A look at the safety profile of over-the-counter naproxen sodium: A meta-analysis

Citation
V. Bansal et al., A look at the safety profile of over-the-counter naproxen sodium: A meta-analysis, J CLIN PHAR, 41(2), 2001, pp. 127-138
Citations number
21
Categorie Soggetti
Pharmacology,"Pharmacology & Toxicology
Journal title
JOURNAL OF CLINICAL PHARMACOLOGY
ISSN journal
00912700 → ACNP
Volume
41
Issue
2
Year of publication
2001
Pages
127 - 138
Database
ISI
SICI code
0091-2700(200102)41:2<127:ALATSP>2.0.ZU;2-N
Abstract
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.