Fetal Risk Summary
Azatadine is not teratogenic in rats and rabbits given doses much higher than human doses (1). Published reports of exposure during human pregnancy have not been located. (See also Diphenhydramine for representative agent in this class.) In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 127 newborns had been exposed to azatadine during the 1st trimester (F. Rosa, personal communication, FDA, 1993). A total of six (4.7%) major birth defects were observed (five expected). Among the six types of defects for which specific data were available, one oral cleft (none expected) and one limb reduction defect (none expected) were observed. No cases of cardiovascular defects, spina bifida, polydactyly, or hypospadias were reported. These data do not support an association between the drug and the defects.
Breast Feeding Summary
No data are available.
- Product information. Optimine. Schering Corporation, 1993.