Side effects of 5-aminosalicylic acid;Effets indesirables de l'acide 5-aminosalicylique

Gastroenterologie Clinique et Biologique

Volumn 21, Issue 5, 1997, Pages 377-386

  Marteau, Philippe ^a,b,c   Cellier, Christophe ^a  

^a Hopital Laennec   (France)

^b Hopital Saint Lazare   (France)

^c Ferring Pharmaceuticals   (France)

Author keywords

5 aminosalicylic acid; mesalazine; olsalazine; side effects; treatment of inflammatory bowel disease

Indexed keywords

AMINOSALICYLIC ACID; MESALAZINE; OLSALAZINE; SALAZOSULFAPYRIDINE; AMINOSALICYLIC ACID DERIVATIVE; NONSTEROID ANTIINFLAMMATORY AGENT;

BLOOD CLOTTING DISORDER; CYTOPENIA; DIARRHEA; DRUG HYPERSENSITIVITY; ENTERITIS; EOSINOPHILIA; FERTILITY; HUMAN; MYOCARDITIS; PERICARDITIS; REVIEW; FEMALE; MALE; PREGNANCY;

AMINOSALICYLIC ACIDS; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; FEMALE; HUMANS; INFLAMMATORY BOWEL DISEASES; MALE; MESALAMINE; PREGNANCY;

EID: 0030633995     PISSN: 03998320     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (118)

