title: A look at the safety profile of over-the-counter naproxen sodium: a meta-analysis.
abstract: As the trend for Americans to self-medicate continues to increase, it becomes important to review the safety of over-the-counter (OTC) medications. This article will review the safety of an OTC analgesic, Aleve (naproxen sodium). The objective of this meta-analysis is to evaluate the frequency of occurrence of all adverse events in subjects taking various doses of OTC naproxen sodium as compared to placebo. These varying doses and dosage regimens were studied individually and consisted of 220 to 880 mg administered in single, multiple, and PRN (as 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 naproxen sodium was comparable and in some cases significantly lower than placebo. These results indicate that treatment with naproxen sodium may be highly beneficial from a clinical and economical perspective and safe when adhering to labeled directions.
authors.affiliation: Bayer Consumer Care, 36 Columbia Road, P.O. Box 1910, Morristown, NJ 07962-1910, USA.
authors.forename: V
authors.initials: V
authors.lastname: Bansal
authors.forename: T
authors.initials: T
authors.lastname: Dex
authors.forename: H
authors.initials: H
authors.lastname: Proskin
authors.forename: S
authors.initials: S
authors.lastname: Garreffa
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D004244:Dizziness / Q000139:chemically induced; D006261:Headache / Q000139:chemically induced; D006801:Humans; D009288:Naproxen / Q000009:adverse effects*; D009325:Nausea / Q000139:chemically induced; D004366:Nonprescription Drugs / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D004366:Nonprescription Drugs; D009288:Naproxen