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Article

Risk of Hospitalization for Adverse Drug Events in Women and Men: A Post Hoc Analysis of an Active Pharmacovigilance Study in Italian Emergency Departments

1
Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, 50139 Florence, Italy
2
Tuscan Regional Center of Pharmacovigilance, 50122 Florence, Italy
3
Department of Experimental and Clinical Medicine, University of Florence, 50134 Florence, Italy
4
Internal Medicine, Medical Department, Vimercate Hospital, ASST di Vimercate, 20871 Vimercate, Italy
5
Joint Laboratory of Technological Solutions for Clinical Pharmacology, Pharmacovigilance and Bioinformatics, University of Florence, 50139 Florence, Italy
6
Pharmacology Unit, Department of Diagnostics and Public Health, University of Verona, 37100 Verona, Italy
*
Author to whom correspondence should be addressed.
These authors contributed equally to this manuscript.
Membership of the MEREAFaPS Study Group is provided in the Acknowledgments.
Academic Editor: Olivia Manfrini
Pharmaceuticals 2021, 14(7), 678; https://doi.org/10.3390/ph14070678
Received: 12 June 2021 / Revised: 9 July 2021 / Accepted: 13 July 2021 / Published: 15 July 2021
(This article belongs to the Special Issue Adverse Drug Reactions and Gender Differences)
This post hoc analysis of an Italian active pharmacovigilance study describes pharmacological differences of ADEs leading to emergency department (ED) visits and hospitalization in women and men. During the study period (January 2007–December 2018), 61,855 reports of ADEs leading to ED visits were collected. Overall, 30.6% of ADEs resulted in hospitalization (30% in women and 31% in men). Multivariate logistic regression showed that, among women, drug classes significantly associated with an increased risk of hospitalization were heparins (ROR 1.41, CI 1.13–176), antidepressants (ROR 1.12, CI 1.03–1.23) and antidiabetics (ROR 1.13, CI 1.02–1.24). Among men, only vitamin K antagonists (ROR 1.28, CI 1.09–1.50), opioids (ROR 1.30, CI 1.06–1.60) and digitalis glycosides (ROR 1.32, CI 1.09–1.59) were associated with a higher risk of hospitalization. Overall, older age, multiple suspected drugs and the presence of comorbidities were significantly associated with a higher risk of hospitalization. A significantly reduced risk of hospitalization was observed in both women and men experiencing an adverse event following immunization (ROR 0.36, CI 0.27–0.48 and 0.83, 0.42–0.74, respectively) compared to drugs. Results obtained from this real-world analysis highlight important aspects of drug safety between sexes. View Full-Text
Keywords: pharmacovigilance; clinical pharmacology; male; female; emergency department pharmacovigilance; clinical pharmacology; male; female; emergency department
MDPI and ACS Style

Crescioli, G.; Boscia, E.; Bettiol, A.; Pagani, S.; Spada, G.; Vighi, G.V.; Bonaiuti, R.; Venegoni, M.; Vighi, G.D.; Vannacci, A.; Lombardi, N.; on behalf of the MEREAFaPS Study Group. Risk of Hospitalization for Adverse Drug Events in Women and Men: A Post Hoc Analysis of an Active Pharmacovigilance Study in Italian Emergency Departments. Pharmaceuticals 2021, 14, 678. https://doi.org/10.3390/ph14070678

AMA Style

Crescioli G, Boscia E, Bettiol A, Pagani S, Spada G, Vighi GV, Bonaiuti R, Venegoni M, Vighi GD, Vannacci A, Lombardi N, on behalf of the MEREAFaPS Study Group. Risk of Hospitalization for Adverse Drug Events in Women and Men: A Post Hoc Analysis of an Active Pharmacovigilance Study in Italian Emergency Departments. Pharmaceuticals. 2021; 14(7):678. https://doi.org/10.3390/ph14070678

Chicago/Turabian Style

Crescioli, Giada, Ennio Boscia, Alessandra Bettiol, Silvia Pagani, Giulia Spada, Giuditta V. Vighi, Roberto Bonaiuti, Mauro Venegoni, Giuseppe D. Vighi, Alfredo Vannacci, Niccolò Lombardi, and on behalf of the MEREAFaPS Study Group. 2021. "Risk of Hospitalization for Adverse Drug Events in Women and Men: A Post Hoc Analysis of an Active Pharmacovigilance Study in Italian Emergency Departments" Pharmaceuticals 14, no. 7: 678. https://doi.org/10.3390/ph14070678

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