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. 2021 Jun;77(6):913-919.
doi: 10.1007/s00228-020-03064-y. Epub 2020 Dec 19.

Renal ischemic adverse drug events related to tranexamic acid in women of child-bearing age: an analysis of pharmacovigilance data

Dominik Stämpfli  1 , Stefan Weiler  2   3 , Carolyn F Weiniger  4 , Andrea M Burden  2 , Michael Heesen  5
Affiliations

Renal ischemic adverse drug events related to tranexamic acid in women of child-bearing age: an analysis of pharmacovigilance data

Dominik Stämpfli et al. Eur J Clin Pharmacol. 2021 Jun.

Abstract

Purpose: In response to a large trial, the World Health Organization broadened their recommendation on tranexamic acid to be used for post-partum hemorrhage. A 2013 French periodic safety update report warned of an abnormally high rate of renal cortical necrosis associated with tranexamic acid and other drugs for severe post-partum hemorrhage. We aimed to identify the reporting incidence of adverse thrombo-embolic events among women in child-bearing age who received tranexamic acid, with a focus on renal vascular and ischemic conditions.

Methods: We analyzed individual case safety reports (ICSRs) on renal vascular and ischemic conditions, pulmonary thrombotic and embolic conditions, and peripheral embolism and thrombosis from the database of the World Health Organization - Uppsala Monitoring Centre (WHO-UMC). ICSRs were restricted to reports including tranexamic acid as a suspected drug, sex reported as female, and reported age between 18 and 44 years. Reporting odds ratios (RORs) and 95% confidence intervals (95% CIs) were calculated by comparing ICSRs on tranexamic acid to all other drugs in VigiBase.

Results: Within 2245 included ICSRs on tranexamic acid, we identified 29 reports of adverse renal vascular and ischemic conditions, 42 reports of pulmonary thrombotic and embolic conditions, and 41 reports of peripheral embolism and thrombosis. RORs were statistically significant by 32.6-fold (32.62, 95% CI: 22.50-47.29), 2.5-fold (2.52, 95% CI: 1.85-3.42), and 2.7-fold (2.67, 95% CI: 1.96-3.64), respectively, when compared to any other drug within VigiBase.

Conclusion: Tranexamic acid might bear an increased risk for renal ischemic adverse drug events in women of child-bearing age.

Keywords: Obstetrics; Post-partum hemorrhage; Renal cortical necrosis; Tranexamic acid.

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Conflict of interest statement

The authors declare that they have no conflicts of interest relevant to the content of this study. SW is a member of the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA). The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.

The authors declare that they performed their research in compliance with the caveat document “Statement of reservations, limitations and conditions relating to data released from VigiBase, the WHO global database of individual case safety reports (ICSRs)” by the WHO Collaborating Centre for International Drug Monitoring, Uppsala Monitoring Centre, published 2018-11-20 on www.who-umc.org.

Figures

Fig. 1
Fig. 1
Top three reported concomitant medication and reported reactions within individual case safety reports (ICSRs) on tranexamic acid in VigiBase, stratified by all and the events of interest. ICSRs were filtered for tranexamic acid reported as suspected drug, female sex, and reported age 18 to 44 years. Numbers may not add up to 100%: An ICSR may report more than one concomitant medication
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