Safety of non-prescription NSAIDs

Background: Regulation of NSAIDS is an area of ongoing controversy, with lower dose preparations and smaller pack sizes available as non-prescription items in many countries. Multiple studies have identified harms associated with the use of NSAIDs, however these studies have focused on prescribed medications, and it is unknown to what extent such harms are evident with non-prescription NSAIDs.
Objectives: The aim of this study was to quantify the risk of adverse gastrointestinal, cardiac and renal outcomes associated with the use of non-prescription NSAIDs.
Methods: Disproportionality analyses using national voluntary reporting data from Australia and Canada were used to detect potential signals of gastrointestinal bleed, cardiovascular and renal adverse effects associated with the use of non-prescription NSAIDs. Outcomes were classified using the Medical Dictionary for Regulatory Activities (MedDRA) terminology and medications were classified using the Anatomical Therapeutic Chemical Classification System (ATC). Non-prescription NSAIDs were identified using relevant brand names in each dataset. Sensitivity analysis was conducted in the ADRS dataset to confirm the robustness of identification of non-prescription NSAIDs. Exposure variables were adjusted for age, gender and relevant confounding risk factors.
Results: Non-prescription NSAIDS were associated with a 100% increase in the risk of GI bleed in both datasets (Australia: Relative Odds Ratio (ROR)=2.847 (95% CI: 2.432 - 3.332), Canada: ROR=2.322 (95% CI: 2.141 – 2.519)). A small but significant increased risk of adverse renal outcomes was observed in both datasets (Australia: ROR=1.240 (95% CI 1.039 – 1.481), Canada: ROR=1.333, (95% CI 1.224 – 1.452)). A small increased risk of adverse cardiovascular outcomes was observed in the Canadian dataset (ROR=1.343 (95% CI: 1.288 – 1.401)), however no increased risk was found in the Australian data.
Conclusions: Considerable risks were associated with the use of non-prescription NSAIDs, despite the availability of lower dose formulations and smaller pack sizes in many markets. These results have implications for both the use and the regulation of NSAIDs, demonstrating that considerable harms may be associated with non-prescription products.