Gastrointestinal safety and tolerability of oral non-aspirin over-the-counter analgesics

References

• Moore N. Place of OTC analgesics and NSAIDs in osteoarthritis. Inflammopharmacology. 2003;11(4):355–362. Epub 2004/03/24.
   PubMedGoogle Scholar
• Duong M, Salvo F, Pariente A, et al. Usage patterns of ‘over-the-counter’ vs. prescription-strength nonsteroidal anti-inflammatory drugs in France. Br J Clin Pharmacol. 2014;77(5):887–895.
   PubMed Web of Science ®Google Scholar
• Moore N, Vanganse E, Lepare J-M, et al. The PAIN study: paracetamol, aspirin and ibuprofen new tolerability study: a large-scale, randomised clinical trial comparing the tolerability of aspirin, ibuprofen and paracetamol for short-term analgesia. Clin Drug Investig. 1999;18(2):89–98.
   Web of Science ®Google Scholar
• Duong M, Gulmez SE, Salvo F, et al. Usage patterns of paracetamol in France. Br J Clin Pharmacol. 2016;82(2):498–503. Epub 2016/04/10.
   PubMed Web of Science ®Google Scholar
• Moore RA, Wiffen PJ, Derry S, et al. Non-prescription (OTC) oral analgesics for acute pain - an overview of Cochrane reviews. Cochrane Database Syst Rev. 2015;(11):CD010794. Epub 2015/11/07.
   PubMed Web of Science ®Google Scholar
• da Costa BR, Reichenbach S, Keller N, et al. Effectiveness of non-steroidal anti-inflammatory drugs for the treatment of pain in knee and hip osteoarthritis: a network meta-analysis. Lancet. 2016;387(10033):2093–2105. Epub 2016/03/22.
   PubMed Web of Science ®Google Scholar
• Moore RA, Derry S, Wiffen PJ, et al. Overview review: comparative efficacy of oral ibuprofen and paracetamol (acetaminophen) across acute and chronic pain conditions. Eur J Pain. 2015;19(9):1213–1223.
   PubMed Web of Science ®Google Scholar
• Bailey E, Worthington HV, Van Wijk A, et al. Ibuprofen and/or paracetamol (acetaminophen) for pain relief after surgical removal of lower wisdom teeth. Cochrane Database Syst Rev. 2013;12:CD004624.
   Google Scholar
• Cooper SA, Schachtel BP, Goldman E, et al. Ibuprofen and acetaminophen in the relief of acute pain: a randomized, double-blind, placebo-controlled study. J Clin Pharmacol. 1989;29(11):1026–1030.
   PubMed Web of Science ®Google Scholar
• Castellsague J, Riera-Guardia N, Calingaert B, et al. Individual NSAIDs and upper gastrointestinal complications: a systematic review and meta-analysis of observational studies (the SOS project). Drug Saf. 2012;35(12):1127–1146.
   PubMed Web of Science ®Google Scholar
• Gutthann SP, Garcia Rodriguez LA, Raiford DS. Individual nonsteroidal antiinflammatory drugs and other risk factors for upper gastrointestinal bleeding and perforation. Epidemiology. 1997;8(1):18–24.
   PubMed Web of Science ®Google Scholar
• Van Oijen MG, Dieleman JP, Laheij RJ, et al. Peptic ulcerations are related to systemic rather than local effects of low-dose aspirin. Clin Gastroenterol Hepatol. 2008;6(3):309–313. Epub 2008/02/05.
   PubMed Web of Science ®Google Scholar
• Scheiman JM. NSAID-induced gastrointestinal injury: a focused update for clinicians. J Clin Gastroenterol. 2016;50(1): 5–10. Epub 2015/11/03.
   PubMed Web of Science ®Google Scholar
• Lichtenberger LM. Where is the evidence that cyclooxygenase inhibition is the primary cause of nonsteroidal anti-inflammatory drug (NSAID)-induced gastrointestinal injury? Topical injury revisited. Biochem Pharmacol. 2001;61(6):631–637.
