2001
DOI: 10.1177/00912700122009935
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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 adminis… Show more

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Cited by 27 publications
(14 citation statements)
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“…7, 10, 11, 27, 28 Our data show that among participants who report pain, only 11% take opioids, which was significantly less than using non-opioids, such as NSAIDs. In addition, recent clinical trials have shown effectiveness in using opioids for pain among older adults with musculoskeletal conditions.…”
Section: Discussionmentioning
confidence: 69%
“…7, 10, 11, 27, 28 Our data show that among participants who report pain, only 11% take opioids, which was significantly less than using non-opioids, such as NSAIDs. In addition, recent clinical trials have shown effectiveness in using opioids for pain among older adults with musculoskeletal conditions.…”
Section: Discussionmentioning
confidence: 69%
“…Currently, two fixed-dose combinations of an NSAID and a PPI are in development; naproxen/esomeprazole from AstraZeneca [5] and ibuprofen/famotidine from Horizon Therapeutics [6]. While both ibuprofen and naproxen are available in higher, prescription-strength doses as well as lower, OTC doses, the occurrence of adverse GI side effects in patients taking OTC doses of naproxen (up to 660 mg/day) has been shown to be comparable to, and in some cases lower than, the incidence of GI side effects in patients taking placebo [7]. Additionally, while COX-2-specific inhibitors have been linked to an increased risk of CV events [8], naproxen has been shown not to be associated with an increased risk of acute MI [9,10].…”
Section: Discussionmentioning
confidence: 99%
“…NSAIDs relieve short‐term low back pain as well [44,45]. In the general adult population, over‐the‐counter dosing of selected NSAIDs has a good safety profile [46], although older adults are at higher risk for adverse NSAID effects. Particular caution must be exercised when considering NSAID therapy for individuals with low creatinine clearance, gastropathy, cardiovascular disease, or intravascularly depleted states such as congestive heart failure.…”
Section: Pharmacotherapymentioning
confidence: 99%