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

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 c...

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Bibliographic Details
Published in:	Pharmaceuticals (Basel, Switzerland) Vol. 14; no. 7; p. 678
Main Authors:	Crescioli, Giada, Boscia, Ennio, Bettiol, Alessandra, Pagani, Silvia, Spada, Giulia, Vighi, Giuditta, Bonaiuti, Roberto, Venegoni, Mauro, Vighi, Giuseppe, Vannacci, Alfredo, Lombardi, Niccolò
Format:	Journal Article
Language:	English
Published:	Basel MDPI AG 15-07-2021 MDPI
Subjects:	Acids Analgesics Anti-inflammatory agents Anticoagulants Benzodiazepines clinical pharmacology Comorbidity Diabetes Edema emergency department female Hospitalization Immunization Insulin male Narcotics Nonsteroidal anti-inflammatory drugs Patients pharmacovigilance Polypharmacy Vaccines Womens health Italy
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Summary:	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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Membership of the MEREAFaPS Study Group is provided in the Acknowledgments. These authors contributed equally to this manuscript.
ISSN:	1424-8247 1424-8247
DOI:	10.3390/ph14070678