Rhofade Pregnancy Warnings
The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not assigned.
Risk Summary: No data available on use of this drug in pregnant women to inform a drug-related risk.
Animal models have revealed evidence of delayed skeletal ossification, increased pup mortality, and decreased pup weight at maternally toxic doses. There are no controlled data in human pregnancy. There is a theoretical association between renal collecting system anomalies and second-trimester exposure in patients using intranasal formulations.
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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