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Lactitol Pregnancy and Breastfeeding Warnings

Lactitol is also known as: Pizensy

Lactitol Pregnancy Warnings

Animal studies have failed to reveal evidence of adverse embryofetal development, adverse fetal/maternal outcomes, major birth defects, or miscarriage when this drug was given during organogenesis at doses at least 0.93 times the maximum daily human dose based on body surface area. 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 drug-related risks of birth defects, miscarriage, or adverse maternal/fetal outcomes.

See references

Lactitol 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: Unknown

Comment: The effects in the nursing infant and on milk production are unknown.

See references

References for pregnancy information

  1. "Product Information. Pizensy (lactitol)." Braintree Laboratories, Braintree, MA.

References for breastfeeding information

  1. "Product Information. Pizensy (lactitol)." Braintree Laboratories, Braintree, MA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.