Naproxen - FDA Statement on halting of NIH clinical trial

[Brian, ASN, RN]

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA announced that it was reviewing 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. 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.

Read the MedWatch 2004 safety summary, including a link to the FDA Statement

at:

http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#Naproxen