   PubMed Web of Science ®Google Scholar
• Somasundaram S, Rafi S, Hayllar J, et al. Mitochondrial damage: a possible mechanism of the “topical” phase of NSAID induced injury to the rat intestine. Gut. 1997;41(3):344–353.
   PubMed Web of Science ®Google Scholar
• Somasundaram S, Hayllar H, Rafi S, et al. The biochemical basis of non-steroidal anti-inflammatory drug-induced damage to the gastrointestinal tract: a review and a hypothesis. Scand J Gastroenterol. 1995;30(4):289–299.
   PubMed Web of Science ®Google Scholar
• Moore A, Bjarnason I, Cryer B, et al. Evidence for endoscopic ulcers as meaningful surrogate endpoint for clinically significant upper gastrointestinal harm. Clin Gastroenterol Hepatol. 2009;7(11):1156–1163.
   PubMed Web of Science ®Google Scholar
• Motola G, Russo F, Mazzeo F, et al. Over-the-counter oral nonsteroidal anti-inflammatory drugs: a pharmacoepidemiologic study in southern Italy. Adv Ther. 2001;18(5):216–222. Epub 2002/01/11.
   PubMed Web of Science ®Google Scholar
• Lewis JD, Kimmel SE, Localio AR, et al. Risk of serious upper gastrointestinal toxicity with over-the-counter nonaspirin nonsteroidal anti-inflammatory drugs. Gastroenterology. 2005;129(6):1865–1874.
   PubMed Web of Science ®Google Scholar
• Singh G. Gastrointestinal complications of prescription and over-the-counter nonsteroidal anti-inflammatory drugs: a view from the ARAMIS database. Arthritis, Rheumatism, and Aging Medical Information System. Am J Ther. 2000;7(2): 115–121. Epub 2001/04/25.
   PubMedGoogle Scholar
• Fries JF, Bruce B. Rates of serious gastrointestinal events from low dose use of acetylsalicylic acid, acetaminophen, and ibuprofen in patients with osteoarthritis and rheumatoid arthritis. J Rheumatol. 2003;30(10):2226–2233.
   PubMed Web of Science ®Google Scholar
• Moore N, Charlesworth A, Van Ganse E, et al. Risk factors for adverse events in analgesic drug users: results from the PAIN study. Pharmacoepidemiol Drug Saf. 2003;12(7):601–610.
   PubMed Web of Science ®Google Scholar
• Garcia Rodriguez LA, Hernandez-Diaz S. Risk of uncomplicated peptic ulcer among users of aspirin and nonaspirin nonsteroidal antiinflammatory drugs. Am J Epidemiol. 2004;159(1): 23–31. Epub 2003/12/25.
   PubMed Web of Science ®Google Scholar
• Doyle G, Furey S, Berlin R, et al. Gastrointestinal safety and tolerance of ibuprofen at maximum over-the-counter dose. Aliment Pharmacol Ther. 1999;13(7):897–906.
   PubMed Web of Science ®Google Scholar
• Kellstein DE, Waksman JA, Furey SA, et al. The safety profile of nonprescription ibuprofen in multiple-dose use: a meta-analysis. J Clin Pharmacol. 1999;39(5):520–532.
   PubMed Web of Science ®Google Scholar
• Lewis SC, Langman MJ, Laporte JR, et al. Dose-response relationships between individual nonaspirin nonsteroidal anti-inflammatory drugs (NANSAIDs) and serious upper gastrointestinal bleeding: a meta-analysis based on individual patient data. Br J Clin Pharmacol. 2002;54(3):320–326.
   PubMed Web of Science ®Google Scholar
• van der Linden MW, van der Bij S, Welsing P, et al. The balance between severe cardiovascular and gastrointestinal events among users of selective and non-selective non-steroidal anti-inflammatory drugs. Ann Rheum Dis. 2009;68(5):668–673.
   PubMed Web of Science ®Google Scholar
• Doherty M, Hawkey C, Goulder M, et al. A randomised controlled trial of ibuprofen, paracetamol or a combination tablet of ibuprofen/paracetamol in community-derived people with knee pain. Ann Rheum Dis. 2011;70(9):1534–1541. Epub 2011/08/02.
