The active ingredient in DiaBeta, Micronase and similar gestational diabetes drugs may increase the risk of complications among newborns when the medications are used by pregnant women, according to the findings of a new study.
Researchers from the University of North Carolina at Chapel Hill and the University of Maryland in Baltimore, found that children born to women given drugs with the active ingredient glyburide during pregnancy were more than 40% more likely to be admitted to the neonatal intensive care unit than the children of women who were not given the drug. The findings were published this week in the medical journal JAMA Pediatrics.
The study involved data on 110,879 women who suffered gestational diabetes mellitus (GDM) as determined by U.S. employer-based insurance claims from January 1, 2000, to December 31, 2011. They found that among those women, 4,82 were treated with glyburide and 4,191 were treated with insulin.
Researchers found that glyburide, compared to insulin, increased the risk of respiratory distress by 63%, hypoglycemia by 40%, birth injury by 35% and there was a 43% increased risk that the child was born larger for his or her gestational age.
“Newborns from privately insured mothers treated with glyburide were more likely to experience adverse outcomes than those from mothers treated with insulin,” the researchers concluded. “Given the widespread use of glyburide, further investigation of these differences in pregnancy outcomes is a public health priority.”
Glyburide, also known as glibenclaimide, is used to treat type 2 diabetes. It belongs to a class of drugs known as sulfonylurea, which increase the amount of insulin released by the pancreas. Drugs using glyburide, including DiaBeta, Micronase, and Glynase, currently have a pregnancy risk rating of category B and Category C, meaning there is no evidence of risk in humans, but that the existence of risks have not yet been ruled out.
The study comes shortly after research published in last month’s issue of the medical journal Obstetrics & Gynecology, which warned that glyburide appeared to cross the placenta to potentially impact a developing fetus.
Researchers in that study found that 79% of the cord blood samples had glyburide levels of less than 10 mg/mL, but 37% of the cord blood samples had levels of the drug that were higher than the levels detected in the mother.
Placenta transport of drugs, where the drug appears to have crossed the placenta to potentially come into contact with a developing fetus, is often the first indicator that a drug may impact the development of an unborn child.