Entacapone Pregnancy Warnings
AU: Use is contraindicated
UK: Use is not recommended
US: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
AU TGA pregnancy category: B3
US FDA pregnancy category: C
Animal studies have shown increased frequencies of abortions, late/total resorptions, and decreased fetal weights in litters of rabbits receiving 100 mg/kg/day. Administration of 160 mg/kg/day to female rats prior to mating and during early gestation have shown an increased incidence of fetal eye anomalies (macrophthalmia, microphthalmia, and anophthalmia). This drug is always given concomitantly with levodopa and carbidopa, which is known to cause visceral and skeletal malformations in rabbits. The teratogenic potential of combination therapy with levodopa/carbidopa has not been assessed in animal studies. There are no controlled data in human pregnancy.
AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
See references
