In published developmental studies in pregnant mice, administration of this drug at 1, 2.6, and 4.1 times the maximum recommended human dose (MRHD) from 7-days prior to gestation through lactation showed reduced fetal weights, postnatal weight gain, and postnatal survival at 2.6 and 4.1 times MRHD. Retrospective case-control and cohort studies with meprobamate use during the first trimester have not identified and increased risk or pattern of major birth defects. Children exposed to meprobamate in-utero have not shown negative mental, motor development, or IQ score effects. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: Use of this drug over many decades have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes; meprobamate (the primary metabolite) has also not shown a consistent association between maternal use and an increased risk of major birth defects

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Caution is recommended

Excreted into human milk: Yes

Comment: Monitor infant for signs of sedation.

From 1 case report, the average dose an exclusively breastfed infant would receive was calculated at 3 mg/kg/day or about 6% of the maternal weight-adjusted dose. In animal lactation studies in mice, female pup survival and weight at weaning were decreased. This data suggests that maternal use of this drug may lead to reduced or less effective infant feeding due to sedation and/or decreased milk production.

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