1. Azad Khan AK, Piris J, Truelove SC. An experiment to determine the active therapeutic moiety of sulphasalazine. Lancet 1977;1:892-5.
2. Modigliani R, Rambaud JC. Les nouveaux dérivés de la salazosulfapyridine. Un progrès dans le traitement des maladies inflammatoires chroniques de l'intestin. Gastroenterol Clin Biol 1987;11:325-32.
3. Layer P, Goebell H. Pharmacology of aminosalicylates: luminal and systemic availability. Sixty-seventh Falk Symposium, Regensburg, Germany, 1992;335-42.
4. Hanauer SB, Stathopoulos G. Risk-benefit assessment of drugs used in the treatment of inflammatory bowel disease. Drug Safety 1991;6:192-219.
5. Wadworth AN, Fitton A. Olsalazine: a review of its pharmacodynamic and pharmacokinetie properties, and therapeutic potential in inflammatory bowel disease. Drugs 1991;41:647-64.
6. Layer PH, Goebell H, Keller J, Dignass A, Klotz U. Delivery and fate of oral mesalamine microgranules within the human small intestine. Gastroenterology 1995;108:1427-33.
7. Staerk Laursen L, Stockholm M, Bukhave K, Rask-Madsen J, Lauritsen K. Disposition of 5-aminosalicylic acid by olsalazine and three mesalazine preparations in patients with ulcerative colitis: comparison of intraluminal colonie concentrations, serum values, and urinary excretion. Gut 1990;31:1271-6.
8. Christensen LA, Fallinborg J, Jacobsen BA, Abildgaard K, Rasmussen HH, Hansen SH et al. Comparative bioavailability of 5-aminosalicylic acid from controlled release preparation and an azo-bond preparation. Aliment Pharmacol Ther 1994;8:289-94.
9. Taffet SL, Das KM. Sulfasalazine. Adverse effects and desensitization. Dig Dis Sci 1983;28:833-42.
10. Hanauer S. Drug therapy: Inflammatory bowel disease. N Engl J Med 1996;334:841-7
11. Segars LW, Gales BJ. Mesalamine and olsalazine: 5-aminosalicylic acid agents for the treatment of inflammatory bowel disease. Clin Pharm 1992;11:514-28.
12. Meyers S, Sachard DB, Present DH, Janowitz HD. Olsalazine in the treatment of ulcerative colitis among patients intolerant of sulphasalazine: a prospective, randomized, placebo-controlled, double-blind, dose-ranging clinical trial. Scand J Gastroenterol 1988;23:29-37.
13. Lauritsen K, Staerk Laursen L, Bukhave K, Rask-Madsen J. Longterm olsalazine treatment: pharmacokinetics, tolerance and effects on local eicosanoid formation in ulcerative colitis and Crohn's colitis. Gut 1988;29:974-82.
14. Järnerot G. Clinical tolerance to olsalazine. Scand J Gastroenterol 1988;23 (suppl 148):21-3.
15. Järnerot G. Withdrawal rates because of diarrhea in Dipentumtreated patients with ulcerative colitis are low when Dipentum is taken with food and dose-titrated. Gastroenterology 1996;110:A932.
16. Marteau P, Nelet F, Le Lu M, Devaux C. Adverse events in patients treated with 5-aminosalicylic acid: 1993-1994 pharmacovigilance report for Pentasa in France. Aliment Pharmacol Ther 1996;10:949-56.
17. Rao SS, Cann PA, Holdsworth CD. Clinical experience of the tolerance of mesalazine and olsalazine in patients intolerant of suphasalazine. Scand J Gastroenterol 1987;22:332-6.
18. Turunen U, Elomaa I, Anttila VJ, Seppala K. Mesalazine tolerance in patients with inflammatory bowel disease and previous intolerance or allergy to sulphasalazine or sulphonamides. Scand J Gastroenterol 1987;22:798-802.
19. Tolia V, Massoud N, Klotz U. Oral 5-aminosalicylic acid in children with colonie chronic inflammatory bowel disease: clinical and pharmacokinetic experience. J Pediatr Gastroenterol Nutr 1989;8:333-8.
