Parnate Pregnancy Warnings
Use is recommended only if clearly needed and the benefit outweighs the risk.
AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned
Risk Summary: No data are available on use of this drug in pregnant women to inform a drug-related risk.
Comments:
-A pregnancy exposure registry is available.
-Neonates exposed to antidepressants late in the third trimester have shown drug withdrawal symptoms such as dyspnea, lethargy, colic irritability, hypotension or hypertension, and tremor or spasms.
Animal studies have shown that this drug crosses the placental barrier, but are insufficient with regard to reproductive toxicity. There are no controlled data in human pregnancy. Epidemiological studies suggest an increased risk of congenital abnormalities with antidepressant use during pregnancy as well as an increase in pre-term delivery.
To monitor maternal-fetal outcomes of pregnant women exposed to antidepressant therapy, a National Pregnancy Registry for Antidepressants has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/
AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
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
Parnate Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
-Some experts recommend: This drug should be used only if clearly needed; benefit to mother should outweigh risk to the infant.
Excreted into human milk: Yes
See references
