p.59 抽出テキスト

Ivabradine If-channel blocker - Yes (transferred to pla-

centa in rats) Yes (animal studies show

excretion in breast milk; contraindicated in breastfeeding)

Inadequate human data • contraindicated Animal data: • exposure close to therapeutic doses showed a higher incidence of foetal cardiac defects in the rat and a small number of foetuses with ectrodactyly in the rabbit drug of choice for hypertension • intrauterine growth retardation (second and third trimesters), neonatal brady- cardia and hypotension (used near term), hypoglycaemia Labetalol a/b-blocker C Yes Yesb Animal data: • rats and rabbits (4 or 6 MRHD): no foetal malformations Levosimendan Calcium sensitizer - Unknown Yes (animal studies show excretion in breast milk)

Inadequate human data Animal data: • generalized reduction in the degree of ossification in rat and rabbit foetuses, with anomalous development of the supraoccipital bone in the rabbit • administration before and during early pregnancy decreased the number of cor- pora lutea, implantations, and pups per litter, and increased the number of early resorptions and post-implantation losses in the female rat (effects were seen at clinical exposure levels)

Lidocaine Antiarrhythmic (Class IB)

C Yes Yesb Foetal bradycardia, acidosis, central nervous system toxicity Animal data: • reproduction studies in rats (6 RHD): no evidence of harm to the foetus

Macitentan Endothelin receptor antagonist

X Unknown Yes (animal studies show excretion in breast milk)

Contraindicated • no human data Animal data: • teratogenic in rabbits and rats at all doses tested, cardiovascular and mandibular arch fusion abnormalities • reduced pup survival and impairment of reproductive capability of offspring (6 RHD during late pregnancy/lactation) Methyldopa Central alpha-agonist B Yes Yesb Mild neonatal hypotension • no teratogenic effects in recently published prospective observational cohort study (first trimester exposure, n = 261), but higher risk of pre-term birth389 Animal data • mice (16.6 MRHD), rats (1.7 MRHD), and rabbits (3.3 MRHD): no evidence of foetal harm Continued Downloaded from academic.oup.com/eurheartj/article/39/34/3165/5078465 by guest on 07 October 2026