20. Giaffer MH, O'Brien CJ, Holdsworth CD. Clinical tolerance to three 5-aminosalicylic acid releasing preparations in patients with inflammatory bowel disease intolerant or allergic to sulphasalazine. Aliment Pharmacol Ther 1992;6:51-9.
21. Schoojans R, Mast A, Van Den Abeele G, Dewilde D, Achten E, Van Maele V, et al. Sulfasalazine-associated encephalopathy in a patient with Crohn's disease. Am J Gastroenterol 1993;88:1759-63.
22. Dwarakanath AD, Michael J, Allan RN. Sulfasalazine-induced renal failure. Gut 1992;33:1006-7.
23. Chester AC, Diamond LH, Schreiner GE. Hypersensitivity to salicylazosulfapyridine. Renal and hepatic toxic reactions. Arch Intern Med 1978;138:1138-9.
24. Barbour VM, Williams PF. Nephrotic syndrome associated with sulfasalazine. Br Med J 1990;301:818.
25. Hautekeete ML, Bourgeois N, Potvin P, Duville L, Reynaert H. Devis G et al. Hypersensitivity with hepatotoxicity to mesalazine after hypersensitivity to sulfasalazine. Gastroenterology 1992;103:1925-7.
26. Lesur G, Saveuse H, Legros V, Rouveix E, Brion V, Parlier H et al. Eruption cutanée et pneumopothie d'hypersensibilité au cours d'un traitement par le 5-aminosalicylate. Gastroenterol Clin Biol 1991;15:457.
27. Lim AG, Hine KR. Fever, vasculitis rash, arthritis, pericarditis, and pericardial effusion after mesalazine. Br Med J 1994;308:113.
28. Finnie IA, Gilmore IT, Skin rash, fever and rigors caused by olsalazine. Eur J Gastroenterol Hepatol 1993;5:881-3.
29. Stevenson DD. Aspirin and nonsteroidal anti-inflammatory drugs. Immunol Allerg Clinics North Am 1995;15:529-52.
30. Greenfield SM, Punchard NA, Teare JP, Thompson RPH. Review article: the mode of action of the aminosalicylates in inflammatory bowel disease. Aliment Pharmacol Ther 1993;7:369-83.
31. Alstead EM, Wilson AGMCT, Farthing MJG. Lichen planus and mesalazine. J Clin Gastroenterol 1991;13:335-7.
32. Lizasoain J, Rubio FA, Erdozain JC, Olveira A, Conde P. Folliculitis and mesalamine. Am J Gastroenterol 1996;91:819-20.
33. Dent M, Ganapathy S, Holdsworth C, Channer K. Mesalazine induced lupus-like syndrome. Br Med J 1992;305:159.
34. Kutty PK, Raman KRK, Hawken K, Barrowman JA. Hair loss and 5-aminosalicylic acid enemas. Ann Intern Med 1982;97:785-6.
35. Hadjigogos K. Unusual side effects of mesalazine. Ital J Gastroenterol 1991;23:257.
36. Treem W, Veligati L, Rotter J, Targan S, Hyams J. Ulcerative colitis and total alopecia in a mother and her son. Gastroenterology 1993;104:1187-91.
37. Liau ME, Viraben R, Montastruc JL. Les alopécies médicamenteuses: revue de la littérature. Therapie 1995;50:145-50.
38. Honeybourne D. Mesalazine toxicity. Br Med J 1994;308:533-4.
39. Waanders H, Thompson J. Kawasaki-like syndrome after treatment with mesalazine. Am J Gastroenterol 1991;86:219-21.
40. Jick H, Myers MW, Dean AD. The risk of sulfasalazine- and mesalazine-associated blood disorders. Pharmacotherapy 1995;15:176-81.
41. Bodin F, Biour M, Grange JD. Leucopénie au décours de la prise de sulfasalazine puis de mésalazine chez un même patient. Therapie 1991;46:341.
42. Wyatt S, Joyner MV, Daneshmend TK. Filgrastim for mesalazine-associated neutropenia. Lancet 1993;341:1476.
43. Daneshmend TK. Mesalazine-associated thrombocytopenia. Lancet 1991;337:1297-8.
44. Abboudi ZH, Warsh JCW, Smith-Laing G, Gordon-Smith EC. Fatal aplastic anaemia after mesalazine. Lancet 1994;343:542.
45. Winther K, Bondesen S, Honore Hansen S, Hvidberg EF. Lack of effects of 5-aminosalicylic acid on platelet aggregation and fibrinolytic activity in vivo and in vitro. Eur J Clin Pharmacol 1987;33:419-22.
