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The availability of analgesics and non-steroidal anti-inflammatory drugs (NSAIDs) sold over-the-counter (OTC) to the public without prescription has become an issue of major concern in recent years. The problem has been highlighted in the UK, USA and other countries because of the continuing high rates of cases of poisoning and the influence of switching from prescription-only status for many NSAIDs to OTC sale brought about, in a large part, by governments and health maintenance organisations (especially in the USA) anxious to save on costs of these drugs. Concern in the UK about poisoning from paracetamol and the appreciable morbidity and mortality from aspirin was such that a major review was initiated in 1996 by the UK government's Medicines Control Agency (MCA). Doubtless, many other governments have also undertaken reviews of the safety issues concerning OTC analgesics and NSAIDs. In the UK the situation has culminated in the decision announced in August 1997, as this book was going to press, that the number of tablets/capsules of the solid dosage forms of paracetamol and aspirin would be limited for sale OTe. This decision was essentially based on the need to limit the unit quantity of these drugs so as to reduce the likelihood of poisoning with paracetamol and the development of gastrointestinal and other more serious side-effects from aspirin. Time. will tell whether these new regulations will influence the occurrence of these adverse events.
Sommario
1. Current status of issues concerning the safety of over-the-counter analgesics and nonsteroidal anti-inflammatory drugs.- 2. Review of published clinical trial data on the adverse reactions from ibuprofen and paracetamol/acetaminophen at OTC dosages.- 3. Adverse drug reactions in the gastrointestinal system attributed to ibuprofen.- 4. The epidemiology of non-gastrointestinal adverse reactions from OTC analgesics.- 5. Renal safety of ibuprofen: pharmacokinetic aspects.- 6. Therapeutic considerations from pharmacokinetics and metabolism: ibuprofen and paracetamol.- 7. Acute human toxicity from NSAIDs and analgesics.- 8. Regulatory considerations concerning safety of OTC NSAIDs and analgesics.- 9. Evaluation of analgesic mechanisms and NSAIDs for acute pain using the oral surgery model.- 10. Multicentre study of the efficacy of ibuprofen compared with paracetamol in throat pain associated with tonsillitis.- 11. Ibuprofen plus caffeine in the treatment of migraine.- DEBATE - Safety and efficacy issues with OTC analgesics/NSAIDs Chair: KD Rainsford. Panel: Above contributors and WW Buchanan, BA Callingham, N Bellamy, DE Furst.
Riassunto
Proceedings of the International Conference, San Francisco, CA, USA
