In animal studies that included rats and rabbits, this drug produced embryo-fetal toxicity at doses lower than or similar to the maximum recommended human dose. There are no controlled data in human pregnancy.

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.

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

US FDA pregnancy category: Not assigned

Risk Summary: There are no human data to establish the presence or absence of drug-associated risk in pregnant women.

See references

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

No data exist on the medical use of this drug during breastfeeding, although medical use is not expected to produce measurable blood levels and therefore it would not be expected to be available for secretion into breast milk.

There is a report of a mother who contracted botulism and successfully breastfed her infant. On admission to the hospital, type A botulinum toxin was detected in her blood and stools; none was detected in the infant's stools. The mother was treated with 2 vials of trivalent botulism antitoxin (IV and IM). A milk sample obtained 4 hours after administration of the antitoxin had no detectable botulinum toxin or botulism organisms.

See references