   PubMed Web of Science ®Google Scholar
• Lanza FL, Codispoti JR, Nelson EB. An endoscopic comparison of gastroduodenal injury with over-the-counter doses of ketoprofen and acetaminophen. Am J Gastroenterol. 1998;93(7): 1051–1054. Epub 1998/07/22.
   PubMed Web of Science ®Google Scholar
• Moore N, Vuillemin N, Abiteboul M, et al. Large scale safety study of ketoprofen 25 mg (Toprec) in febrile and painful conditions. Pharmacoepidemiol Drug Saf. 1996;5(5):295–302. Epub 1996/09/01.
   PubMedGoogle Scholar
• DeArmond B, Francisco CA, Lin JS, et al. Safety profile of over-the-counter naproxen sodium. Clin Ther. 1995;17(4):587–601. discussion 586. Epub 1995/07/01.
   PubMed Web of Science ®Google Scholar
• Bansal V, Dex T, Proskin H, et al. A look at the safety profile of over-the-counter naproxen sodium: a meta-analysis. J Clin Pharmacol. 2001;41(2):127–138. Epub 2001/02/24.
   PubMed Web of Science ®Google Scholar
• Bhala N, Emberson J, Merhi A, et al. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013;382(9894):769–779.
   PubMed Web of Science ®Google Scholar
• Moore N. Diclofenac potassium 12.5mg tablets for mild to moderate pain and fever: a review of its pharmacology, clinical efficacy and safety. Clin Drug Investig. 2007;27(3): 163–195. Epub 2007/02/20.
   PubMed Web of Science ®Google Scholar
• Hinz B, Cheremina O, Brune K. Acetaminophen (paracetamol) is a selective cyclooxygenase-2 inhibitor in man. Faseb J. 2008;22(2): 383–390. Epub 2007/09/22.
   PubMed Web of Science ®Google Scholar
• Hogestatt ED, Jonsson BA, Ermund A, et al. Conversion of acetaminophen to the bioactive N-acylphenolamine AM404 via fatty acid amide hydrolase-dependent arachidonic acid conjugation in the nervous system. J Biol Chem. 2005;280(36):31405–31412. Epub 2005/07/01.
   PubMed Web of Science ®Google Scholar
• Bannwarth B. Gastrointestinal safety of paracetamol: is there any cause for concern? Expert Opin Drug Saf. 2004;3(4):269–272.
   PubMedGoogle Scholar
• Boureau F, Schneid H, Zeghari N, et al. The IPSO study: ibuprofen, paracetamol study in osteoarthritis. A randomised comparative clinical study comparing the efficacy and safety of ibuprofen and paracetamol analgesic treatment of osteoarthritis of the knee or hip. Ann Rheum Dis. 2004;63(9):1028–1034.
   PubMed Web of Science ®Google Scholar
• Hersh EV, Levin LM, Cooper SA, et al. Ibuprofen liquigel for oral surgery pain. Clin Ther. 2000;22(11):1306–1318.
   PubMed Web of Science ®Google Scholar
• Rampal P, Moore N, van Ganse E, et al. Gastrointestinal tolerability of ibuprofen compared with paracetamol and aspirin at over-the-counter doses. J Int Med Res. 2002;30(3):301–308.
   PubMed Web of Science ®Google Scholar
• Garcia Rodriguez LA, Hernandez-Diaz S. Relative risk of upper gastrointestinal complications among users of acetaminophen and nonsteroidal anti-inflammatory drugs. Epidemiology. 2001;12(5): 570–576. Epub 2001/08/16.
   PubMed Web of Science ®Google Scholar
• Maes M, Vinken M, Jaeschke H. Experimental models of hepatotoxicity related to acute liver failure. Toxicol Appl Pharmacol. 2016;290: 86–97. Epub 2015/12/04.
   PubMed Web of Science ®Google Scholar
• Rostom A, Goldkind L, Laine L. Nonsteroidal anti-inflammatory drugs and hepatic toxicity: a systematic review of randomized controlled trials in arthritis patients. Clin Gastroenterol Hepatol. 2005;3(5): 489–498. Epub 2005/05/10.
