Moban Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
US FDA pregnancy category: Not formally assigned to a pregnancy category.
Risk Summary: There are no data available on use of this drug in pregnant women to inform of a drug-related risk.
Comment:
-Neonates exposed during the third trimester should be closely monitored, as they are at risk of extrapyramidal/withdrawal symptoms after delivery (e.g., agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, feeding disorder).
Animal study data have revealed evidence of a slight increase in resorptions at doses of at least 20 mg/kg/day given for 10 days. 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.
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