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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).
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.