Ofev Pregnancy Warnings
Animal studies have revealed evidence of embryotoxicity and teratogenicity. 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 D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
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 contraindicated.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Risk Summary: Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. There are no data on the use of this drug during pregnancy. In animal studies during organogenesis, it caused embryofetal deaths and structural abnormalities at less than the maximum recommended human dose.
Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
See references
Ofev Breastfeeding Warnings
Use is not recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
-The effects in the nursing infant are unknown.
-The manufacturer recommends that breastfeeding be discontinued while taking this drug.
No information is available on the use of this drug during breastfeeding. Because it is more than 97% bound to plasma proteins, the amount in milk is likely to be low; however, its half-life is about 9.7 hours and it might accumulate in the infant.
See references
