Display options
Cite
Stürchler D, Mittelholzer ML, Kerr L. How frequent are notified severe cutaneous adverse reactions to Fansidar?. Drug Saf. 1993;8(2):160-8doi: 10.2165/00002018-199308020-00006.
Stürchler, D., Mittelholzer, M. L., & Kerr, L. (1993). How frequent are notified severe cutaneous adverse reactions to Fansidar?. Drug safety, 8(2), 160-8. https://doi.org/10.2165/00002018-199308020-00006
Stürchler, D, et al. "How frequent are notified severe cutaneous adverse reactions to Fansidar?." Drug safety vol. 8,2 (1993): 160-8. doi: https://doi.org/10.2165/00002018-199308020-00006
Stürchler D, Mittelholzer ML, Kerr L. How frequent are notified severe cutaneous adverse reactions to Fansidar?. Drug Saf. 1993 Feb;8(2):160-8. doi: 10.2165/00002018-199308020-00006. PMID: 8452657.
Copy Download .nbib Format: NLM
Share it on
Full text links
Springer

Drug Saf. 1993 Feb;8(2):160-8. doi: 10.2165/00002018-199308020-00006.

How frequent are notified severe cutaneous adverse reactions to Fansidar?.

Drug safety

D Stürchler, M L Mittelholzer, L Kerr

Affiliations

  1. Clinical Research and Drug Safety Departments, F. Hoffmann-La Roche Ltd., Basel, Switzerland.

PMID: 8452657 DOI: 10.2165/00002018-199308020-00006

Abstract

An attempt was made to estimate the risk of severe cutaneous adverse reactions (SCARs) to Fansidar (sulfadoxine plus pyrimethamine). Cases were identified through a spontaneous reporting system. Persons exposed were estimated using sales data of 27 countries reporting one SCAR case for either Fansidar or a related product, Bactrim (cotrimoxazole; sulfamethoxazole plus trimethoprim). Between 1974 and 1989, 126 cases were notified for Fansidar: 87 cases of erythema multiforme or Stevens-Johnson syndrome, and 39 cases of toxic epidermic necrolysis. 86% of cases were reported in Europe or North America. In 116 cases with use known, prophylaxis was the reason in 103, and treatment in 13. Toxic epidermolysis and erythema multiforme/Stevens-Johnson syndrome had case fatalities of 36 (95% confidence intervals 21 to 53%) and 9% (4 to 18%), respectively. Fansidar users were estimated at 117 million, and the overall SCAR risk to be 1.1 (0.9 to 1.3) per million. For developing countries with mainly single dose use, the risk was estimated to 0.1 (0.0 to 0.1) per million. For Europe and North America with mainly prophylactic use, the risk was 10 (8 to 12) and 36 (23 to 48) per million, respectively. Prophylactic use had a 40 times higher risk than single dose therapeutic use. The aggregated risk peaked in 1984-1985, with global and North American SCAR frequencies of 3.4 (2.4 to 4.3) and 72 (41 to 102) per million, respectively. After 1985, North America reported only one further case despite continued use by an estimated 0.3 million persons.(ABSTRACT TRUNCATED AT 250 WORDS)

Cited by

References

  1. BMJ. 1990 Feb 24;300(6723):499-503 - PubMed
  2. Bull World Health Organ. 1990;68(2):209-15 - PubMed
  3. Am J Trop Med Hyg. 1977 Nov;26(6 Pt 1):1108-15 - PubMed
  4. Sem Hop. 1983 Mar 10;59(10):671-5 - PubMed
  5. J Infect. 1986 Jul;13(1):31-3 - PubMed
  6. Acta Trop. 1988 Sep;45(3):217-24 - PubMed
  7. N Engl J Med. 1986 Jun 12;314(24):1589-92 - PubMed
  8. Acta Med Scand. 1975 Sep;198(3):229-33 - PubMed
  9. MMWR Morb Mortal Wkly Rep. 1988 May 6;37(17):277-84 - PubMed
  10. Lancet. 1985 Nov 9;2(8463):1072-3 - PubMed
  11. Lancet. 1986 Mar 15;1(8481):610 - PubMed
  12. Trans R Soc Trop Med Hyg. 1988;82(5):694 - PubMed
  13. Lancet. 1985 Dec 7;2(8467):1298-9 - PubMed
  14. Arch Dermatol. 1991 Jun;127(6):839-42 - PubMed
  15. Am J Dis Child. 1985 May;139(5):499-502 - PubMed
  16. Trans R Soc Trop Med Hyg. 1990 Sep-Oct;84(5):641-3 - PubMed
  17. Br Med J (Clin Res Ed). 1986 Mar 15;292(6522):746-50 - PubMed
  18. Arch Intern Med. 1990 Feb;150(2):271-9 - PubMed
  19. J R Soc Med. 1990 Feb;83(2):82-5 - PubMed
  20. J Am Acad Dermatol. 1985 Oct;13(4):623-35 - PubMed
  21. MMWR Morb Mortal Wkly Rep. 1985 Jan 4;33(51-52):713-4 - PubMed
  22. Arch Dermatol. 1991 Jun;127(6):831-8 - PubMed
  23. JAMA. 1975 Aug 18;233(7):812-3 - PubMed
  24. Arch Dermatol. 1990 Jan;126(1):43-7 - PubMed
  25. Ulster Med J. 1978;47(1):95-9 - PubMed
  26. Klin Wochenschr. 1990 Mar 5;68(5):277-80 - PubMed
  27. Arch Dermatol. 1990 Jan;126(1):37-42 - PubMed
  28. MMWR Morb Mortal Wkly Rep. 1982 Apr 16;31 Suppl 1:1S-28S - PubMed
  29. Ann Dermatol Syphiligr (Paris). 1968;95(5):481-90 - PubMed
  30. Bull World Health Organ. 1990;68(3):313-22 - PubMed
  31. Lancet. 1982 Dec 25;2(8313):1459 - PubMed
  32. Z Hautkr. 1987 Mar 1;62(5):369-70, 375-8 - PubMed
  33. Parasitol Today. 1991 Oct;7(10):277-81 - PubMed
  34. Br Med J (Clin Res Ed). 1988 Jun 4;296(6636):1605 - PubMed
  35. Dermatologica. 1990;180(3):124-9 - PubMed
  36. Ann Trop Med Parasitol. 1974 Sep;68(3):367-8 - PubMed
  37. Med J Malaysia. 1987 Mar;42(1):44-9 - PubMed
  38. Med Clin (Barc). 1983 May 21;80(18):799-801 - PubMed
  39. Med J Aust. 1987 Mar 16;146(6):335-6 - PubMed
  40. J R Soc Med. 1990 Sep;83(9):598-9 - PubMed
  41. Am J Trop Med Hyg. 1986 May;35(3):451-8 - PubMed
  42. Dermatologica. 1989;178(1):39-42 - PubMed
  43. J Am Acad Dermatol. 1984 Jun;10(6):973-8 - PubMed
  44. Br Med J (Clin Res Ed). 1987 Aug 8;295(6594):365-6 - PubMed

Substances

MeSH terms

Publication Types

LinkOut - more resources