If men take the diabetes drug metformin three months before conception, there is a 40% higher risk of birth defects in the baby.
The number of people with type 2 diabetes is increasing. The reasons are unhealthy diet, obesity and lack of exercise. And worst of all, those affected are getting younger and younger. The active ingredient metformin is a common medication used to treat type 2 diabetes. It is said to inhibit an enzyme for the formation of glucose in the liver and slow the absorption of sugar from food in the intestine.
Maarten Wensink of the University of Southern Denmark in Odense and his colleagues have now investigated whether metformin and other diabetes drugs also affect male reproduction. The study used national registries to track more than 1 million births between 1997 and 2016 and compared the risk of serious birth defects in babies based on paternal use of diabetes medication. Only children born to women under the age of 35 and conceived by men under the age of 40 were observed in the study. Babies born to women with diabetes were excluded. The researchers considered men exposed to metformin if they prescribed metformin in the three months leading up to conception — the time it takes for sperm to fully mature.
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More malformations in paternal use of metformin
According to the study, the incidence of birth defects was 3.1% (1,594 children) in children born to men diagnosed with type 2 diabetes but not taking metformin, and 4% in children whose parents had taken metformin. 6% (788). Genital birth defects, which occurred only in male infants, were the only birth defect associated with a statistically significant increased risk after paternal metformin use in the study. Men who took metformin before or after the three-month sperm maturation period were not at increased risk of having a child with birth defects. Interestingly, maternal use of insulin, metformin, or sulfonyluric acid did not result in an increased rate of malformations.
However, the study cannot prove a causal relationship. Whether metformin is indeed the cause of the malformation in children cannot be proved on the basis of these data alone. The researchers point to further investigations that are needed.
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Insulin and other diabetes medications
As previous research has shown that diabetes can affect sperm quality and reduce male fertility, the researchers also compared rates of birth defects in babies born to fathers who took insulin with babies born to men who took metformin. Simply to ensure that the diagnosis of diabetes itself did not contribute to the malformation. Here’s how it is: According to scientists, taking insulin was not associated with a change in the rate of malformations. Diabetes medications other than metformin also had no detrimental effect on child development.
However, the authors note that they did not have data on other aspects of diabetes, such as men’s control of blood sugar levels or medication adherence, because they analyzed the data only at the time of prescription filling. In addition, the parents of babies who were treated with metformin by the father were generally older and often took medication for high blood pressure or blood lipid levels in addition to their diabetes medication. This can also play a role. There are currently no warnings from the US Food and Drug Administration (FDA) against the use of metformin by men trying to conceive.
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