Drugs in Pregnancy and Lactation: Tenth Edition

SIMETHICONE

Antiflatulent/Defoaming Agent

PREGNANCY RECOMMENDATION: Compatible

BREASTFEEDING RECOMMENDATION: No Human Data—Compatible

PREGNANCY SUMMARY

Simethicone is an over-the-counter nonabsorbable silicone product that is used as an antiflatulent. No published reports linking the use of this agent with congenital defects have been located.

FETAL RISK SUMMARY

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. Although the number of cardiovascular defects was more than expected, simethicone could not have caused them because the drug is not absorbed into the systemic circulation. Other factors, such as the mother’s disease, concurrent drug use, and chance, are most likely involved. Thus, the drug can be classified as compatible in pregnancy.

BREASTFEEDING SUMMARY

No reports describing the use of simethicone during human lactation have been located. There is no risk to a nursing infant from maternal use of the drug as it is not absorbed.



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