Savaysa Pregnancy Warnings
Use is contraindicated per some authorities.
US FDA pregnancy category: Not assigned.
Risk Summary: Insufficient data exist to determine whether there are drug-associated risks for adverse developmental outcomes.
Animal studies revealed embryofetal toxicity at maternotoxic 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.
See references