Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Dec;39(12):751-759.
doi: 10.1002/da.23280. Epub 2022 Jul 31.

Risk of major malformations in infants after first-trimester exposure to benzodiazepines: Results from the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications

Mercedes J Szpunar  1   2 , Marlene P Freeman  1   2 , Lauren A Kobylski  1 , Phoebe S Caplin  1 , Peter Gaccione  1 , Adele C Viguera  1   2   3 , David Chitayat  4 , Sonia Hernández-Díaz  5 , Lee S Cohen  1   2
Affiliations

Risk of major malformations in infants after first-trimester exposure to benzodiazepines: Results from the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications

Mercedes J Szpunar et al. Depress Anxiety. 2022 Dec.

Abstract

Background: Perinatal anxiety affects 20% of women, and untreated maternal mental illness can cause deleterious effects for women and their children. Benzodiazepines are commonly used to treat anxiety disorders. The reported risk of congenital malformations after in utero benzodiazepine exposure has been inconsistent.

Methods: The Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications prospectively enrolls pregnant women with psychiatric illness who take one or more psychiatric medications. Participants are interviewed twice during pregnancy and at 12 weeks postpartum. Women taking any benzodiazepine during the first trimester of pregnancy were compared with a group of women taking psychiatric medication(s) other than benzodiazepines during pregnancy.

Results: A total of 1053 women were eligible for this analysis; N = 151 women who had taken a benzodiazepine during the first trimester, and the comparison group was N = 902 women. There were 5 (3.21%) major malformations in the exposure group and 32 (3.46%) in the comparison group (odds ratio 0.92; 95% confidence interval 0.35-2.41).

Conclusion: This ongoing pregnancy registry offers reassurance that benzodiazepines do not appear to have major teratogenic effects. The precision of relative risk estimate will improve as the number of participants increases. This and other pregnancy registries will better inform the reproductive safety of benzodiazepines.

Trial registration: ClinicalTrials.gov NCT01246765.

Keywords: anxiety; pharmacotherapy; pregnancy and postpartum.

PubMed Disclaimer

Similar articles

See all similar articles

Cited by

References

REFERENCES

    1. Avraham, L., Tamar, W., Eyal, S., & Gali, P. (2020). Perinatal outcomes and offspring long-term neuropsychiatric hospitalizations of mothers with anxiety disorder. Archives of Women's Mental Health, 23(5), 681-688.
    1. Ban, L., West, J., Gibson, J. E., Fiaschi, L., Sokal, R., Doyle, P., Hubbard, R., Smeeth, L., & Tata, L. J. (2014). First trimester exposure to anxiolytic and hypnotic drugs and the risks of major congenital anomalies: A United Kingdom population-based cohort study. PLoS One, 9(6), e100996.
    1. Berle, J. Ø., Mykletun, A., Daltveit, A. K., Rasmussen, S., Holsten, F., & Dahl, A. A. (2005). Neonatal outcomes in offspring of women with anxiety and depression during pregnancy. A linkage study from the Nord-Trondelag Health Study (HUNT) and Medical Birth Registry of Norway. Archives of Women's Mental Health, 8(3), 181-189.
    1. Bonnot, O., Vollset, S. E., Godet, P. F., D'Amato, T., & Robert, E. (2001). Maternal exposure to lorazepam and anal atresia in newborns: Results from a hypothesis-generating study of benzodiazepines and malformations. Journal of Clinical Psychopharmacology, 21(4), 456-458.
    1. Centers for Disease Control and Prevention (CDC). (2008). Update on overall prevalence of major birth defects-Atlanta, Georgia, 1978-2005. MMWR. Morbidity and Mortality Weekly Report, 57(1), 1-5.

Publication types

Substances

Associated data