Aleve Latest Drug to Draw Scrutiny <- WHATTHEHECK ARE WE SUPPOSED TO TAKE?

From: JOE (am_at_rem_sae.biz)
Date: 12/21/04 

Date: Tue, 21 Dec 2004 08:50:54 -0600

December 21, 2004
Aleve Latest Drug to Draw Scrutiny
By THE ASSOCIATED PRESS

WASHINGTON (AP) -- An Alzheimer's disease prevention trial was
suspended after researchers said there were more heart attacks and
strokes among patients taking naproxen, an over-the-counter pain
reliever in use for 28 years and commonly known under the brand name
Aleve.

The study, involving some 2,500 patients, was to test whether naproxen
or Celebrex, both pain relievers, could reduce the risk of Alzheimer's
disease among healthy elderly patients who were at an increased risk
of the disease.

Officials at the National Institutes of Health said the study was
suspended after three years when it was found that patients taking
naproxen had a 50 percent greater incidence of cardiovascular events
-- heart attack or stroke -- than patients taking placebo.

Another factor, officials said, was the announcement last week that
advertising for Celebrex was being halted after a study found that
high doses of the drug were associated with an increase in heart
attack risk. Preliminary data from the Alzheimer's study, however, did
not indicate an increased risk for heart attack or stroke for
Celebrex, officials said.

Lester Crawford, acting commissioner of the Food and Drug
Administration, acknowledged Tuesday that the conflicting studies are
confusing and call for continued evaluation. For now, he recommended
following the dosage recommendations for the drugs.

``Any drug taken long enough and at high enough dosage can cause some
difficulty,'' Crawford said on NBC's ``Today.''

``It would be premature to say what we we're going to do with either
one of these drugs, Celebrex or Aleve,'' he said. ``However, we will
keep all regulator options open and make some determinations as
quickly as possible based on the data.''

Celebrex, a prescription drug, and naproxen are both commonly used to
treat the joint pain of arthritis. Naproxen has been approved for
sale, first as a prescription and then as an over-the-counter drug,
since 1976. Celebrex is in the same class -- COX2 enzyme inhibitors --
as Vioxx, an arthritis drug recently taken off the market by its
manufacturer after it was linked to an increase in heart attack and
stroke.

Officials acknowledged that the implications for the continued use of
naproxen are not clear and will require further study.

Dr. Sandra Kweder of the FDA said the NIH study is the first to show
that naproxen might increase the risk of heart attack or stroke and
that the findings are ``confusing.'' No immediate action, however, is
expected toward naproxen, she said.

``We are not contemplating any specific regulatory action over the
next few days,'' Kweder said. ``We will be working with the NIH to try
to understand the data better and determine what will be appropriate
from there.''

Patients who routinely take naproxen should follow the drug package
instructions carefully, Kweder said, including the directions to not
take it for more than 10 days, and to consult a doctor if pain
persists.

Efforts to obtain reaction Monday night produced no answers at phone
numbers for Bayer Healthcare, the maker of Aleve.

In the earlier studies of the COX2 drugs, an increase in
cardiovascular events was noted only after a long-term use of the
medications.

The Alzheimer's disease study was being conducted by the National
Institute on Aging, an arm of the NIH. It called for 2,500 patients
aged 70 or older and who had a family history of Alzheimer's, to take
either Celebrex, naproxen or a placebo.

The group was divided and each division, or arm, was assigned to
receive one of the drugs or placebo. The drugs were blinded, which
means the patients did not know which medication they were taking, or
if they were taking a placebo.

The goal was to determine if the pain-relieving drugs lowered the risk
of developing Alzheimer's disease. The study started three years ago
and was to continue for a few more years. Officials said the patients
in the study will be monitored for developing Alzheimer's or cognitive
decline, but will not be given the test drugs.

Dr. Elias A. Zerhouni, the director of the National Institutes of
Health, said the study linking heart attack to Celebrex last week was
a major factor in deciding to suspend the Alzheimer's study.

He said there was a question whether patients in the study would
continue to take their medicine since they knew they might be taking
Celebrex.

Suspending the study, Zerhouni said, ``is the prudent thing to do.''

John Breitner of the Veterans Affairs medical facility in Seattle and
the University of Washington, an investigator in the trial, said only
preliminary data is available. But he said it suggests that among the
2,500 patients in the study, about 70 suffered stroke or heart attack.
There were 23 deaths. There were 50 percent more of the cardiovascular
events among patients taking naproxen than among those taking placebo,
he said.

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On the Net:

National Institutes of Health: http://www.nih.gov

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