Men taking the widely prescribed diabetes medication metformin need not worry about the risk of birth defects in their future children, according to a new study published on Wednesday. The research, which tracked over 3 million pregnancies in Norway and Taiwan, found no association between metformin use by fathers during the critical three months before conception—the period of sperm development—and the incidence of birth defects.
Metformin, an affordable and commonly used medication for managing Type 2 diabetes, has long been a first-line treatment for the condition. However, past studies, including a 2022 report from Denmark, had raised concerns by suggesting a potential 1.4-fold increase in the risk of birth defects in boys whose fathers had taken metformin.
Despite these early findings, subsequent research has not confirmed any such association. A pair of studies published in the Annals of Internal Medicine last June provided further reassurance, indicating that neither maternal nor paternal metformin use raised the risk of congenital malformations.
This latest, large-scale analysis strengthens the reassuring message, using data from two diverse populations—Norway and Taiwan. Dr. Allan Pacey, a leading expert in male reproductive health from the University of Manchester in the UK, who was not involved in the study, commented on the significance of the findings.
“The new data clearly supports the notion that metformin use in men does not contribute to birth defects,” Dr. Pacey explained. “There was never any plausible biological mechanism that would explain such a link, and this new study, with its higher quality data, reflects that.”
The comprehensive study included a wide array of confounding factors, providing a clearer and more complete picture than previous research, Dr. Pacey noted. The use of such robust data from two countries with different healthcare systems lends further credibility to the findings.
This groundbreaking study, published in The BMJ, offers men with Type 2 diabetes peace of mind, confirming that they can safely use metformin when planning to start a family without risking their children’s health.
As Type 2 diabetes affects millions of men worldwide, these findings are an important step forward in ensuring safe, evidence-based healthcare decisions for those looking to father healthy children.
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