Another good drug pulled

I have found this drug works well for so many people. There it goes....

U.S. Issues Strong Warnings on Popular Painkillers; Pfizer Pulls Bextra

(International Herald Tribune)
U.S. drug regulators have issued sweeping warnings that many popular painkillers could hurt the heart, stomach and skin, and they have persuaded Pfizer to withdraw its pain pill Bextra, once a strong seller.

Tough warnings about heart risks will soon dominate the labels for prescription painkillers like Celebrex, Mobic, Naprosyn, Voltaren and more than a dozen other similar drugs, the Food and Drug Administration announced Thursday. Even the labels of popular over-the-counter pills like Advil and Aleve will have to cite risks to heart, stomach and skin, the agency said.

Few studies have examined the long-term health effects of most of these medicines, so regulators are in part groping in the dark. Studies done on Bextra and Celebrex, both from Pfizer, and Vioxx, made by Merck, strongly suggest that they increase the risks of heart attacks and strokes. With those studies in hand and suggestions that older drugs may act similarly, agency officials said that they could not rule out the notion that all of the drugs in the class known as nonsteroidal anti-inflammatories cause similar problems.

"We think these risks apply to all of these drugs," said Steven Galson, acting director of the agency's center for drugs. "There may be some differences, but our conclusion is that we don't have enough data to rank order these risks."

Still, Galson emphasized, popular over-the-counter pain pills are safe if taken briefly and in low doses, and patients should not suddenly stop taking these medicines because of the announcement. Several experts said that naproxen, the medicine found in Naprosyn and Aleve, is probably the safest among the nonsteroidal pain pills.

Neither Tylenol nor aspirin are affected by the new warnings, although those medicines are not problem-free. In high doses, aspirin can hurt the stomach and Tylenol can damage the liver. Aspirin, though, protects the heart. The latest warnings will complicate prescribing decisions for arthritis patients and other patients in chronic pain. Pfizer said that it "respectfully disagrees with FDA's position regarding the overall risk/benefit profile of Bextra," but it agreed to suspend sales of the drug. The company said it would work with the agency to come up with a strongly worded warning for Celebrex.

Pfizer has agreed to undertake a large study of Celebrex's effects on the heart, the agency said. The agency has asked manufacturers of other pain pills to re-evaluate studies of their pills' effects on the heart. The agency has no authority to force drug makers to undertake trials of approved medicines.

Celebrex, Bextra and Vioxx were, as recently as last year, among the top-selling drugs in the world. All are part of a new class of drugs called COX-2 inhibitors that were supposed to be safer on the stomach than older pain pills. But Celebrex and Bextra never proved to be any safer to the stomach, and none of the three drugs alleviate pain any better than do older ones.

In February, the agency asked a committee of experts whether it should force the withdrawal of Bextra and Celebrex and keep Vioxx off the market. The committee voted overwhelmingly that Celebrex was safe but only narrowly supported continued sales of Bextra and Vioxx. Galson said the agency's decision to press Pfizer to withdraw Bextra was "consistent with the views of many people on the panel."

The agency's announcement was yet another blow to Pfizer, which on Tuesday assured Wall Street that sales of Celebrex and Bextra would soon rebound. It was the latest in a string of Pfizer announcements on the two drugs that quickly proved untrue

 

So should one be worried if they took Bextra in the past?