   PubMed Web of Science ®Google Scholar
• Aithal GP, Day CP. Nonsteroidal anti-inflammatory drug-induced hepatotoxicity. Clin Liver Dis. 2007;11(3): 563-575, vi-vii. Epub 2007/08/29.
   PubMedGoogle Scholar
• Perez Gutthann S, Garcia Rodriguez LA. The increased risk of hospitalizations for acute liver injury in a population with exposure to multiple drugs. Epidemiology. 1993;4(6): 496–501. Epub 1993/11/01.
   PubMed Web of Science ®Google Scholar
• Garcia Rodriguez LA, Williams R, Derby LE, et al. Acute liver injury associated with nonsteroidal anti-inflammatory drugs and the role of risk factors. Arch Intern Med. 1994;154(3):311–316. Epub 1994/02/14.
   PubMedGoogle Scholar
• Carson JL, Strom BL, Duff A, et al. Safety of nonsteroidal anti-inflammatory drugs with respect to acute liver disease. Arch Intern Med. 1993;153(11):1331–1336. Epub 1993/06/14.
   PubMedGoogle Scholar
• Lanza LL, Walker AM, Bortnichak EA, et al. Incidence of symptomatic liver function abnormalities in a cohort of NSAID users. Pharmacoepidemiol Drug Saf. 1995;4(4):231–237.
   Google Scholar
• Rubenstein JH, Laine L. Systematic review: the hepatotoxicity of non-steroidal anti-inflammatory drugs. Aliment Pharmacol Ther. 2004;20(4): 373–380. Epub 2004/08/10.
   PubMed Web of Science ®Google Scholar
• Gulmez SE, Larrey D, Pageaux GP, et al. Transplantation for acute liver failure in patients exposed to NSAIDs or paracetamol (acetaminophen): the multinational case-population SALT study. Drug Saf. 2013;36(2):135–144. Epub 2013/01/18.
   PubMed Web of Science ®Google Scholar
• Herndon CM, Dankenbring DM. Patient perception and knowledge of acetaminophen in a large family medicine service. J Pain Palliat Care Pharmacother. 2014;28(2): 109–116. Epub 2014/05/13.
   PubMedGoogle Scholar
• Blieden M, Paramore LC, Shah D, et al. A perspective on the epidemiology of acetaminophen exposure and toxicity in the United States. Expert Rev Clin Pharmacol. 2014;7(3):341–348. Epub 2014/04/01.
   PubMed Web of Science ®Google Scholar
• Larson AM, Polson J, Fontana RJ, et al. Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study. Hepatology. 2005;42(6):1364–1372.
   PubMed Web of Science ®Google Scholar
• Watkins PB, Kaplowitz N, Slattery JT, et al. Aminotransferase elevations in healthy adults receiving 4 grams of acetaminophen daily: a randomized controlled trial. Jama. 2006;296(1):87–93.
   PubMed Web of Science ®Google Scholar
• Dart RC, Bailey E. Does therapeutic use of acetaminophen cause acute liver failure? Pharmacotherapy. 2007;27(9): 1219–1230. Epub 2007/08/29.
   PubMed Web of Science ®Google Scholar
• Bradley JD, Brandt KD, Katz BP, et al. Comparison of an antiinflammatory dose of ibuprofen, an analgesic dose of ibuprofen, and acetaminophen in the treatment of patients with osteoarthritis of the knee. N Engl J Med. 1991;325(2):87–91.
   PubMed Web of Science ®Google Scholar
• Bronstein AC, Spyker DA, Cantilena LR Jr., et al. 2009 annual report of the American Association of Poison Control Centers’ national poison data system (NPDS): 27th annual report. Clin Toxicol (Phila). 2010;48(10):979–1178. Epub 2011/01/05.
   PubMed Web of Science ®Google Scholar
• Volans G, Monaghan J, Colbridge M. Ibuprofen overdose. Int J Clin Pract Suppl. 2003;57(35):54–60.
   PubMedGoogle Scholar
• Hall AH, Smolinske SC, Conrad FL, et al. Ibuprofen overdose: 126 cases. Ann Emerg Med. 1986;15(11):1308–1313.
