Drug Safety

, Volume 36, Issue 8, pp 681–686

Stevens–Johnson Syndrome/Toxic Epidermal Necrolysis: Are Drug Dictionaries Correctly Informing Physicians Regarding the Risk?

  • Cynthia Haddad
  • Alexis Sidoroff
  • Sylvia H. Kardaun
  • Maja Mockenhaupt
  • Daniel Creamer
  • Ariane Dunant
  • Jean-Claude Roujeau
Original Research Article

DOI: 10.1007/s40264-013-0070-6

Cite this article as:
Haddad, C., Sidoroff, A., Kardaun, S.H. et al. Drug Saf (2013) 36: 681. doi:10.1007/s40264-013-0070-6



Stevens–Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) are severe drug reactions associated with high mortality and multiple incapacitating sequelae. In the past 20 years, two large multinational case control studies, published in 1995 and 2008, had identified different degrees of drug association with SJS/TEN: ‘strongly associated’, ‘associated’, ‘suspected’ and ‘not suspected’ medications.


The aim of this study was to check the adequacy of mention of risk of SJS/TEN in the drug dictionaries most widely used by physicians in five European countries.

Study Design

In each country one expert investigator looked at the most widely used drug dictionary (2009 edition) for mentions of risk of SJS/TEN. This was done for a predefined list of medications with a different degree of risk. The presence and clarity or absence of warning was compared with available evidence provided by published results from case–control studies.


The five countries participating in the RegiSCAR group: Austria, France, Germany, The Netherlands and the UK.


A total of 3,268 drug descriptions of medications for systemic use were analysed, including all brands of 14 ‘strongly associated’ drugs, 5 ‘associated’ drugs and 12 widely used drugs with no established association. Discrepancies were found by country, and between descriptions for different brands of the same generic. Among 522 descriptions of 14 ‘strongly associated’ drugs, only 5 did not mention the risk. For the 1,013 descriptions of ‘associated’ drugs, 3 % did not mention the risk. One-third of ‘not suspected’ drugs contained a specific or less specific warning (e.g. bullous cutaneous eruption). Warnings for ‘strongly associated’ medications were often as imprecise as those for ‘not suspected’ drugs.


Information on the risk of SJS/TEN in drug dictionaries needs improvement to enhance the quality of advice given by general physicians and to raise the understanding of risk by patients.

Supplementary material

40264_2013_70_MOESM1_ESM.pdf (50 kb)
Supplementary material 1 (PDF 49 kb)

Copyright information

© Springer International Publishing Switzerland 2013

Authors and Affiliations

  • Cynthia Haddad
    • 1
  • Alexis Sidoroff
    • 2
  • Sylvia H. Kardaun
    • 3
  • Maja Mockenhaupt
    • 4
  • Daniel Creamer
    • 5
  • Ariane Dunant
    • 6
  • Jean-Claude Roujeau
    • 1
    • 7
  1. 1.Henri Mondor HospitalUniversity Paris-Est CréteilCréteilFrance
  2. 2.Medical UniversityInnsbruckAustria
  3. 3.University Medical Center GroningenUniversity of GroningenGroningenThe Netherlands
  4. 4.Dokumentationszentrum schwerer Hautreaktionen (dZh)University Medical CenterFreiburgGermany
  5. 5.King’s College HospitalLondonUK
  6. 6.Biostatistics and Epidemiology UnitInstitut Gustave-RoussyVillejuifFrance
  7. 7.AntonyFrance

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