinal bleeding and rare but serious skin reactions.
That doesn't mean the nonprescription drugs are dangerous, FDA officials stressed — but the strengthened wording will make clear that patients should take those drugs only at the labeled dosage for short periods of time.
"People should not have a concern about continuing to take those products per those directions," said Dr. Steven Galson, acting director of FDA's Center for Drug Evaluation and Research.
For users of prescription-strength NSAIDS, the government said there was no reason to panic but that people should consult their physicians about which painkiller is best suited for them — and to take the lowest effective dose.
"All these risks we're talking about have already been known," Dr. Galson stressed. "People should not worry about, from today to tomorrow, stopping the products."
Pfizer's advice to Bextra users: "For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options."
New York-based Pfizer said it "respectfully disagrees" with FDA that Bextra was too risky to continue selling and pledged further discussions with the agency about the possibility of returning it to the market.
Previous advisory
In February, advisers to the FDA had recommended that people who depend on Celebrex, Bextra and Vioxx be allowed to continue to use them despite the health risks — although it only narrowly backed Bextra. The panel said Vioxx posed the greatest heart risk and that Celebrex seemed have the fewest cardiovascular side effects among the Cox-2 drugs. It also recommended that the prescription drugs carry strong warnings, and that more study be done to better understand the drugs' risks.
In a statement, Merck said Thursday that while it respects the FDA's latest decision, "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."
Janet Skidmore, a spokeswoman for the Whitehouse Station, N.J.-based company, said the company had no immediate comment on whether the Bextra decision would influence any consideration to bring Vioxx back, or whether it will continue to seek approval for Arcoxia, a planned successor to Vioxx.
Merck shares fell 21 cents to $32.68 in midday trading on the NYSE, but are above their 52-week low of $25.60 reached in November.
Sales
The FDA's move comes shortly after Pfizer announced a plan to return to double digit earnings growth by next year, in part by reviving sales from Bextra and Celebrex.
Sales of both drugs went into a freefall last year after being linked to heart problems. Last year, Celebrex sales totaled $3.3 billion while Bextra sales were $1.3 billion.
Analysts had expected sales of both drugs would sink this year because of safety concerns.
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