The Pregnancy and Lactation Labeling Rule (PLLR) – News Block

Data on the reproductive safety of benzodiazepines have always been somewhat difficult to understand. Although previous studies have suggested an increased risk of cleft lip and/or palate in children exposed to benzodiazepines during pregnancy, more recent studies have not shown any increased risk of birth defects. A new study from the MGH Center for Women’s Mental Health adds to our data on benzodiazepine use during pregnancy.

Using data from the MGH National Pregnancy Registry for Psychiatric Medications (NRPPM), Mercedes Szpunar, MD, PhD, Marlene Freeman, M.D.and colleagues at the MGH Center for Women’s Mental Health examined the risk of major malformations after benzodiazepine exposure in the first trimester.

Data were collected from the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications, which prospectively enrolls pregnant women with psychiatric illnesses who are taking one or more psychiatric medications. Participants are interviewed twice during pregnancy and at 12 weeks postpartum. The researchers identified women who were taking any benzodiazepine during the first trimester of pregnancy and compared them to a group of women who were taking psychiatric medications other than benzodiazepines during pregnancy.

From this registry, a total of 1053 women were eligible for this analysis, including a total of 151 women who had taken a benzodiazepine during the first trimester of pregnancy and a comparison group of 902 women who did not use benzodiazepines. There was no difference in the risk of major malformations between the two groups. There were five major malformations in the exposure group (3.21%) and 32 in the comparison group (3.46%; odds ratio 0.92, 95% confidence interval 0.35-2.41).

Data from this ongoing pregnancy registry provide reassurance that benzodiazepines do not appear to have significant teratogenic effects. The registry continues to grow in size and the precision of the relative risk estimates will improve as the number of participants increases.

National Pregnancy Registry for Psychiatric Medications

Women currently taking or planning to take any type of psychiatric medication during pregnancy may consider participating in the National Pregnancy Registry for Psychiatric Medications. (This study does not require in-person visits.)

He National Pregnancy Registry for Psychiatric Medications is dedicated to evaluating the safety of psychiatric medications such as antidepressants, ADHD medications, and atypical antipsychotics that many women take during pregnancy to treat a wide range of mood, anxiety, executive function, or psychiatric disorders . The purpose of this registry is to collect information on the safety of these drugs during pregnancy, as current data for many drugs are limited.

Ruta Nonacs, M.D. PhD

Szpunar MJ, Freeman MP, Kobylski LA, Caplin PS, Gaccione P, Viguera AC, Chitayat D, Hernández-Díaz S, Cohen LS. Risk of major malformations in infants after benzodiazepine exposure in the first trimester: results from the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications. depressive anxiety December 2022; 39(12):751-759.