Ethionamide Pregnancy Warnings
Animal studies have revealed evidence of teratogenicity with high doses. 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.
Use should be avoided.
US FDA pregnancy category: Not assigned.
Risk Summary: This drug has teratogenic potential in animal models given doses in excess of those recommended in humans.
Comments:
-Treatment should be withheld in patients likely to become pregnant during therapy unless this drug considers it to be an essential part of treatment.
-The effects on labor and delivery are unknown.
See references
