FDA Orders Review of Pain Drug Studies

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

"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 (search), ibuprofen (search) and even aspirin (search) — should not be used longer than 10 days without consulting a doctor, Jenkins said.

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

These drugs, sold by prescription, have been implicated in higher rates of heart problems and stroke. One of them, Vioxx (search), was pulled from the market by its manufacturer, and the FDA has advised caution in using the others, Celebrex and Bextra.

In addition, naproxen (search), a popular pain killer sold as Aleve and Naprosyn, has also been implicated in heart problems in a National Institutes of Health study.

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

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

Pain killers such as aspirin car carry a serious risk of stomach and intestinal bleeding, 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, have a history of intolerance" to drugs like 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, Jenkins said. "We are clearly suggesting that doctors take into account the new information that's become available."