(Health Korea News / Lee Chung-man) The diabetes drug ‘metformin’, which required caution when taken due to the risk of causing birth defects, appears to have been cleared of wrongdoing.
The British Medical Journal (BMJ) published research results on the 16th (local time) showing that taking metformin in men does not cause congenital deformities in the fetus. The study was conducted in collaboration between the Norwegian Research Council and Taiwan’s National Science and Technology Council.
The story begins in March 2022. According to a study conducted by researchers at Stanford University School of Medicine in the United States and Denmark, it was found that if a man takes metformin within 3 months of a woman’s pregnancy, the risk of congenital deformities in the boy increases.
For reference, male sperm mature in a cycle of approximately 64 to 74 days. Therefore, if you are planning a pregnancy, it is important to take care of your health during the three months before pregnancy.
The researchers analyzed a database of more than 1 million people based on the Danish government’s health registry data. The results showed that the incidence of genital defects increased by about 40% only in boys, depending on whether metformin was used during sperm maturation.
At the time, researchers were unable to clearly determine why this happened. Accordingly, rumors were floating around that ‘metformin’ lowers testosterone levels and potentially reduces sperm quality.
Additionally, this conclusion gave rise to numerous controversies at the time. This is because ‘metformin’ is one of the currently widely used treatments for type 2 diabetes.
This drug prevents the production of glucose in the liver and reduces the absorption of glucose in the intestines, thereby improving sensitivity to insulin. The original is ‘Glucophage’ from Germany’s Merck, which was approved by the U.S. Food and Drug Administration (FDA) in March 1995.
The international academic journal Nature reported in May 2023 that more than 200 million people worldwide take ‘metformin’ every day.
In Korea, it is widely used as an ingredient in chronic disease complex drugs. The number of metformin preparation items approved by the Ministry of Food and Drug Safety reaches 1,574 as of the 17th.
Meanwhile, when research results showed that ‘metformin’ causes birth defects, researchers around the world began research to determine the relationship between ‘metformin’ and causing birth defects.
Since then, small-scale research results have appeared one after another, refuting this conclusion. The paper published this time in BMJ is the result of research based on a large-scale analysis database, and appears to be driving a wedge of refutation.
The research team analyzed data from approximately 620,000 fetuses born in Norway between 2010 and 2021 and more than 2.5 million fetuses born in Taiwan between 2004 and 2018. As a result, it was found that there was no correlation between the father’s use of metformin and the fetus’s malformation.
In a study conducted in Norway on fathers of 620,000 fetuses, the birth defect rates depending on whether or not they took metformin were 5% and 4%, respectively, which was not statistically significant. Similarly, in the Taiwan analysis, the incidence of birth defects was 3%.
Even when the research team controlled for other variables, the risk of fetal birth defects associated with metformin did not increase at all.
In this regard, an expert said, “This study will not completely resolve the concerns raised by the Danish researchers, and additional confirmatory studies will be needed,” but added, “At least, these results will ease the concerns of expectant fathers so that they can take ‘metformin’ with confidence.” “I will give it to you,” he said.
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