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Expert Opin Drug Saf. 2014 Feb;13(2):167-79. doi: 10.1517/14740338.2014.846324. Epub 2013 Nov 21.

Cardiovascular risks associated with low-dose ibuprofen and diclofenac as used OTC.

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Université Bordeaux Segalen, Department of Pharmacology , 146 Rue Leo Saignat, 33076 Bordeaux , France +33 0 557571560 ; +33 0 557574671 ;



The cardiovascular (CV) risks of non-steroidal anti-inflammatory drugs (NSAIDs) are dose- and duration-dependent. As over-the-counter (OTC) NSAIDs are widely used for the treatment of common painful disorders, without medical supervision, their cardiovascular risks need to be assessed.


Individual clinical trials and observational studies of the CV risks associated with NSAIDs and meta-analyses thereof were retrieved and analysed. The article focuses on the risk associated with low-dose ibuprofen and diclofenac, two drugs available OTC in many countries. Very few studies reported on dose-related CV risks of NSAIDs. The usual cut-off for low-dose ibuprofen was 1200 mg daily, the upper limit of the approved OTC daily dose. For diclofenac, the usual cut-off was 100 mg, 33% above the approved daily dose for OTC preparations (75 mg/day). Only one study reported on the CV risks of doses at or below this limit. The studies retrieved found a clear dose-dependent risk with both drugs and no clearly increased cardiovascular risk for doses at or below the maximal approved OTC doses. No study looked at actual OTC usage.


At doses below the maximal daily OTC dose and for durations associated with OTC usage, there was no clear association with increased CV risk.

[Indexed for MEDLINE]

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