Fetal Risk Summary
I-Hyoscyamine is an anticholinergic agent. No published reports of its use in pregnancy have been located (see also Belladonna or Atropine).
In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 281 newborns had been exposed to I-hyoscyamine during the 1st trimester (F. Rosa, personal communication, FDA, 1993). A total of 12 (4.3%) major birth defects were observed (11 expected). Specific data were available for six defect categories, including (observed/expected) 1/3 cardiovascular defects, 0/0.5 oral clefts, 0/0 spina bifida, 0/1 hypospadias, 2/1 polydactyly, and 2/0.5 limb reduction defects. Only with the latter two defects is there a suggestion of a possible association, but other factors, including the mother’s disease, concurrent drug use, and chance, may be involved.
Breast Feeding Summary