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FDA Issues Advice on Use of Naproxen
(Aleve) After Trial Halt
Dec. 21, 2004 - The FDA today released the
following statement containing advice to senior citizens and others on
the halting of the use of Aleve (naproxen) in a clinical trial involving
non-steroidal anti-inflammatory drugs in elderly patients at risk of
developing Alzheimer's Disease.
“The Food and Drug Administration (FDA) is working
with the National Institutes of Health to review the available
scientific information on naproxen following the decision of the
National Institute on Aging to halt a clinical trial studying
non-steroidal anti-inflammatory drugs in patients at risk of developing
Alzheimer's disease. Preliminary information from the study showed some
evidence of increased risk of cardiovascular events, when compared to
placebo, to patients taking naproxen,” said the statement by FDA.
“In the meantime, FDA advises patients who are
currently taking over-the-counter naproxen products to carefully follow
the instructions on the label.
“Patients should not exceed the recommended doses
for naproxen (220 milligrams twice daily) and should not take naproxen
for longer than ten days unless a physician directs otherwise.
“Patients with questions about naproxen should
consult their physicians.
“Naproxen was first sold as a prescription drug
under the trade name Naprosyn in 1976. FDA approved its use as an
over-the-counter drug in 1994.”
Link to Previous Story Below
Aleve Suspended in Clinical Trial Due to Increased
Heart Risk
Celebrex also suspended, although no problems seen in
this trial
Dec. 21, 2004 – The use of Aleve and Celebrex was
suspended yesterday by the National Institutes of Health in a national
Alzheimer’s disease prevention trial, which involved senior citizens 70
and older who were considered at increased risk of AD. The researchers
say use of Aleve (naproxen) at 220 mg twice a day indicated an “apparent
increase in cardiovascular and cerebrovascular events” in the elderly
participants. There was no problem found with Celebrex (celecoxib) at
200 mg twice a day, but this drug was suspended due to problems noted in
other trials. More...
12/21/04*
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