Arcapta neohaler Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: B3
US FDA pregnancy category: C
Comments:
-Beta-agonists may potentially interfere with uterine contractility; it may inhibit labor due to a relaxant effect on uterine smooth muscle.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposures. A decreased pregnancy rate has been observed in rats. Nevertheless, it is considered unlikely that this drug will affect reproductive or fertility performance in humans following inhalation of the maximum recommended dose.
This drug was not teratogenic at subcutaneous doses up to 1 mg/kg/day in rats and 3 mg/kg/day in rabbits. An increase in the incidence of a rib skeletal variation and retarded ossification were observed in the rabbit at 3 mg/kg/day, possibly secondary to maternal toxicity; embryofetal development was unaffected in the species at 1 mg/kg/day. Impaired learning and decreased fertility were observed in the pups of rats given this drug at a subcutaneous dose of 1 mg/kg/day during pregnancy and lactation. There are no controlled data in human pregnancy, preterm labor or labor at term.
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.
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