As the trend for Americans to self-medicate continues to increase, if becom
es important to review the safety of over-the-counter (OTC) medications. Th
is article will review the safety of an OTC analgesic, Aleve(R) (naproxen s
odium). The objective of this meta-analysis is to evaluate the frequency of
occurrence of all adverse events in subjects taking various doses of OTC n
aproxen sodium as compared to placebo. These varying doses and dosage regim
ens were studied individually and consisted of 220 to 880 mg administered i
n single, multiple, and PRN las needed) doses of naproxen sodium. This meta
-analysis confirmed the favorable safety profile of naproxen sodium at OTC
doses and established that the overall occurrence of adverse events with na
proxen sodium was comparable and in some cases significantly lower than pla
cebo. These results indicate that treatment with naproxen sodium may be hig
hly beneficial from a clinical and economical perspective and safe when adh
ering to labeled directions. (C) 2001 the American College of Clinical Phar
macology.