46. Raimundo A, Patil D, Frost P, Silk D. Effects of olsalazine and sulphasalazine on jejunal and ileal water and electrolyte absorption in normal human subjects. Gut 1991;32:270-4.
47. 2 in subjects with permanent ileostomy. Gut 1986;27:1306-11.
48. Pamukcu R, Hanauer SB, Chang EG. Effect of disodium azodisalicylate on electrolyte transport in rabbit ileum and colon in vitro. Gastroenterology 1988;95:975-81.
49. Chakraborty TK, Bhatia D, Heading RC, Ford MJ. Salicylate induced exacerbation of ulcerative colitis. Gut 1987;28:613-5.
50. Austin CA, Cann PA, Jones TH, Holdsworth CD. Exacerbation of diarrhoea and pain in patients treated with 5-aminosalicylic acid for ulcerative colitis. Lancet 1984;1:917-8.
51. Nelis GF. Diarrhoea due to 5-aminosalicylic acid in breast milk. Lancet 1989;1:383-4.
52. Schwartz AG, Targan SR, Axon A, Weinstein WM. Sulphasalazine-induced exacerbation of ulcerative colitis. N Engl J Med 1982;306:409-12.
53. Shanahan F, Targan S. Sulfasalazine and salieylate-induced exacerbation of ulcerative colitis. N Engl J Med 1987;317:455.
54. Sturgeon JB, Bhatia P, Hermens D, Miner PB, Exacerbation of chronic ulcerative colitis with mesalamine. Gastroenterology 1995;108:1889-93.
55. Kapur KC, Williams GT, Allison MC. Mesalazine induced exacerbation of ulcerative colitis. Gut 1995;37:838-9.
56. Besseau M, Delchier JC, Blazquez M, Soule JC. Pancréatite aiguë due à la mésalazine (Pentasa®). Gastroenterol Clin Biol 1991;15:174.
57. Poldermans D, Van Blankenstein M. Pancreatitis induced by disodium azodisalicylate. Am J Gastroenterol 1988;83:578-80.
58. Sachedina B, Saibil F, Cohen LB, Whittey J. Acute pancreatitis due to 5-aminosalicylate. Ann Intern Med 1989;6:490-1.
59. Hochain P, Guedon C, Colin R. Pancréatite aiguë au cours d'une maladie de Crohn traitée par mésalazine orale. Gastroenterol Clin Biol 1991;15:173.
60. Deprez P, Descamps CH, Fiasse R. Pancreatitis induced by 5-aminosalicylic acid. Lancet 1989;2:445-6.
61. Fiorentini MT, Fracchia M, Galatola G, Barlotta A, de La Pierre M. Acute pancreatitis during oral 5-aminosalicylic acid therapy. Dig Dis Sci 1990;35:1180-2.
62. Tromm A, Huppe D, Micklefield GH, Sehwegler U, May B. Acute pancreatitis complicating Crohn's disease: mere coincidence or causality ? Gut 1992;33:1289-91.
63. Lankisch PG, Dröge M, Gottesleben F. Drug induced acute pancreatitis: incidence and severity. Gut 1995;37:565-7.
64. Isaacs KL, Murphy D. Pancreatitis after rectal administration of 5-aminosalicylic acid. J Clin Gastroenterol 1990;2:198-9.
65. Wilmink T, Frick TW. Drug-induced pancreatitis. Drug Safety 1996;14:406-23.
66. Biour M, Poupon R, Grangé JD, Chazouillères O, Levy VG, Bodin F, et al. Hépatotoxicité des médicaments: 9ème mise à jour du fichier bibliographique des atteintes hépatiques et des médicaments responsables. Gastroenterol Clin Biol 1996;20:744-79.
67. Pineda JR, Leal JC, De La Morena E, Abreu L. Hepatotoxicidad: un efecto secundario nuevo del acido 5-aminosalicylico. Med Clin (Bare) 1989;93:516.
68. Rachmilewitz D. Coated mesalazine (5-aminosalicylic acid) versus sulphasalazine in the treatment of active ulcerative colitis: a randomised trial. Br Med J 1989;298:82-6.
69. Marteau P, Halphen M. Etude comparative randomisée de l'efficacité et de la tolérance de lavements de 2 g d'acide 4-amino-salicylique (4-ASA) et de 1 g d'acide 5-aminosalicylique (5-ASA) dans les formes basses de rectocolite hémorragique. Gastroenterol Clin Biol 1995;19:31-5.
70. Caldcr IC, Funder CC, Green CR, Hamm KN, Tange JD. Nephrotoxic lesions from 5-aminosalicylic acid. Br Med J 1972;1:152-4.
