Glucovance Use In Pregnancy & Lactation

Pregnancy: Risk related to diabetes: When uncontrolled, diabetes (gestational or permanent) gives rise to an increase in congenital abnormalities and perinatal mortality. Diabetes must be controlled as far as possible during the period of conception in order to reduce the risk of congenital abnormalities.
Risk related to metformin: Studies in animals have shown no evidence of teratogenic activity. In the absence of a teratogenic effect in animals, fetal malformation in humans is not to be expected since to date, substances known to cause malformation in humans have proved to be teratogenic in well-conducted animal studies in two species.
Clinical studies involving a few small series have not shown evidence of fetal malformation directly related to metformin.
Risk related to glibenclamide: Studies in animals have shown no evidence of teratogenic activity. In the absence of a teratogenic effect in animals, fetal malformation in humans is not to be expected since to date, substances known to cause malformation in humans have proved to be teratogenic in well-conducted animal studies in two species.
In clinical practice, there are currently no relevant data on which to base an evaluation of potential malformation or fetotoxicity due to glibenclamide when administered during pregnancy.
Management: Adequate blood glucose control allows pregnancy to proceed normally in this category of patients. Metformin + glibenclamide (Glucovance) must not be used for the treatment of diabetes during pregnancy.
It is imperative that insulin be used to achieve adequate blood glucose control. It is recommended that the patient be transferred from oral antidiabetic therapy to insulin as soon as she plans to become pregnant or if pregnancy is exposed to this medicinal product. Neonatal blood glucose monitoring is recommended.
Lactation: Metformin is excreted in milk in lactating rats.
Metformin is excreted into human breast milk in very small amounts. No adverse effects were observed in breastfed newborns/infants. Although it is not known whether glibenclamide is excreted in human milk, some sulphonylureas are excreted in human milk. Because the risk of neonatal hypoglycemia may exist, metformin + glibenclamide (Glucovance) is contraindicated in the event of breastfeeding.