Rhea Metformin Hydrochloride Use In Pregnancy & Lactation

Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with increased risk of congenital abnormalities and perinatal mortality.
A limited amount of data from the use of metformin in pregnant women does not indicate an increased risk of congenital abnormalities. Animal studies do not indicate harmful effects with respect to pregnancy, embryonic or fetal development, parturition or postnatal development (see Pharmacology: Toxicology: Preclinical and Safety Data under Actions). However, when the patient plans to become pregnant and during pregnancy, it is recommended that diabetes is not treated with metformin but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce risk of malformations of the fetus.
Metformin is excreted into human breast milk. No adverse effects were observed in breastfed newborn/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breastfeeding should be made, taking into account the benefit of breastfeeding and potential risk to adverse effects on the child.