71. Thuro HC, Peters T, Andus T. Renal involvement in chronic inflammatory bowel diseases. Treatment-related side-effect or extraintestinal manifestation ? Falk Symposium, Regensburg, Germany, 1995:5-32.
72. Riley SA, Lloyd DR, Mani V. Tests of renal function in patients with quiescent colitis: effects of drug treatment. Gut 1992;33:1348-52.
73. Bonnet J, Lemann M, Prunat A, Eugene M, Chopin N, Modigliani R. Renal function in patients with inflammatory bowel disease (IBD) on long-term mesalazine (Mz) or olsalazine (Oz) (abstract). Gastroenterology 1995;108:A786.
74. Kreisel W, Wolf LM, Grotz W, Grieshaber M. Renal tubular damage: an extraintestinal manifestation of chronic inflammatory bowel disease. Eur J Gastroenterol Hepatol 1996;8:461-8.
75. Smilde TJ, Van Liebergen FJHM, Koolen MI, Gerlag PGG, Assmann KJM, Berden JHM. Tubulo-interstitiële nefritis door mesalazine (5-ASA)-preparaten. Ned Tijdschr Geneeskd 1994;138:2557-61.
76. Wilcox GM, Reynolds JR, Galvanek EG. Nephrotoxicity associated with olsalazine. Am J Med 1996;100:238-40.
77. Ruf-Ballauf W, Hofstadter F, Krentz K. Akute interstitielle Nephritis durch 5-aminosalicylsäure ? Internist 1989;30:262-4.
78. Henning HV, Meinhold J, Eisenhauer JH, Scheler F. Chronische interstitielle Nephritis nach Behandlung mit 5-aminosalicylsäure. Dtsch Med Wochenschr 1989;114:1091.
79. Von Mühlendahl KE. Nephritis durch 5-aminosalicylsaüre, Dtsch Med Wochenschr 1989;114:236.
80. Mehta RP. Acute interstitial nephritis due to 5-aminosalicylic acid. Can Med Assoc J 1990;143:1031-2.
81. Tremainc WJ, Schroeder KW. Urinary sediment abnormalities in patients on long term oral aminosalicylic acid (5-ASA) for chronic ulcerative colitis (CUC) (abstract). Gastroenterology 1988;94:A465.
82. Committee on Safety of Medicines. Nephrotoxicity associated with mesalazine (Asacol®). Current Problems 1990;30:2.
83. Schroeder KW, Tremaine WJ. Oral 5-aminosalicylic acid (Asacol) for treatment of symptomatic chronic ulcerative colitis (Abstract). Gastroenterology 1986;90:A58.
84. Novis BH, Korzets Z, Cohen P, Bernheim J. Nephrotic syndrome after treatment with 5-aminosalicylic acid. Br Med J 1988;296:1442.
85. Masson EA, Rhodes JM. Mesalazine-associated nephrogenic diabetes insipidus presenting as weight loss. Gut 1992;33:563-4.
86. Tuluvulath PJ, Ninkovic M, Calam J, Anderson M. Mesalazine-induced interstitial nephritis. Gut 1994;35:1493-6.
87. World MJ, Stevens PE, Ashton MA, Rainford DJ. Mesalazine-associated interstitial nephritis. Nephrol Dial Transplant 1996;11:614-21.
88. Witte T, Olbricht CJ, Koch KM. Interstitial nephritis associated with 5-aminosalicylic acid. Nephron 1994;67:481-2.
89. Mahmud N, McDonald GSA, Kelleher D, Weir DG. Microalbuminuria correlates with intestinal histopathological grading in patients with inflammatory bowel disease. Gut 1996;38:99-103.
90. Camus P, Piard F, Ashcroft T, Gal AA, Colby TV. The lung in inflammatory bowel disease. Medicine 1993;72:151-83.
91. FDA. Rare adverse reaction with rowasa. FDA Drug Bull 1989;19:17-8.
92. Heresbach D, Rabot A, Génetet N, Marteau P, Stéphan C, Bretagne JF et al. Péricardite au cours des maladies inflammatoires intestinales. Complication extraintestinale ou iatrogène ? Gastroenterol Clin Biol 1994;18:782-5.
93. Desmeules J, Vogt N, Loizeau S. Angelillo-Scherrer A, Dayer P. Péricardite récidivante induite par la mésalazine (5-ASA). Thérapie 1994;49:359-61
94. Agnholt J, Sorensen HT, Rasmussen SN, Gotzsche CO, Halkier P. Cardiac hypersensitivity to 5-aminosalicylic acid. Lancet 1989;2:1135.
