Use is not recommended unless clearly needed

AU TGA pregnancy category: B2
US FDA pregnancy category: Not formally assigned

Risk Summary: Safe use in pregnancy has not been established

In a large prospective study of 2323 exposures during the first trimester, atropine-related drugs as a whole were possibly associated with minor fetal malformations. However, only 4 of those exposures were to benztropine. A surveillance study of Michigan Medicaid recipients recorded 84 newborns exposed to benztropine during the first trimester between 1985 and 1992. Four major birth defects were noted (three expected). Three were cardiovascular defects (one expected), suggesting a possible association with benztropine exposure. Paralytic ileus has been reported in 2 newborns exposed to chlorpromazine and benztropine. In one case, other anticholinergic agents had also been administered to the mother. The condition resolved rapidly in both infants following a Gastrografin enema. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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Caution is recommended

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

There is no information on the use of this drug during breastfeeding. Anticholinergic agents may inhibit lactation in animals by inhibiting growth hormone and oxytocin secretion. Prolactin levels in mothers with established lactation may not affect her ability to breastfeed.

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