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Relative safety of NSAIDs and analgesics for non-prescription use or in equivalent doses

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image of Inflammopharmacology

The relative safety of some new compared with established NSAIDs and the non-prescription ('over the counter') NSAIDs, naproxen and ketoprofen, compared with ibuprofen, paracetamol and aspirin is analysed from published reports of randomized and controlled clinical trials. This analysis arose from (a) recent considerations in some countries of the possibility of switching prescription-only NSAIDs to OTC status, and (b) the use of prescription NSAIDs in some countries instead of those available OTC analgesics/NSAIDs for minor acute conditions (such as upper respiratory tract, ENT, and acute painful states) so raising the issue about relative safety in acute conditions of both OTC compared with prescription drugs used to control pain and inflammation.

Using our previously reported selection criteria (Rainsford et al., 1997) data from published studies on the effects of ketoprofen and naproxen at OTC dosages used for treatment of pain and inflammation were analysed for adverse reactions. Similarly, studies on the paediatric use of ibuprofen were compared with those of paracetamol and aspirin.

Some issues concerning the statistics of relatively small numbers of adverse reactions in relation to total numbers of study subjects are highlighted from this data analysis. Despite these limitations it has been possible to conclude that ketoprofen and naproxen at OTC doses cause minor (non-serious) adverse reactions that are probably reversible on cessation of these drugs. With ketoprofen these adverse reactions appear more prevalent in subjects undergoing dental surgery or in rheumatic patients compared with those taking these drugs for headache. Paediatric use of ibuprofen results mostly in mild GI symptoms and these appear reversible upon cessation of the drug.


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