Linzess Pregnancy Warnings
Animal studies have revealed adverse fetal effects only with maternal toxicity and at doses much higher than the maximum recommended human dose. 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.
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
US FDA pregnancy category: Not assigned.
Risk Summary: Data on use of this drug in pregnant women is not sufficient to inform a drug-related risk.
Comment: Use of adequate methods of contraception should be encouraged, as oral contraceptive efficacy may be decreased.
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Linzess Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comment: The effects in the nursing infant are unknown.
The drug and its active metabolite are not measurable in plasma following administration of the recommended clinical doses.
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