Ketalar Pregnancy Warnings
In a published report, this drug was clastogenic in the in vitro chromosomal aberration assay. There are no controlled data in human pregnancy.
AU TGA pregnancy category B3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
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.
Use is not recommended.
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned
See references
Ketalar Breastfeeding Warnings
Use is not recommended.
Excreted into human milk: Likely
Excreted into animal milk: Yes
Breastmilk levels of this drug have not been measured after administration to humans. Minimal data indicate that use in nursing mothers may not affect the breastfed infant or lactation. This drug should only be used with careful monitoring during breastfeeding.
See references
