1. Incidence of Stevens-Johnson syndrome/toxic epidermal necrolysis among new users of different individual drugs in a European population: a case-population study.
- Author
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Rodríguez-Martín, Sara, Rodríguez-Miguel, Antonio, de Abajo, Francisco J., Lerma, Victoria, Martín-Merino, Elisa, González, Olga, González-Herrada, Carlos, Ramírez, Elena, and Bellón, Teresa
- Subjects
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ACETAMINOPHEN , *AMOXICILLIN , *CAUSALITY (Physics) , *CENSUS , *CLAVULANIC acid , *CONFIDENCE intervals , *REPORTING of diseases , *LORAZEPAM , *NONSTEROIDAL anti-inflammatory agents , *OMEPRAZOLE , *PHENYTOIN , *QUINOLONE antibacterial agents , *SULFAMETHOXAZOLE , *TOXIC epidermal necrolysis , *IBUPROFEN , *PROTON pump inhibitors , *DISEASE incidence , *DEXAMETHASONE , *STEVENS-Johnson Syndrome , *ALLOPURINOL - Abstract
Purpose: To estimate the specific incidences of Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) among new users of drugs frequently reported to be associated with this serious event.Methods: We performed a case-population approach, which combined data from a registry of SJS/TEN cases from the Madrid region (numerator) during the study period 2005-2015 and a primary healthcare database from the same catchment population. The proportion of new users of drugs estimated in the primary healthcare database was stratified by calendar year, sex and age (5-year bands), and then applied to the same strata of Madrid's population census to compute the number of new users (denominator). Incidences were re-estimated using only cases in which the concerned drug had a probable or very probable causal relationship.Results: A total of 44 SJS/TEN cases aged > 14 years were registered during the study period. The highest SJS/TEN incidence was found for phenytoin with 68.9 per 100,000 new users (95% CI 27.7-141.9), followed by dexamethasone (5.48; 1.49-14.03), allopurinol (3.29; 1.07-7.67) and cotrimoxazole (3.19; 0.87-8.16). Considering only probable and very probable cases, the incidences hardly changed, except for dexamethasone, which was left without cases. Pantoprazole, levofloxacin and lorazepam showed incidences between 1 per 100,000 and 1 per 1,000,000 new users. Ibuprofen, amoxicillin-clavulanic acid, metamizole, amoxicillin, paracetamol and omeprazole showed incidences around 1 per one million new users.Conclusions: Phenytoin was the drug with the highest incidence of SJS/TEN, followed by allopurinol and cotrimoxazole. For the rest of the drugs, the estimated incidences were below 1 in 100,000 new users. [ABSTRACT FROM AUTHOR]
- Published
- 2019
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