Suspected Adverse Drug Reactions From Corticosteroids: Analysis of Reported Notifications to the Portuguese Pharmacovigilance System. (2nd June 2020)

• Record Type: Journal Article
• Authors: Gonçalves, Cristel; Monteiro, Cristina; Santos, Jorge Luiz
• Is Part Of: Journal of clinical pharmacology. Volume 60:Number 10(2020)
• Page Start: 1367
• Page End: 1375
• Publication Date: 2020-06-02
• Subjects: corticosteroids -- adverse drug reactions -- pharmacovigilance -- pharmacoepidemiology; Pharmacology -- Periodicals; Pharmacology -- Periodicals; Pharmacology, Clinical -- Periodicals; 615.1
• DOI: 10.1002/jcph.1630
• Languages: English
• ISSNs: 0091-2700

Abstract

Abstract: We performed a retrospective, observational, and descriptive study on the reports of adverse reactions resulting from the use of corticosteroids, based on data from the Portuguese Pharmacovigilance System recorded between January 2009 and December 2018. A total of 569 reports with at least 1 suspected corticosteroid were included in the study, of which 59.1% belonged to individuals aged between 19 and 64 years. There was no significant predominance of sex, with 55% female patients. The notification trend has increased over the years, with the highest number of cases in 2018, 29.5%. Among the 3 groups of health professionals (nurses, pharmacists, and physicians), physicians were the ones who notified the majority. Regarding seriousness, 89.1% were classified as serious, and the most commonly reported corticosteroid as suspected drug was prednisolone, 65.6%. The system organ class group was reported in 37.8% of adverse reactions was infections and infestations. Despite the seriousness of most reports, 42.7% evolved to cure, even though 9.3% of the reports led to the death of patients. The assessment of causality by the regulatory authority was not performed in 84.4% of the reported cases. Although there were enhanced reporting rates of adverse reactions to corticosteroids, active search of their occurrence must be done. In light of the results obtained, educational programs about the importance of pharmacovigilance are essential.