Pimavanserin Pregnancy Warnings
Animal studies have failed to reveal evidence of adverse developmental effects and teratogenicity. Maternal toxicity occurred at levels associated with decreased pup survival, litter size, pup weight, and maternal food consumption. 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.
The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not assigned.
Risk Summary: There are no data available on use of this drug in pregnant women to inform of a drug-related risk.
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