Kalbitor Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk.
US FDA pregnancy category: Not assigned
Risk Summary: Pharmacovigilance data for this drug have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; studies in rats with doses approximately 1.6 times the maximum recommended human dose (MRHD) resulted in increased early fetal deaths in the presence of maternal toxicity.
An animal reproduction study revealed early fetal deaths and mild maternal toxicity in rats following treatment during the period of organogenesis at an intravenous dose 1.6 times the maximum recommended human dose. Other studies in rats and rabbits showed no effects on embryofetal survival or structural abnormalities.
There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.
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.
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