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A population-based cohort study found that pregnant people who used benzodiazepines during the first trimester were not at a substantially increased risk of having a baby with major birth defects. The rates of overall major congenital malformations were comparable between pregnancies exposed to benzodiazepines and those that were not, providing reassuring evidence about the safety of these medications in early pregnancy. The study is published in Annals of Internal Medicine.

Researchers from Brigham and Women's Hospital and Harvard Medical School and colleagues analyzed data from a cohort of 4.2 million Medicaid and commercially insured pregnancies between 2000 and 2020 to assess the risk of major congenital malformations from first-trimester exposure to benzodiazepines. They compared outcomes among 79,000 people who filled at least one benzodiazepine prescription in early pregnancy with those who did not.

The investigators found no meaningful increase in the risk of overall major birth defects and no consistent evidence of organ-specific malformations previously thought to be associated with benzodiazepine exposure.

While the authors concluded that first-trimester benzodiazepine exposure was not associated with a meaningful increase in birth defect risk, they note that the safety of benzodiazepine use during pregnancy warrants further research to continue monitoring rare birth defects and longer exposures and to examine other pregnancy outcomes.

Benzodiazepine Use Early in Pregnancy and Risk for Congenital Malformations, Annals of Internal Medicine (2026).

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