Protonix Pregnancy Warnings
Animal models have revealed evidence of changes to femur bone length and weight when given during gestation day 6 through lactation day 21. There are no controlled data in human pregnancy.
AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
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 is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk.
-Some experts state that this drug should not be used in pregnancy.
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.
Risk summary: Observational studies indicate that an association of major malformations or adverse events with use of this drug during pregnancy; however, drug-associated risks cannot definitively be established or excluded by observational studies due to methodological limitations.
See references
Protonix Breastfeeding Warnings
Use is not recommended and 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: Yes (oral); Unknown (parenteral)
Excreted into animal milk: Yes (parenteral)
Comment: The effects in the nursing infant are unknown.
Animal models have evidence of decreased pup weight at doses of at least 10 mg/kg/day. There have been reports of excretion into human breast milk.
See references
