Adverse Drug Events by Sex After Adjusting for Baseline Rates of Drug Use

• Type of Material: Article
• Authors: Tamara Rushovich, Harvard University; Annika Gompers, Emory University; Jeffrey W. Lockhart, University of Chicago; Ife Omidiran, Harvard University; Steven Worthington, Harvard University; Sarah S. Richardson, Harvard University; Katharine M. N. Lee, Tulane University
• Language: English
• Date: 2023-08-21
• Publisher: AMER MEDICAL ASSOC
• Publication Version: Final Published Version
• Copyright Statement: 2023 Rushovich T et al. JAMA Network Open.
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1001/jamanetworkopen.2023.29074
• Title of Journal or Parent Work: JAMA NETWORK OPEN
• Volume: 6
• Issue: 8
• Start Page: e2329074
• End Page: e2329074
• Grant/Funding Information: This study was supported by grant 79892 from the Robert Wood Johnson Foundation’s Pioneering Ideas program. Dr Lockhart was supported by a grant from the James S. McDonnell Foundation.
• Keywords: Medicine, General & Internal; Science & Technology; Life Sciences & Biomedicine; General & Internal Medicine
• Research Categories: Gender Studies; Chemistry, Pharmaceutical

Abstract

Although they have known limitations,1 spontaneous reporting pharmacovigilance databases like the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and World Health Organization VigiBase are widely cited as evidence for claims that women experience adverse drug events (ADEs) at as high as twice the rate of men.2,3 Pharmacokinetics and pharmacodynamics are typically used to explain these sex differences2; however, many factors could influence the distribution of ADE reports by sex, including well-known disparities in the rates at which men and women use prescribed drugs.4 This study examined ADEs reported by sex in the FAERS database after adjusting for drug use by men and women. Information regarding how sex and gender are conceptualized in this study and its data sources appears in Supplement 1.