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Drug’s Safety Questioned for Gestational Diabetes

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Newborns of mothers who took glyburide to treat gestational diabetes mellitus needed neonatal intensive care more often than infants whose mothers were on insulin therapy for gestational diabetes, according to a study published in JAMA Pediatrics. While the report has not yet triggered an FDA inquiry into whether the medication should be contraindicated in pregnancy, researchers recommended further study into the matter.

The researchers found that newborns of women with gestational diabetes who used glyburide had an increased risk of respiratory distress, hypoglycemia, and being large for gestational age. Glyburide therapy to treat gestational diabetes is considered an “off-label” use, meaning that its use is not specifically covered in the FDA’s stated market clearance for the drug.

In pregnancy, the placenta produces a combination of hormones which can actually suppress the effectiveness of insulin, leading to elevated glucose levels, and this process accelerates as the baby develops in utero. Women who have Type 2 diabetes before pregnancy often need to either start insulin therapy or use oral medication like metformin or glyburide to boost their bodies’ insulin production. Women with Type 1 diabetes often must adjust their insulin regimen during pregnancy, as well. According to diagnostic criteria, women who have gestational diabetes are not diabetic before becoming pregnant. Usually, gestational diabetes is treated with a low-carb diet and weight control. Oral medication to combat blood glucose buildup can be prescribed, but insulin therapy is becoming an increasingly popular option.

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Jim Cahill is a former staff writer for Insulin Nation and a former editor of Type 2 nation.

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