http://www.healthsentinel.com/news.php?event=news_print_list_item&id=489

"Aleve Tied to Heart Problems", Atlanta Journal - Constitution,
December 20, 2004,
Link:
http://www.ajc.com/health/content/shared-auto/healthnews/arth/523017.html

The U.S. government announced Monday that it is halting the use of the
popular painkiller Aleve in a clinical trial because of patients taking
it had a higher risk of developing heart trouble.

It was the second time in as many workdays that the NIH suspended the
use of an arthritis drug in a trial. On Friday, the agency said it was
stopping the use of Celebrex in a trial on cancer patients.

Monday's announcement centered around a trial testing whether Aleve or
Celebrex could prevent Alzheimer's disease. And while several recent
studies have cast the family of drugs Celebrex belongs to in an
unhealthy light, this is the first in which a trial using an
over-the-counter arthritis drug was known to cause trouble.

Aleve and Celebrex are different types of nonsteroidal inflammatory
inhibitors (NSAIDs). Celebrex and two other drugs that have been tied
to heart trouble this year, Vioxx and Bextra, belong to a subset of
stomach-friendly NSAIDs called cox-2 inhibitors.

Although participants in the Alzheimer's trial will no longer be taking
either Aleve or Celebrex (celecoxib), they will continue to be
monitored.

"We are suspending the use of the drugs within this trial," Dr. Elias
Zerhouni, director of the National Institutes of Health, said at a news
conference Monday evening. "The trial itself is not suspended and will
continue."

Aleve (brand name naproxen) belongs to an older family of drugs known
as cox-1 inhibitors.

The cox-2 class of drugs has fallen under a dark cloud. In September,
Vioxx was pulled from the market due to an increased incidence of
cardiovascular problems. Then on Friday, a trial involving another
cox-2, Celebrex, was halted due to similar concerns among colorectal
cancer patients. A third cox-2 inhibitor, Bextra, has also shown
evidence of problems.

In the wake of the cox-2 revelations, many people had turned to the
older cox-1 inhibitors for pain management. Naproxen has been on the
market as a prescription drug since 1976 and as a lower-dose,
over-the-counter drug (Aleve) since 1994.

The current trial, sponsored by the National Institute on Aging, was
trying to determine if NSAIDs might have a preventive effect on
Alzheimer's. About 2,500 participants were divided into three groups
and randomly assigned to receive either 220 mg of naproxen twice a day,
200 mg of Celebrex twice a day, or a placebo, for up to three years.

Investigators had noticed a "weak signal" towards cardiovascular events
in the naproxen arm, but also decided to suspend the use of drugs after
the news about Celebrex broke last week.

"The events of last week and the news about celecoxib put things into a
different light for us, because in part we found it very difficult to
ask our participants to continue to stay on treatments when they knew
that they had a chance of receiving Celebrex, about which there has
been a lot of adverse publicity of late," said Dr. John Breitner,
principal investigator of the study who is with the Veterans Affairs
Medical Center and the University of Washington, both in Seattle.

Breitner said that the research team had noticed a 50 percent increased
risk of cardiovascular events in naproxen patients, but cautioned that
these were "small numbers." In all, 70 patients in the trial
experienced heart attacks or strokes, out of a total of 2,500 people.
There were about 23 deaths, about equally distributed across the three
groups. In all, the risks did not approach those seen last week with
Celebrex, Breitner added.

All of the participants were called over the weekend and instructed not
to take any more medication.

Officials from the U.S. Food and Drug Administration (FDA) said the
agency would assess what regulatory actions would be appropriate.
"Suspending a research trial where a benefit is only potential in
nature is very different from making a decision about whether a drug
should stay on the market," Zerhouni stated.

"FDA advises patients who are currently taking over-the-counter
naproxen to carefully follow the instructions on the label," said Dr.
Steven Galson, head of the FDA's Center for Drug Evaluation and
Research. "Patients should not exceed the recommended doses for
naproxen, and no longer than 10 days."

Naproxen is also contained in prescription products, Galson added.
Individuals taking these products should consult with their physicians.