Zontivity Pregnancy Warnings
Use should be avoided.
US FDA pregnancy category: Not assigned.
Risk Summary: Insufficient data exist to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Comments: If pregnancy is detected, discontinue this drug and initiate appropriate alternative therapy.
Animal studies have failed to reveal evidence of embryofetal 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
