Data analysis of VigiBase, the World Health Organization’s (WHO’s) global database of individual cases safety reports between1967 and 2018 indicates important underlying gender-related differences in adverse drug reactions (ADRs). In particular, women from puberty and onwards and especially in their reproductive years, report more ADRs than men. However, there is a higher proportion of serious and fatal ADRs among male reports. The findings are reported in EClinicalMedicine, published by The Lancet.
The ADRs are an important cause of morbidity and mortality. The goal of the study was to assess the global evidence on spontaneous post-marketing ADR reporting differences between reports for women and men.
VigiBase contains more than 18 million reports from the 131 member countries of the WHO Programme for International Drug Monitoring.
Of the reports with information on gender, 9,056,566 (60.1%) concerned female and 6,012,804 (39.9%) male children and adults. More female ADR reports were submitted in all regions of the world and by all types of reporters. A higher proportion of female reports was seen in all age groups from the age group 12-17 years and older. The largest difference was observed in the age group of 18–44 years and could not be explained by hormonal contraceptive use.
The proportion of serious and fatal reports was higher for male reports than female reports using global spontaneous ADR reporting data.
The authors concluded that their findings highlight the importance of considering gender throughout the entire life-cycle of drug development and surveillance and understanding the underlying reasons for reporting ADRs. For example, a balanced inclusion of women and men, as well as gender-stratified analyses of all experienced ADRs, in clinical trials of all phases is warranted. Further, more research is needed to better understand the underlying reasons for the differences in ADR reporting observed in this study.
Watson S, Caster O, Rochon PA, et al. Reported adverse drug reactions in women and men: Aggregated evidence from globally collected individual case reports during half a century. EClinicalMedicine; Published 25 October 2019. https://doi.org/10.1016/j.eclinm.2019.10. 001.