p.63 抽出テキスト

• in rabbits: increased incidence of post-implantation pregnancy loss, decreased number of live foetuses, and decreased foetal body weight (doses: 4 human exposure of unbound drug) • in pre-/post-natal rat studies, reduced viability of the offspring at doses toxic to the dams was documented • intrinsic risk of bleeding

Sacubitril/valsartan Angiotensin receptor

neprilysin inhibitor - Unknown Yes (excreted in the milk

of lactating rats) Contraindicated

• can cause foetal harm • sacubitril: inadequate human data Animal data: • rabbits: decreased foetal body weight and skeletal malformations (5.7 MRHD) • rats: no embryofoetal toxicity or teratogenicity at 2.2 MRHD • valsartan: renal or tubular dysplasia, oligohydramnion, growth retardation, ossifi- cation disorders of skull, lung hypoplasia, contractures, large joints, anaemia, and intrauterine foetal death • sacubitril/valsartan: rats/rabbits: increased embryofoetal toxicity, low incidence of foetal hydrocephaly with maternally toxic doses, cardiomegaly (rabbits) at maternally non-toxic doses, foetal skeletal variations (rabbits) • adverse embryofoetal effects are attributed to ARBs Selexipag IP-receptor agonist - Unknown Unknown Inadequate human data Animal data: • rats: no adverse developmental effects in the foetus up to 47 MRHD, slight reduction in foetal and maternal body weight at the high dose • rabbits: no adverse developmental effects in the foetus up to 50 MRHD Sildenafil Phosphodiesterase

type 5 inhibitor B Unknown Unknown Inadequate human data Animal data: • no teratogenicity, embryotoxicity, or foetotoxicity in rats (20 MRHD) and rab- bits (40 MRHD) during organogenesis Sotalol Antiarrhythmic (Class III)

B Yes Yesb Bradycardia and hypoglycaemia Animal data: • no teratogenic potential in rats (9 MRHD) and rabbits (7 MRHD) • rabbits: a high dose of sotalol hydrochloride (6 MRHD) produced a slight increase in foetal death, likely due to maternal toxicity • rats (18 MRHD): increased number of early resorptions Continued Downloaded from academic.oup.com/eurheartj/article/39/34/3165/5078465 by guest on 07 October 2026