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Revue d'Epidémiologie et de Santé Publique
Volume 57, n° S1
page 38 (mai 2009)
Doi : 10.1016/j.respe.2009.02.132

Medications as risk factors of Stevens-Johnson syndrome and toxic epidermal necrolysis in children: a pooled analysis

N. Levi a, S. Bastuji-Garin b, M. Mockenhaupt c, J.C. Roujeau d, A. Flahault e, J.P. Kelly f, D.W. Kaufman f, P. Maison a, g
a Service de pharmacologie clinique, France 
b Service de santé publique, France 
c Dermatology, University Medical Center, Freiburg, Germany 
d Service de dermatologie, France 
e École des hautes études en santé publique, Paris, Rennes, France 
f Slone Epidemiology Center, Boston University, Boston, USA 
g Unité de recherche clinique, hôpital Henri-Mondor, Créteil, France 

Keywords : Pooled analysis, Pharmacoepidemiology, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Lyell syndrome

Objective. – The aim of this study was to determine the relation of medications to the risk of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) in children under 15 years old.

Methods .– We conducted a pooled analysis using data from two multicenter international case-control studies: Severe Cutaneous Adverse Reaction (SCAR) and EuroSCAR conducted in France, Germany, Italy, Portugal, Netherlands, Austria and Israel. We selected cases aged less than 15 years old, hospitalized for SJS, SJS/TEN-overlap or TEN, and age, gender and country matched hospital controls. Pooled crude odds ratios (OR) were estimated using unconditional logistic regression and adjusted for confounding by multivariate methods where numbers permitted.

Results. – Our study included 80 cases and 216 matched controls. Among the 80 cases, 26% (N =21) were classified as having SJS, 34% (N =27) TEN and 40% (32) SJS/TEN-overlap. SJS/TEN cases were exposed to a mean value of 2.4 drugs, while controls were exposed to 0.75 drugs. Anti-infective sulfonamides (OR: 42; 95% CI lower limit: 6.6), phenobarbital (OR: 37; 95% CI lower limit: 5.4) carbamazepine (OR: 15; 95% CI lower limit: 1.8) and lamotrigine (OR: 15; 95% CI lower limit: 1.8) were strongly associated with the risk of SJS or TEN. Significant associations were highlighted in univariate analysis for valproic acid and NSAIDs as a group (OR: 28; 95% CI lower limit: 4.1, and OR: 11; 95% CI lower limit: 1.1 respectively) and for acetaminophen (paracetamol) in multivariate analysis (OR: 5.0; 95% CI: 1.9-13). The variation of the exposure window showed that the association could not only be explained by confounding by indication (protopathic bias).

Conclusion .– We confirmed four previously highly suspected drug risk factors for SJS/TEN in children: anti-infective sulfonamides, phenobarbital, carbamazepine and lamotrigine. Among more unexpected risk factors, we assume that acetaminophen (paracetamol) may substantially increase the risk of SJS/TEN in children.

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