Fetal Risk Summary
Simethicone is a silicone product that is used as an antiflatulent. No published reports linking the use of this agent with congenital defects have been located.
In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 248 newborns had been exposed to simethicone during the 1st trimester (F. Rosa, personal communication, FDA, 1993). A total of 14 (5.6%) major birth defects were observed (11 expected). Specific data were available for six defect categories, including (observed/expected) 6/2 cardiovascular defects, 0/0.5 oral clefts, 0/0 spina bifida, 2/1 polydactyly, 0/.5 limb-reduction defects, and 1/0.5 hypospadias. Only the cases of cardiovascular defects suggest a possible association with the drug, but other factors, such as the mother’s disease, concurrent drug use, and chance, are most likely involved.
Breast Feeding Summary
No data are available.