Metformin / repaglinide Pregnancy and Breastfeeding Warnings

Brand names: PrandiMet

Metformin / repaglinide Pregnancy Warnings

Use only if clearly needed

US FDA pregnancy category: C

Animal studies in rat offspring have shown nonteratogenic skeletal deformities consisting of shortening, thickening, and bending of the humerus when dams received 15 times expected clinical exposure of repaglinide on days 17 to 22 of gestation and during lactation. Teratogenicity was not observed in rats or rabbits exposed to doses of 40 times and 0.8 times expected human exposure, respectively, throughout pregnancy. Animal studies with metformin do not indicate harmful effects with respect to pregnancy, embryo or fetal development, birth or postnatal development. There are no controlled data in pregnant women with combination use or use of the individual components. In humans, abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities. Most experts recommend insulin use during pregnancy to maintain blood glucose levels.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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Metformin / repaglinide Breastfeeding Warnings

Use is not recommended

Excreted into human milk: repaglinide (Unknown); metformin (Yes)
Excreted into animal milk: repaglinide (Yes); metformin (Yes)

Comments: Blood glucose should be monitored in the breastfed infant.

Measurable levels of repaglinide have been detected in the breast milk of rats resulting in lowered blood glucose levels in the pups. Metformin drug levels in breastfed infants are expected to be 0.5% of their mother's weight-adjusted dosage. There is no information on combination use of these agents in breastfed infants or its excretion into human milk.

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Further information

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