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: Not assigned

Comments:
-There is no data on use in pregnant women to know this drugs risks.
-Animal studies during organogenesis at oral doses up to 133 times the maximum recommended human dose (MRHD) did not show increased gross external or visceral defects; intravenous doses up to 7.8 the MRHD had no adverse embryo-fetal developmental effects; inhaled doses up to 1521 the maximum recommended human daily inhalation dose (MRHDID) showed no teratogenicity.

Animal studies during organogenesis at oral doses from 2.5 to up to 133 times the maximum recommended human dose (MRHD) had no effect on maternal survival but significantly reduced maternal weight gain at all doses, with mean fetal weight significantly reduced at 23 and 113 times the MRHD, and 2 litters were completely resorbed at 113 times the MRHD; oral doses 113 times the MRHD did not show increased gross external or visceral defects, but minor treatment related skeletal effects (reduced ossification), likely due to maternal toxicity, occurred at 23 and 113 times the MRHD. Intravenous doses of 0.8, 4.6, and 7.8 times the MRHD did not affect maternal survival, but mean maternal body weight gain and food consumption was reduced in the 4.6 and 7.8 times MRHD dose, but there were no effects on fetal parameters (including survival, mean weight, and incidence of external, visceral, or skeletal defects). Inhalation doses up to 1521 times the maximum recommended human daily inhalation dose (MRHDID) during organogenesis showed no teratogenicity. No peri- or post-natal developmental problems were seen at subcutaneous doses up to 1521 the MRHDID. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-As an anticholinergic, this drug may suppress lactation.
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references