| アブストラクト | OBJECTIVE: Little is known regarding the safety of ifosfamide in pregnant women and some case reports were associated with oligohydramnios. In the study, we performed a comprehensive analysis of the available data regarding the safety of ifosfamide in pregnant women. MATERIAL AND METHODS: First, we performed a case-by-case review of the cases related to ifosfamide use during pregnancy that were spontaneously reported in the French Pharmacovigilance Database. Second, we reviewed cases from the literature. Finally, we performed a disproportionality analysis on VigiBase, the WHO global safety database (VigiBase), to assess the association between ifosfamide and selected adverse events in pregnant women. RESULTS: A total of 27 cases of ifosfamide use during pregnancy were identified. No congenital malformation was reported. Main adverse events were intrauterine growth restriction (n = 15, 56 %) and oligohydramnios or anhydramnios (n = 15, 56 %). Pregnancy resulted in intrauterine fetal death in 5 (19 %) cases, all being treated with ifosfamide before the 21th week of gestation. All livebirths (n = 22) were preterm, associated with neonatal acute renal failure in 5 (23 %) cases. In addition, 3 (14 %) neonatal deaths were reported within the first week of life in neonates having anuria. In VigiBase, which has over 263,145 spontaneous safety reports related to pregnancy, we found a significant increased reporting of oligohydramnios, intrauterine growth restriction and neonatal acute renal failure with ifosfamide compared to other antineoplastic agents. CONCLUSION: Altogether, this comprehensive analysis supports that ifosfamide may induce fetal nephrotoxicity in pregnant women. It can result in intrauterine growth restriction, oligohydramnios and neonatal acute renal failure, as well as fetal death especially for early exposure during the first half of pregnancy. |
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| ジャーナル名 | European journal of obstetrics, gynecology, and reproductive biology |
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| Pubmed追加日 | 2025/5/5 |
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| 投稿者 | Devant, Charlotte; Pietri, Tessa; Auffret, Marine; Lagarce, Laurence; Barrois, Mathilde; Treluyer, Jean-Marc; Tsatsaris, Vassilis; Chouchana, Laurent |
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| 組織名 | Centre Regional de Pharmacovigilance, Service de Pharmacologie perinatale,;pediatrique et adulte, Hopital Cochin, Assistance Publique-Hopitaux de Paris;(AP-HP), Paris, France.;Centre Regional de Pharmacovigilance et d'information sur le medicament,;Assistance Publique Hopitaux de Marseille Aix Marseille Universite, Marseille,;France.;Service hospitalo-universitaire de pharmacotoxicologie, centre regional de;pharmacovigilance, Hospices civils de Lyon, UMR CNRS 5558, universite de Lyon 1,;69000 Lyon, France.;Departement de pharmacologie, toxicologie et pharmacovigilance, CHU d'Angers,;Angers, France.;Maternite Port-Royal, FHU PREMA, AP-HP, Hopital Cochin, Universite Paris Cite,;75014 Paris, France.;(AP-HP), Paris, France; Universite Paris Cite, INSERM UMR-S 1343, Pharmacologie;et evaluations des therapeutiques chez l'enfant et la femme enceinte, F-75006;Paris, France.;Paris, France. Electronic address: laurent.chouchana@aphp.fr. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40319762/ |
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