Metformin Pregnancy and Breastfeeding Warnings
Metformin Pregnancy Warnings
Animal studies do not indicate harmful effects with respect to pregnancy, embryo or fetal development, birth or postnatal development. There are no adequate and well-controlled studies in pregnant women. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
This drug should be used during pregnancy only if clearly needed. AU TGA pregnancy category: C US FDA pregnancy category: B
Metformin Breastfeeding Warnings
AU: Use is contraindicated. US and UK: 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 Comments: There is limited data available on the effects in the nursing infant.
Drug levels are expected to be 0.5% of their mother's weight-adjusted dosage and are expected to be relatively constant, therefore timing of breastfeeding with drug administration is expected to be of little benefit. In one large study, no adverse effects were observed in breastfed infants. Low detectable serum levels were found in some breastfed infants. This drug should be used with caution while nursing a newborn or premature infant, especially among those with renal impairment.
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