95. Kristensen KS, Hoegholm A, Bohr L, Friis S. Fatal myocarditis associated with mesalazine. Lancet 1992;335:605.
96. Frid C, Bjarke B, Eriksson M. Myocarditis in children with inflammatory bowel disease. J Clin Pediatr Gastroenterol Nutr 1986;5:964-5.
97. Welte T, Hamm H, Fabel H. Mesalazine alveolitis. Lancet 1991;338:1273.
98. Reinoso MA, Schroeder KW, Pisani RJ. Lung disease associated with orally administered mesalazine for ulcerative colitis. Chest 1992;101:1469-71.
99. Bitton A, Peppercorn MA, Hanrahan JP, Upton MP, Mesalamine-induced lung toxicity. Am J Gastroenterol 1996;91:1039-40.
100. Woodward DK. Peripheral neuropathy and mesalazine. Br Med J 1989;299:1224.
101. Birnie GG, McLeod TIF, Watkinson G. Incidence of sulphasalazine-induced male infertility. Gut 1981;22:452-5.
102. Zelissen PMJ, Van Hattum J, Poen H, Scholten P, Gerritse R, Velde TE. Influence of salazosullphapyridine and 5-aminosalicylic acid on seminal qualities and male sex hormones. Scand J Gastroenterol 1988;22:1100-4.
103. Chatzinoff M, Guarino JM, Corson SL, Batzer FR, Friedman LS. Sulfasalazine-induced abnormal sperm penetration assay reversed on changing to 5-aminosalicylic acid enemas. Dig Dis Sci 1988;33:108-10.
104. Järnerot G, Into-Malmberg MB, Esbjörner E. Placental transfer of sulphasalazine and sulphapyridine and some of its metabolites. Scand J Gastroenterol 1981;16:693-7.
105. Christensen LA, Rasmussen SN, Honore Hansen S, Bondesen S, Hvidberg EF. Salazosulfapyridine and metabolites in fetal and maternal body fluids with special reference to 5-aminosalicylic acid. Acta Obstet Gynecol Scand 1987;66:433-5.
106. Willoughby CP, Truelove SC. Ulcerative colitis and pregnancy. Gut 1980;21:469-74.
107. Mogadam M, Dobbins WO, Korelitz BI, Ahined SW. Pregnancy in inflammatory bowel disease: effect of sulfasalazine and corticosteroids on fetal outcome. Gastroenterology 1981;80:72-6.
108. Khosla R, Willoughby CP, Jewell DP. Crohn's disease and pregnancy. Gut 1984;25:52-6.
109. Colombel JF, Brabant G, Gubler MC, Locquet A, Comes MC, Dehennault M, et al. Renal insufficiency in infant: side-effect of prenatal exposure to mesalazine ? Lancet 1994;344:620-1.
110. Marteau P, Devaux C. Mesalazine during pregnancy. Lancet 1994;344:1708-9
111. Habal FM, Hui G, Greenberg GR. Oral 5-aminosalicylic acid for inflammatory bowel disease in pregnancy: safety and clinical course. Gastroenterology 1993;105:1057-60.
112. Trallori G, D'Albasio G, Bardazzi G, Bonanomi AG, Amorosi A, Del Carlo P, et al. 5-aminosalicylic acid in pregnancy: clinical report. Ital J Gastroenterol 1994;26:75-8.
113. Jonville Bera AP, Soyez C, Fignon A, Moraine C, Berger C, Autret E. Pentasa® (mésalazine) et grossesse. Therapie 1994;49:443-5.
114. Marteau P, Crand J, Devaux C. Mesalazine in pregnancy: fetal outcome in 76 IBD patients treated with Pentasa® (abstract). Gastroenterology 1995;108:A871.
115. Tennenbaum R, Cosnes J, Eléfant E, Marteau P, Rambaud JC, Modigliani R, et al. Pronostic fœtal au cours des maladies inflammatoires intestinales (MICI) (résumé). Gastroenterol Clin Biol 1997;21:A175.
116. Jenss H, Weber P, Hartmann F. 5-aminosalicylic acid and its metabolite in breast milk during lactation. Am J Gastroenterol 1990;85:331.
117. Ito S, Blajchman A, Stephenson M, Eliopoulos C, Koren GK. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol 1993;168:1393-9.
118. Szumlanski CL, Weinshilbourn RM. Sulphalsalazine inhibition of thiopurine methyltransferase: possible mechanism for interaction with 6-mercaptopurine and azathioprine. Br J Clin Pharmacol 1995;39:456-9.