- The Washington Times - Thursday, December 23, 2004

The Food and Drug Administration yesterday urged the public to limit use of over-the-counter pain medications. The agency also ordered a review of all prevention studies involving drugs such as Celebrex and Bextra, which have been associated with increased risk of heart problems.

“Consumers are advised that all over-the-counter pain medications … should be used in strict accordance with the label directions,” said Dr. John K. Jenkins, FDA director of new drugs.

That means the drugs — including such popular products as Aleve, ibuprofen and even aspirin — should not be used longer than 10 days without consulting a doctor, he said.

Dr. Jenkins said the agency will review dozens of studies now under way in which the so-called Cox-2 inhibitors are being tested as ways to prevent various illnesses.

These drugs, sold by prescription, have been implicated in higher rates of heart problems and stroke. One of them, Merck & Co.’s Vioxx, was pulled from the market by its manufacturer, and the FDA has advised caution in using the others, Pfizer Inc.’s Celebrex and Bextra.

In addition, naproxen, a popular painkiller sold as Aleve and Naprosyn, has been implicated in heart problems in a National Institutes of Health study.

“This is a rapidly evolving area,” Dr. Jenkins said in a telephone briefing, adding that the public health advisory to limit use of these painkillers is an interim measure pending a full review of data on the drugs.

He said the FDA will convene an advisory panel in February to thoroughly study the available information on the drugs.

Painkillers such as aspirin can carry a serious risk of stomach and intestinal bleeding, Dr. Jenkins noted, and doctors must balance this with the potential heart risk of some of the other drugs.

“Physicians prescribing Celebrex or Bextra should consider this emerging information when weighing the benefits against risks for individual patients. Patients who are at a high risk of gastrointestinal bleeding” or “have a history of intolerance” to drugs such as aspirin or ibuprofen may be appropriate candidates for Cox-2 drugs, he said.

The agency is “advising physicians to be very thoughtful as they are prescribing” painkillers, Dr. Jenkins said. “We are clearly suggesting that doctors take into account the new information that’s become available.”

Yesterday, Merck shares rose 8 cents, or 0.2 percent, to close at $32.30 on the New York Stock Exchange. The stock has fallen more than 25 percent since the Vioxx withdrawal in September.

Pfizer shares advanced 12 cents, or 0.5 percent, to close at $26.07 on the NYSE. They are down 10 percent since last week, when the company announced a study had found increased risk of heart problems with Celebrex.

U.S.-traded shares of Bayer AG, manufacturer of heavily advertised Aleve, rose 38 cents, or 1.1 percent, to close at $34.12 on the NYSE — within striking distance of its 52-week high of $34.20.



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