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Benzodiazepines during pregnancy may be safer than feared. A large US cohort study found that taking benzodiazepines in the first trimester was not linked to a meaningful increase in major congenital malformations. A slight uptick in gastrointestinal defects was noted, but it fell well below the threshold considered clinically significant.
A large population-based cohort study published in Annals of Internal Medicine found reassuring news for pregnant patients on benzodiazepines: first-trimester use was not associated with a substantial increase in major congenital malformations. The study drew on nearly 4.25 million pregnancies across Medicaid and MarketScan databases spanning nearly two decades.
Researchers compared outcomes in pregnancies with at least one filled benzodiazepine prescription during the first trimester against those with no such prescriptions. After adjusting for confounders, the pooled adjusted relative risk for any major congenital malformation was essentially flat (aRR 0.99). A small signal appeared for gastrointestinal malformations (aRR 1.10), but it stayed well below the pre-specified threshold of 1.3 needed to flag a meaningful concern.
Why it matters: Many pregnant patients require treatment for anxiety or seizure disorders, and clinicians have long faced uncertainty about benzodiazepine safety. These findings offer more confidence that first-trimester use doesn't dramatically raise birth defect risk, though researchers caution that further study on other outcomes — like preterm birth — is still needed.