Acetazolamide-induced pulmonary oedema: A disproportionality analysis from the EudraVigilance database.

Autor: García M; Biobizkaia Health Research Institute, Osakidetza Basque Health Service, Galdakao-Usansolo Hospital, Basque Country Pharmacovigilance Unit, Galdakao, Spain., Albizua Madariaga I; Osakidetza Basque Health Service, Pharmacy Service, Urduliz Hospital, Urduliz, Spain., Sainz-Gil M; Centro de Estudios sobre la Seguridad de los Medicamentos (CESME). Departamento de Biología Celular, Histología, Farmacología y Genética. Facultad de Medicina, Universidad de Valladolid, Valladolid, Spain.; Grupo de Investigación Reconocido 'Pharmacogenetics, Cancer Genetics, Genetic Polymorphisms and Pharmacoepidemiology', Universidad de Valladolid, Valladolid, Spain., Lertxundi U; Bioaraba Health Research Institute, Osakidetza Basque Health Service, Araba Mental Health Network, Araba Psychiatric Hospital, Pharmacy Service, Gasteiz, Alava, Spain.
Jazyk: angličtina
Zdroj: British journal of clinical pharmacology [Br J Clin Pharmacol] 2024 Jul; Vol. 90 (7), pp. 1751-1755. Date of Electronic Publication: 2024 May 21.
DOI: 10.1111/bcp.16117
Abstrakt: To our knowledge, no prior study has analysed a possible association between acetazolamide and pulmonary oedema. The aim of this study was to use data from the EudraVigilance to detect a safety signal for acetazolamide-induced pulmonary oedema. We performed a disproportionality analysis (case-noncase method), calculating reporting odds ratios (RORs) up to 22 February 2024. Among 11 684 208 spontaneous cases of adverse reactions registered in EudraVigilance, 38 275 were pulmonary oedemas. Acetazolamide was involved in 31 cases. In more than half of those cases, the patients received a single dose of acetazolamide after undergoing cataract surgery: latency was 10-90 min. Remarkably, there were five cases of positive rechallenge and six cases resulted in death. The ROR for acetazolamide was 3.63 (95% CI 2.55-5.17). Disproportionality was also observed in VigiBase®: ROR 4.44 (95% CI 3.34-5.90). Our study confirms a signal that suggests a risk of serious pulmonary oedema associated with acetazolamide.
(© 2024 British Pharmacological Society.)
Databáze: MEDLINE
Externí odkaz: