Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the most widely used classes of drug worldwide, with as many as 8% of the global adult population taking prescription NSAIDs at any given time. It is well documented that NSAID-related gastrointestinal (GI) effects are a significant cause of morbidity and mortality. Data from Australia alone suggest that each year there may be as many as 2300 serious GI complications and 300 deaths. Risk factors for NSAID-related GI complications have been established and can be broadly divided into two groups: uncontrollable factors, which include elements such as age, gender, comorbidity, and a history of GI conditions, and controllable factors, such as the dose, type, and duration of NSAID treatment and cotherapy and possibly Helicobacter pylori infection. The increasing trend toward self-medication raises questions about the potential for GI complications with OTC doses of NSAIDs. Although there is some evidence that the frequency of GI complications with OTC doses may be less than that seen with prescription doses, it still exists. At present, there is insufficient evidence to determine the population attributable risk associated with their widespread use. Emerging data and factors that confound their interpretation are discussed. Given that the data are limited, a clear picture of the true extent of GI complications with OTC NSAIDs is not yet available. In light of our current understanding and because paracetamol continues to demonstrate a favorable side-effect profile, it remains a first-line analgesic for everyday pain.
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