FDA Orders Review of All Prevention Studies
Involving So-Called Cox-2 Inhibitors

Thursday, December 23, 2004

WASHINGTON --  The Food and Drug Administration
on Thursday ordered a review of all prevention
studies involving drugs such as Celebrex and
Bextra, 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, ibuprofen and even aspirin _
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 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, was pulled from the
market by its manufacturer, and the FDA has
advised caution in using the others, Celebrex
and Bextra.

In addition, naproxen, 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."
               ___
On the Net:
Food and Drug Administration: http://www.fda.gov

]