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Diabetes: no link between metformin and birth defects, according to a large study

Metformin, a commonly prescribed antidiabetic drug, does not put men who take it at risk of having children with congenital malformations, according to a study published Thursday by the BMJ.

A recent Danish study reported a possible link between taking this very common antidiabetic drug in men of childbearing age and an increased risk of malformations, particularly genital malformations, in their male infants.

This study led health authorities in the United Kingdom, where there were 24 million prescriptions for this drug in 2022-23, to warn future fathers, recognizing the possible risks associated with taking metformin and the need additional research.

However, the causal link between taking this antidiabetic drug by a future father before conception and the risk of seeing his child affected by congenital malformations has not been established.

To provide some answers, researchers examined more than three million births registered in national registers as well as prescription databases in Norway and Taiwan, reports the BMJ.

They thus identified 619,389 Norwegian children for whom data existed on the period of development of their father’s sperm — the three months preceding conception — from 2010 to 2021, and 2,563,812 Taiwanese children, from 2004 to 2018. The Fathers of 2,075 (0.3%) children born in Norway and 15,276 (0.6%) children born in Taiwan had taken metformin.

In Norway, birth defects were found in 24,041 (3.9%) children whose fathers were not taking this medicine, compared to 104 (5%) children whose fathers were taking the drug.

Similarly, in Taiwan, birth defects were noted in 79,278 (3.1%) children of fathers not taking metformin, compared to 512 (3.4%) children whose fathers were taking it.

But, after limiting the analyzes to fathers with type 2 diabetes and correcting the results for other important factors such as the father’s age, no increased risk of malformations was observed, neither in Norway nor in Taiwan.

“These results are reassuring and may help doctors make informed treatment decisions when choosing metformin for the treatment of type 2 diabetes in men planning to start a family,” concludes the BMJ.

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