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- Title
Incidence of Stevens-Johnson syndrome/toxic epidermal necrolysis among new users of different individual drugs in a European population: a case-population study.
- Authors
Rodríguez-Martín, Sara; Rodríguez-Miguel, Antonio; de Abajo, Francisco J.; Lerma, Victoria; Martín-Merino, Elisa; González, Olga; González-Herrada, Carlos; Ramírez, Elena; Bellón, Teresa
- 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.
- Subjects
EUROPE; 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
- Publication
European Journal of Clinical Pharmacology, 2019, Vol 75, Issue 2, p237
- ISSN
0031-6970
- Publication type
Article
- DOI
10.1007/s00228-018-2569-3