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Naproxen (Aleve, Anaprox, Naprelan, Naprosyn, generic) cardiovascular risk
December 21, 2004
Naproxen 220 mg twice a day showed an increase risk of cardiovascular events compared to placebo in a study investigating therapies to prevent Alzheimer’s disease. A CNN news report indicated a 50% increase in cardiovascular events in the naproxen group compared to the placebo group. No data were available from other sources. This study also included a celecoxib (Celebrex) group (200 mg twice a day) which did not show an increase risk of cardiovascular events. This study has been suspended and the data are being evaluated by the FDA. The FDA recommends using the lowest dose possible of naproxen and not to exceed 10 days of use. Naproxen (Aleve) is available over-the-counter.
Additional information is available at the following links:
- FDA statement:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2004/ucm108387.htm - MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm155478.htm - NIH News:
http://www.nih.gov/news/pr/dec2004/od-20.htm - Clinical Trials Information:
http://www.clinicaltrials.gov/ct/show/NCT00007189?order=1
Updated
December 21, 2004; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
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