Gepirone Pregnancy and Breastfeeding Warnings

Brand names: Exxua

Gepirone Pregnancy Warnings

Safety has not been established in pregnancy; benefit should outweigh risk.

US FDA pregnancy category: Not assigned

Risk summary: Insufficient data are available on use of this drug in pregnant women to inform a drug-related risk. Based on animal studies, this drug may cause fetal harm when administered to a pregnant woman.

Comments:
-Use of serotonergic antidepressants during the third trimester may increase the risk for persistent pulmonary hypertension (PPHN) and symptoms of poor adaptation in the neonate.
-Health care providers should consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.
-A pregnancy exposure registry is available.

Animal studies have revealed evidence of adverse effects on embryofetal and postnatal development. Decreased embryofetal growth, decreased body weights and lengths, and skeletal variations were observed in animals at doses at least 18 to 24 times the maximum recommended human dose (MRHD) when administered during the period of organogenesis. Evidence of malformations were not observed in these studies. In animal studies from late gestation through weaning, decreased birth weights were seen at doses approximately twice the MRHD or higher; increased offspring mortality within 4 days of birth and persistent body weight reduction were seen it all doses tested, including doses equal to MRHD. When this drug was administered to animals prior to and throughout mating, gestation, and lactation, there was an increase in still births, early postnatal mortality, decreased fetal weights and lengths, and a delay of developmental landmarks observed at doses 3 times the MRHD and above. The no observed adverse effect limit (NOAEL) for fetal effects and growth and development across studies was associated with maternal doses that ranged from below to 12 times the MRHD. In animal fertility studies, impairment (i.e., latency to mating) was observed at doses 8 times the MRHD and above.

Limited data in human pregnancy suggests that fetal exposure during late pregnancy to serotonergic antidepressants may pose an increased risk of PPHN. Neonates exposed to other serotonergic antidepressants in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding; these complications can arise immediately upon delivery. Clinical findings associated with serotonergic antidepressant exposure during late pregnancy are consistent with either a direct toxic effect of selective serotonin reuptake inhibitors or possibly a drug discontinuation syndrome, which in some cases is clinically consistent with serotonin syndrome.

There are also maternal and embryofetal risks associated with depression in pregnancy. A prospective, longitudinal study in pregnant women with a history of major depressive disorder observed that euthymic women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued therapy.

To monitor the outcomes of pregnant women exposed to antidepressants, including this drug, a pregnancy registry has been established. Health care providers are encouraged to register patients and pregnant women are encouraged to register themselves by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Gepirone Breastfeeding Warnings

Safety has not been established; benefit should outweigh risk.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-The developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-Breastfed infants are unlikely to absorb large amounts of this drug due to poor oral bioavailability.
-Until more data become available, caution is recommended, particularly while breastfeeding newborn or preterm infants.
-There are reports of adverse effects in breastfed infants exposed to other serotonergic antidepressants.
-Closely monitor breastfed infants for adverse effects such as irritability, restlessness, excessive somnolence, decreased feeding, and weight loss.
-When a drug is present in animal milk, it is likely to be present in human milk.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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