   PubMed Web of Science ®Google Scholar
• Rainsford KD. Ibuprofen: from invention to an OTC therapeutic mainstay. Int J Clin Pract Suppl. 2013;67(178):9–20.
   PubMedGoogle Scholar
• Hall AH, Smolinske SC, Kulig KW, et al. Ibuprofen overdose–a prospective study. West J Med. 1988;148(6):653–656. Epub 1988/06/01.
   PubMedGoogle Scholar
• McElwee NE, Veltri JC, Bradford DC, et al. A prospective, population-based study of acute ibuprofen overdose: complications are rare and routine serum levels not warranted. Ann Emerg Med. 1990;19(6):657–662.
   PubMed Web of Science ®Google Scholar
• Al-Abri SA, Anderson IB, Pedram F, et al. Massive naproxen overdose with serial serum levels. J Med Toxicol. 2015;11(1):102–105. Epub 2014/04/24.
   PubMedGoogle Scholar
• Bortone E, Bettoni L, Buzio S, et al. Triphasic waves associated with acute naproxen overdose: a case report. Clin Electroencephalogr. 1998;29(3):142–145. Epub 1998/07/11.
   PubMedGoogle Scholar
• Martinez R, Smith DW, Frankel LR. Severe metabolic acidosis after acute naproxen sodium ingestion. Ann Emerg Med. 1989;18(10): 1102–1104. Epub 1989/10/01.
   PubMed Web of Science ®Google Scholar
• Waugh PK, Keatinge DW. Hypoprothrombinemia in naproxen overdose. Drug Intell Clin Pharm. 1983;17(7–8): 549–550. Epub 1983/07/01.
   PubMedGoogle Scholar
• Aygencel G, Akbuga B, Keles A. Acute pancreatitis following naproxen intake. Eur J Emerg Med. 2006;13(6): 372. Epub 2006/11/09.
   PubMed Web of Science ®Google Scholar
• Kulling PE, Backman EA, Skagius AS, et al. Renal impairment after acute diclofenac, naproxen, and sulindac overdoses. J Toxicol Clin Toxicol. 1995;33(2):173–177. Epub 1995/01/01.
   PubMed Web of Science ®Google Scholar
• Al Riyami N, Zimmerman AC, Rosenberg FM, et al. Spurious hyperbilirubinemia caused by naproxen. Clin Biochem. 2009;42(1–2):129–131. Epub 2008/11/04.
   PubMed Web of Science ®Google Scholar
• Lee WM. Acute liver failure. Semin Respir Crit Care Med. 2012;33(1): 36–45. Epub 2012/03/27.
   PubMed Web of Science ®Google Scholar
• Jaeschke H. Acetaminophen: dose-dependent drug hepatotoxicity and acute liver failure in patients. Dig Dis. 2015;33(4): 464–471. Epub 2015/07/15.
   PubMed Web of Science ®Google Scholar
• Gulmez SE, Larrey D, Pageaux GP, et al. Liver transplant associated with paracetamol overdose: results from the seven-country SALT study. Br J Clin Pharmacol. 2015;80(3):599–606. Epub 2015/05/29.
   PubMed Web of Science ®Google Scholar
• Doyon S, Klein-Schwartz W, Lee S, et al. Fatalities involving acetaminophen combination products reported to United States poison centers. Clin Toxicol (Phila). 2013;51(10):941–948.
   PubMed Web of Science ®Google Scholar
• Cooper SA, Needle SE, Kruger GO. Comparative analgesic potency of aspirin and ibuprofen. J Oral Surg. 1977;35(11):898–903.
   PubMedGoogle Scholar
• Schou S, Nielsen H, Nattestad A, et al. Analgesic dose-response relationship of ibuprofen 50, 100, 200, and 400 mg after surgical removal of third molars: a single-dose, randomized, placebo-controlled, and double-blind study of 304 patients. J Clin Pharmacol. 1998;38(5):447–454.
   PubMed Web of Science ®Google Scholar
• Walker AM. Quantitative studies of the risk of serious hepatic injury in persons using nonsteroidal antiinflammatory drugs. Arthritis Rheum. 1997;40(2): 201–208. Epub 1997/02/01.
   PubMed Web of Science ®Google Scholar