While buspirone (BuSpar) is not used as commonly as serotonin reuptake inhibitors (SRIs) or benzodiazepines for the treatment of anxiety, we do see a fair number of women taking this medication. Because we have not had adequate data regarding the reproductive safety of buspirone, we have typically recommended that women discontinue this medication during pregnancy. A recent study from the Center provides some preliminary information.
Using data from the MGH National Pregnancy Registry for Psychiatric Medications (NPRPM), Marlene Freeman, MD, Mercedes Sxpunar, MD, PhD, and colleagues examined data on the risk of major malformations after first-trimester buspirone exposure. The NPRPM enrolls pregnant women with psychiatric disorders to prospectively assess risk for major congenital malformations after in utero exposure to psychotropic medications.
Women are interviewed twice during pregnancy and again at 12 weeks postpartum. From the NPRPM database, 97 women with first trimester exposure to buspirone were identified. Of these women, 68 were evaluable and eligible for this analysis. Four women had twins, resulting in a total of 72 infants with buspirone exposure. The incidence of major malformations among children exposed to buspirone was obtained using postpartum interviews of the mothers and medical record review.
In this sample, there were no malformations observed. These preliminary data represent the only prospectively ascertained sample of pregnancy outcomes in women with first-trimester exposure to buspirone. While this study provides reassuring data regarding the reproductive safety of buspirone, the sample size is small. It is estimated that approximately 750 subjects with exposure would be required to detect a twofold increase in major malformations, and thousands would be required to detect an increase in the risk of rarer anomalies.
But this is a good start, and the NPRPM (see below) will continue to collect data from women using this medication during pregnancy.
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 requires no in-person visits.)
The 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 goal of this registry is to gather information on the safety of these medications during pregnancy, as current data for many medications is limited.
Ruta Nonacs, MD PhD
Freeman MP, Szpunar MJ, Kobylski LA, Harmon H, Viguera AC, Cohen LS. Pregnancy outcomes after first-trimester exposure to buspirone: prospective longitudinal outcomes from the MGH National Pregnancy Registry for Psychiatric Medications. Arch Womens Ment Health. 2022 Jul 16.
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