LetibotulinumtoxinA Pregnancy and Breastfeeding Warnings

Brand names: Letybo

LetibotulinumtoxinA Pregnancy Warnings

According to some authorities: This drug should not be used during pregnancy.

AU TGA pregnancy category: B3
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. Based on animal data, this drug may result in adverse effects on fetal growth.

Animal studies have revealed evidence of adverse effects on fetal growth (e.g., reduced fetal weights, minor skeletal/visceral variations) when this drug was administered intramuscularly during the period of organogenesis at doses 3 times the maximum recommended human dose. Treatment-related adverse fetal effects were associated with maternal toxicity. Fertility studies have not been conducted; however, decreased fertility occurred at higher doses in animals, with resultant signs of toxicity. 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.

See references

LetibotulinumtoxinA Breastfeeding Warnings

According to some authorities: Use is not recommended.

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

Comments:
-There are no data on the presence of this drug in human milk; however, according to some experts, excretion into breastmilk is unlikely because botulin A was undetectable systemically after intramuscular use.
-There is no information on the effects of this drug on the breastfed infant or the effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug, as well as any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer