Sara Rodríguez-Martín1,2,3, Elisa Martín-Merino4, Victoria Lerma1,3, Antonio Rodríguez-Miguel1,2,3, Olga González5, Carlos González-Herrada5, Elena Ramírez6, Teresa Bellón7, Francisco J de Abajo8,9,10. 1. Clinical Pharmacology Unit, Príncipe de Asturias University Hospital, Alcalá de Henares, Madrid, Spain. 2. Department of Biomedical Sciences, University of Alcalá, Ctra. Alcalá-Meco s/n, 28805, Alcalá de Henares, Madrid, Spain. 3. Pharmacoepidemiology Research Group, Institute for Health Research IRYCIS, Madrid, Spain. 4. Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency of Medicines and Medical Devices, Madrid, Spain. 5. Dermatology Department, University Hospital of Getafe, Getafe, Madrid, Spain. 6. Clinical Pharmacology Department, La Paz University Hospital, Madrid, Spain. 7. Drug Hypersensitivity Laboratory, Institute for Health Research IdiPAZ, La Paz University Hospital, Madrid, Spain. 8. Clinical Pharmacology Unit, Príncipe de Asturias University Hospital, Alcalá de Henares, Madrid, Spain. francisco.abajo@uah.es. 9. Department of Biomedical Sciences, University of Alcalá, Ctra. Alcalá-Meco s/n, 28805, Alcalá de Henares, Madrid, Spain. francisco.abajo@uah.es. 10. Pharmacoepidemiology Research Group, Institute for Health Research IRYCIS, Madrid, Spain. francisco.abajo@uah.es.
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.
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.
Authors: Sara Rodríguez-Martín; Francisco J de Abajo; Miguel Gil; Diana González-Bermejo; Antonio Rodríguez-Miguel; Diana Barreira-Hernández; Ramón Mazzucchelli; Alberto García-Lledó; Luis A García-Rodríguez Journal: J Clin Med Date: 2019-12-05 Impact factor: 4.241
Authors: Bretislav Lipovy; Jakub Holoubek; Marketa Hanslianova; Michaela Cvanova; Leo Klein; Ivana Grossova; Robert Zajicek; Peter Bukovcan; Jan Koller; Matus Baran; Peter Lengyel; Lukas Eimer; Marie Jandova; Milan Kostal; Pavel Brychta; Petra Borilova Linhartova Journal: Microorganisms Date: 2021-01-19
Authors: P O'Reilly; C Kennedy; P Meskell; A Coffey; I Delaunois; L Dore; S Howard; B Ramsay; C Scanlon; D M Wilson; B Whelan; S Ryan Journal: Br J Dermatol Date: 2020-01-11 Impact factor: 9.302