Some studies have raised concerns about a possible link between the widely used type 2 diabetes drug, metformin , and an increased risk of conceiving a baby with birth defects. However, new research now suggests that use of the medication among men planning to conceive or women early in pregnancy does not appear to be associated with an increased risk of serious birth defects in their children.
The two studies, published on Monday (17) in the Annals of Internal Medicine, contradict a 2022 study that linked the use of metformin by men in the three months before conceiving a baby to a 40% increase in the risk of birth defects. congenital in their descendants.
The results provide “peace of mind” for parents, according to Ran Rotem, author of the new study on paternal metformin use and researcher at the Harvard TH Chan School of Public Health.
“Conventionally and traditionally, the focus has been on the mother when it comes to pregnancy and fetal and newborn health. What we are finding more and more is that the father is important too,” she says.
He added that the increased risk of birth defects seen in previous research may be associated with the diabetes disease itself or related comorbidities, rather than the medication itself.
“When we think about a medication, we also need to consider the underlying conditions for which the medication is typically prescribed,” says Rotem. “We know that diabetes itself is complicated when it comes to both fertility and potential complications in pregnancy and newborns.”
Metformin is a first-line medication for treating type 2 diabetes and has been widely used to help control blood sugar levels since the 1960s.
The drug is currently the most commonly prescribed for type 2 diabetes, and before taking metformin, it is recommended that people tell their doctor if they plan to become pregnant, are pregnant or are breastfeeding.
“The father’s health seems to be important”
For the study on paternal use of metforminresearchers from the Harvard TH Chan School of Public Health and the Kahn-Sagol-Maccabi Research and Innovation Center at Maccabi Healthcare Services in Israel, analyzed data from birth records and medical records of almost 400,000 babies born in Israel between 1999 and 2020 .
They compared this data with information about the babies’ parents, such as their ages, laboratory test results and medication records, including data on metformin prescriptions.
Although the researchers didn’t look specifically at how long the men had been taking the medication, “we had a lot of people who had been taking the medication for a long time, and the results were pretty consistent for those individuals as well,” says Rotem.
The researchers found that the prevalence of major birth defects was 4.7% in children of parents not exposed to diabetes medications in the months before conception, compared with 6.2% in children of parents exposed to metformin before conception.
When the researchers adjusted the data for factors such as the parents’ other underlying health conditions and whether the mother also had diabetes or related comorbidities, they found no increased risk of major birth defects in children exposed to paternal metformin.
Men who used diabetes medications during the sperm development period before conception tended to be older, had a higher prevalence of underlying health conditions, and were more likely to have fertility problems and a history of smoking compared to with parents who were not exposed to diabetes medications.
“We found that paternal use of metformin during the period of sperm development is not associated with an excess risk of malformations in newborns, providing reassurance that fathers planning to start a family can continue using the medication to control their diabetes,” Rotem said. “More broadly, our study also suggests that maintaining a good cardiometabolic health profile is important for both partners.”
A higher prevalence of underlying health conditions, as well as fertility problems, was also observed among mothers of children whose parents used metformin, compared with mothers of children whose parents were not exposed to diabetes medications.
“If the father is using diabetes medications, it is much more likely that the mother is also using diabetes medications or has other metabolic comorbidities,” says Rotem.
“We know that diabetes itself is not good when it is present in the mother, and we are finding evidence that it is difficult for the fathers too,” he says. “If you can control diabetes just by changing your lifestyle – getting more exercise, watching your diet – that’s probably good and helpful anyway. But if you need to be medicated, it appears that metformin is a safe choice for both.”
The data also showed that the risk of birth defects was higher when the father used metformin along with other medications, described as polytherapy. Paternal use of metformin alone, known as monotherapy, did not appear to increase the risk of birth defects.
“When we looked at specific treatment regimens, modestly elevated risks were still observed, specifically among children of parents who used metformin in conjunction with some other diabetes medication,” explains Rotem.
“But we also observed that parents who took several medications had less well-controlled diabetes,” he says. “This again indicates that the modestly elevated risk observed for diabetes polytherapies was likely not caused by the medications themselves, but rather by the poorer cardiometabolic health profile of the parents.”
“Inadequate blood sugar control is a risk factor”
The other study published on Monday (17) in Annals of Internal Medicine had similar findings for mothers. Women who continued using metformin and added insulin as a treatment in the first trimester of pregnancy showed little or no increase in the risk of giving birth to a baby with major birth defects compared with women who stopped metformin and switched to insulin, the study found.
The researchers, also from the Harvard TH Chan School of Public Health, studied data from more than 12,000 women with type 2 diabetes and their pregnancies. Data came from the US Medicaid Health Administration database from 2000 to 2018.
The analysis showed that the estimated risk of giving birth to a baby with birth defects was about 6% when the mother received insulin plus metformin, compared with 8% when the mother received insulin alone.
“We were not surprised by our findings. Although metformin can cross the placenta, potentially affecting the fetus, metformin may help with blood sugar control, which may reduce the risk of birth defects,” explains Yu-Han Chiu, lead author of the study and researcher at Harvard T.H. Chan School of Public Health and Penn State College of Medicine, in email.
“Improper blood sugar control is a risk factor for birth defects. Insulin in combination with metformin may result in better blood sugar control than using insulin alone. This may explain why we observed a slightly lower risk of birth with congenital malformations compared to using insulin alone,” says Chiu.
“For women with type 2 diabetes who are taking metformin and plan to conceive, our study suggests that continuing metformin has no or little increased risk of birth defects compared with switching to insulin.”
A “complex picture”
The two new studies are “well done,” says Meleen Chuang, medical director of women’s health at NYU Langone Centers for Family Health, in an email.
“I wouldn’t change the way metformin is prescribed for parents who are trying to conceive,” says Chuang, who was not involved in the new studies and serves as chief of obstetrics and gynecology at NYU Langone Brooklyn.
“I would encourage weight loss, diet and exercise as part of preconception care for both parents,” he adds. “Reducing modifiable risk factors, such as losing weight, stopping smoking, alcohol and substance use, are some ways to improve health and fertility.”
The possible risks that can come with paternal and maternal metformin use remain a “complex picture,” but the new studies help make this evolving picture clearer, wrote Sarah Martins da Silva of the University of Dundee in the United Kingdom in one editorial published alongside the two studies on Monday.
“Clearly, individual risks and benefits must be carefully considered and results must be interpreted with caution, as studies lack information on glycemic control,” she wrote.
“However, these recent analyzes suggest that metformin is a safe and effective treatment option for [diabetes tipo 2] for men and women trying to conceive, as well as for the management of hyperglycemia in pregnant women in the first trimester,” he added, “and it may be time to reconsider current prenatal care guidelines that advocate switching to insulin therapy. ”
Study reveals action of most used medication for type 2 diabetes
Source: CNN Brasil
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