Bevyxxa Pregnancy Warnings
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
US FDA pregnancy category: Not assigned
Comments:
-Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery.
-Consider the risks of bleeding and stroke in using this drug in pregnancy.
Animal studies showed no embryofetal or teratogenic effects at up to 44 times the human dose, however at the highest doses fetal deaths were seen due to maternal toxicity. 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.
See references
Bevyxxa Breastfeeding Warnings
The manufacturer makes no recommendation regarding use during lactation.
Excreted into human milk: Data not available
Excreted into animal milk: Data not available
Comments:
-Consider the benefits of breastfeeding along with potential adverse effects on the infant and the underlying maternal condition.
See references
