Bloxiverz Pregnancy Warnings
Benefit should outweigh risk.
AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned.
Risk Summary: It is not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
Comments:
-Cholinesterase inhibitor drugs may cause uterine irritability and induce premature labor when administered to pregnant women near term.
Animal studies have revealed no evidence of adverse effects when this drug was administered during organogenesis at equivalent human doses. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.
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
Bloxiverz Breastfeeding Warnings
Limited data indicate that use of this drug to treat myasthenia gravis may be acceptable during breastfeeding, although pyridostigmine may be preferred. Because of its short half-life, single doses to reverse neuromuscular blockade following surgery are unlikely to adversely affect the breastfed infant more than transiently.
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-Monitor newborns because abdominal cramps after each breastfeeding has been reported.
See references
