Trofinetide Pregnancy Warnings
In animal studies, oral administration of this drug to pregnant animals did not result in any adverse effects on embryofetal, prenatal, or postnatal development. There are no controlled data in human pregnancy.
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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.
Safety has not been established in pregnant women.
US FDA pregnancy category: Not assigned.
Risk summary: Inadequate data available on use of this drug in pregnant women to inform a drug-related risk.
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