p.56 抽出テキスト

Ezetemibe Lipid-lowering drug - Yes (data in rats and rabbits; no human data available)

Unknown (increased plasma concentration in nursing rat pups)

Inadequate human data • use only when benefit outweighs risk Animal data: • no evidence of embryolethal effects in rats and rabbits • increased incidence of common foetal skeletal findings in rats (at 10 the human exposure at 10 mg/day) • increased incidence of extra thoracic ribs in rabbits (at 150 the human expo- sure at 10 mg/day) • combination with statins in rats and rabbits during organogenesis results in higher ezetimibe and statin exposure Fenofibrate Lipid-lowering drug C Yes Yes Inadequate human data • use only when benefit outweighs risk Animal data: • embryocidal and teratogenic in rats (7–10 MRHD) and embryocidal in rabbits (9 MRHD) • in rats (9 MRHD before and throughout gestation): delayed delivery, increased post-implantation loss, decreased litter size, decreased birth weight, 40% survival of pups at birth, 4% survival of pups as neonates, 0% survival of pups to weaning, increase in spina bifida • increase in foetal gross, visceral, and skeletal findings in rats (10 MRHD on day 6–15 of gestation) • delayed delivery, 40% decrease in live births, 75% decrease in neonatal survival, decreased pup weight in rats (7 MRHD from day 15 of gestation through weaning) • abortions in 10–25% of dams (9–18 MRHD), death in 7% of foetuses (18 MRHD). Flecainide Antiarrhythmic (Class IC)

C Yes Yesb Inadequate human data Animal data: • teratogenic effects (e.g. club paws, sternebral and vertebral abnormalities, pale hearts with contracted ventricular septa) and an embryotoxic effect (e.g. increased resorptions) in one breed of rabbit (New Zealand White) but not in another (Dutch Belted) (4 MRHD) • no teratogenic effects in rats or mice (at 50 and 80 mg/kg/day, respectively), but delayed sternebral and vertebral ossification at high dose in rats Continued Downloaded from academic.oup.com/eurheartj/article/39/34/3165/5078465 by guest on 07 October 2026