| アブストラクト | BACKGROUND: Disproportionality analyses in the Food and Drug Administration Adverse Events Reporting System (FAERS) and EudraVigilance reported lower reporting of venous thromboembolism (VTE) with natural estrogen-based combined oral contraceptives (COCs) than with ethinylestradiol/levonorgestrel. However, using ethinylestradiol/levonorgestrel as the reference showed reduced reporting only for natural estrogen-based products. We therefore reanalyzed both databases separately, using natural estrogen-based COCs as the reference. METHODS: Previously extracted individual case safety report datasets and published disproportionality analyses were re-examined, using natural estrogen-based contraceptives as the comparator. Proportional reporting ratios (PRRs) were recalculated separately for each database. COCs were categorized as ethinylestradiol-based or natural estrogen-based formulations. Drospirenone-only pills were included for comparison. Analyses used pooled natural estrogen contraceptives, estetrol/drospirenone, or estradiol/dienogest as reference groups. Disproportionality was defined as PRR >2, at least 3 cases, and chi(2) >/= 4. DISCUSSION: Consistent patterns were observed in EudraVigilance and FAERS. Compared with natural estrogen-based COCs, ethinylestradiol-based COCs showed a disproportionate reporting of VTE (EudraVigilance: PRR, 5.10 [95% CI, 4.68-5.56]; FAERS: PRR, 4.21 [95% CI, 3.49-5.08]). In EudraVigilance, when using estetrol/drospirenone as the reference, all ethinylestradiol-based formulations showed disproportionality according to the conventional PRR threshold. A similar trend was noted in FAERS, though not statistically significant, with the drospirenone-only formulation comparable to estetrol/drospirenone. CONCLUSION: This analysis revealed a consistent and disproportionate reporting of VTE associated with ethinylestradiol-based COCs compared with natural estrogen-based alternatives across 2 pharmacovigilance databases. These results, together with prior biological and observational research, support further reevaluation of COC options given the estrogenic component's potential influence on VTE risk. |
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| ジャーナル名 | Research and practice in thrombosis and haemostasis |
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| Pubmed追加日 | 2026/10/31 |
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| 投稿者 | Raskin, Lucie; Didembourg, Marie; Locquet, Medea; Morimont, Laure; Beaudart, Charlotte; Dogne, Jean-Michel; Douxfils, Jonathan |
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| 組織名 | Research Unit in Clinical Pharmacology and Toxicology, Namur Research Institute;for Life Sciences (NARILIS), Faculty of Medicine, University of Namur, Namur,;Belgium.;Public Health Aging Research & Epidemiology (PHARE) Group, Research Unit in;Clinical Pharmacology and Toxicology, Namur Research Institute for Life Sciences;(NARILIS), Faculty of Medicine, University of Namur, Namur, Belgium.;Department of Biological Hematology, CHU Clermont-Ferrand, Hopital Estaing,;Clermont-Ferrand, France. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42965049/ |
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