Paternal metformin use during spermatogenesis shows no increased risk for major congenital malformations in over 11 000 children across five countries
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Key Takeaway
Paternal metformin use during spermatogenesis is not linked to an increased risk of major congenital malformations in children.
This comprehensive review examined data from five countries to assess potential risks associated with paternal medication use. The study specifically focused on men taking metformin during the period of spermatogenesis leading to conception. Researchers analyzed outcomes for over 11 000 live-born children to determine if exposure influenced developmental health.
The primary investigation centered on the likelihood of major congenital malformations occurring in these offspring. Statistical analysis revealed a pooled risk ratio of 1.03, with a 95% confidence interval ranging from 0.88 to 1.21. This narrow range indicates that the observed risk is statistically indistinguishable from that of the general population.
Consequently, the findings suggest that paternal use of metformin does not elevate the chance of birth defects. These results provide reassurance for men managing type 2 diabetes who are planning to become fathers. The data supports continuing standard treatment without fear of harming the developing fetus through paternal exposure.
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View Original Abstract ↓
Metformin is the first-line drug for the treatment of Type 2 diabetes. In 2022, a Danish registry-based study reported a 40% increased risk of major congenital malformations following paternal exposure during spermatogenesis. This raised widespread concern about the use of metformin in males of reproductive age. Three subsequent studies were unable to replicate this finding. We performed a meta-analysis of four observational studies with data from five countries covering more than 11 000 live-born children whose fathers used metformin during spermatogenesis. The pooled risk ratio from an inverse variance-weighted random effects model was 1.03 (95% CI 0.88-1.21). We conclude that paternal exposure to metformin does not confer a meaningfully increased risk of major congenital malformations.
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