Emend Pregnancy Warnings
Oral Formulations: This drug should be used during pregnancy only if clearly needed.
Parenteral Formulations: Use should be avoided.
AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.
Risk summary: There are insufficient data available on use of this drug in pregnant women to inform a drug-related risk.
Comments:
-A reduction in hormonal contraception efficacy may occur during and up to 28 days after treatment.
-Use of adequate methods of non-hormonal contraception should be encouraged during and for up to 1 to 2 months after the last dose.
-Some parenteral formulations contain alcohol; alcohol use during pregnancy is associated with behavioral disorders, central nervous system abnormalities, and intellectual development impairments. There is no safe level of alcohol exposure in pregnancy.
Animal studies have failed to reveal evidence of direct or indirect harm during pregnancy, embryonic/fetal development, parturition, or postnatal development.
There are no controlled data in human pregnancy.
AU TGA pregnancy category B1: 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 have not shown 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
Emend Breastfeeding Warnings
Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comment: The effects in the nursing infant are unknown.
The effects of this drug on milk production is unknown.
See references
