ArticleEuropean journal of clinical pharmacology2021
Renal ischemic adverse drug events related to tranexamic acid in women of child-bearing age: an analysis of pharmacovigilance data.
Article in European journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed, 3 syntheses or guidelines pooled it, 12 citations in OpenAlex.
- Clinical practice guidelines for management of disseminated intravascular coagulation in Japan 2024: part 4-trauma, burn, obstetrics, acute pancreatitis/liver failure, and others.International journal of hematology · 2025Guideline
- Tranexamic acid for preventing postpartum haemorrhage after vaginal birth.The Cochrane database of systematic reviews · 2025Pooled it
- Tranexamic acid for preventing postpartum haemorrhage after caesarean section.The Cochrane database of systematic reviews · 2024Pooled it
- Effectiveness of tranexamic acid in intervening postpartum vaginal lacerations.BMC pregnancy and childbirth · 2025Trial
- Prophylactic Administration of Tranexamic Acid Reduces Blood Products' Transfusion and Intensive Care Admission in Women Undergoing High-Risk Cesarean Sections.Journal of clinical medicine · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeIn 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.
methodsWe 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.
resultsWithin 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.
conclusionTranexamic acid might bear an increased risk for renal ischemic adverse drug events in women of child-bearing age.
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