Words by GOLD newsdesk
The first oral anti-diabetic medication to be used safely by pregnant women from conception to birth has been approved by a European Worksharing Procedure (WSP).
Merck’s metformin product Glucophage has received a label extension for use throughout pregnancy in women with diabetes after positive results from the company’s register-based safety cohort study CLUE.
The study investigated outcomes from approximately 4,000 pregnancies with metformin, following up with the children for up to 11 years, and confirmed no increased risk of congenital abnormalities or fetal/neonatal toxicity after exposure to metformin at the time of conception and throughout pregnancy. Extensive independent scientific publications reflected the same findings.
“During pregnancy and when wanting to become pregnant, good glycaemic control is of utmost importance, as insufficient glycaemic control leads to a three times higher risk of pregnancy loss than in normoglycemic women. The estimated risk of malformation is doubled,” said Maria Rivas, SVP and Chief Medical Officer, Merck. “Until now, pregnant women were required to use insulin to control their blood sugar during this period. The label extension now opens a tablet alternative to women who are not able or wanting to use daily injections.”
In 2021, 21.1 million births worldwide (16.7%) were affected by hyperglycaemia, and the prevalence of hyperglycaemia during pregnancy is rising. In Europe, it is estimated 3-7% of all pregnant women develop gestational diabetes.