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Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with increased risk of congenital abnormalities and perinatal mortality. It is important to maintain blood glucose levels as close to normal as possible throughout pregnancy, to reduce the risk of adverse hyperglycaemia outcomes to the mother and her child.
Metformin crosses the placenta with levels that can be as high as maternal concentrations.
A large amount of data on pregnant women (more than 1000 exposed outcomes) from a register-based cohort study and published data (meta-analyses, clinical studies, and registries), indicates no increased risk of congenital abnormalities nor feto/neonatal toxicity after exposure to metformin in the periconceptional phase and/or during pregnancy.
There is limited and inconclusive evidence on the metformin effect on long-term weight outcome of children exposed in utero. Metformin does not appear to affect motor and social development upto 4 years of age in children exposed during pregnancy although data on long term outcomes are limited.
If clinically needed, the use of metformin can be considered during the pregnancy and in the periconceptional phase as an additionally or an alternative to insulin.
Breast-feeding: Metformin is excreted into human breast milk. No adverse effects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breast-feeding should be made, taking into account the benefit of breast-feeding and the potential risk to adverse effect on the child.
Fertility: Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/kg/day, which is approximately three times the maximum recommended human daily dose based on body surface area comparisons.
