In recent years physicians have increasingly used the medication glyburide for gestational diabetes. This off-label use of glyburide by physicians is most likely due to the fact that it is much easier for patients to take a glyburide pill than it is to use a syringe to inject themselves with insulin. However, insulin is the only medication approved for the treatment of gestational diabetes mellitus by the FDA and endorsed by the American Diabetes Association.

Prior to March of 2015 only a few small clinical trials and observational studies existed for this off-label use of glyburide. It appears that clinical off-label use of glyburide moved ahead of the science to support its use. However, in the March 30, 2015 edition of JAMA Pediatrics, the results of a much larger study were published. The size of the JAMA study allowed for a more detailed analysis of the differences in outcomes and a more precise analysis of those differences.

According to the JAMA study, newborns of women who are treated with glyburide for gestational diabetes are at an increased risk for admission to the neonatal intensive care unit, respiratory distress, hypoglycemia, birth injury, and large for gestational age status, when compared with newborns of women treated with insulin. The increase in risk to due to the use of glyburide is striking. You can view an abstract of the study here:

[Association of Adverse Pregnancy Outcomes With Glyburide vs Insulin in Women With Gestational Diabetes](http://archpedi.jamanetwork.com/article.aspx?articleid=2211139)

Infants of women treated with glyburide had a 41% higher risk for NICU admission, a 63% higher risk of respiratory distress, a 40% higher risk of hypoglycemia, and a 35% higher risk of birth injury, compared with infants born to women treated with insulin. These findings, together with those of previous limited studies, present a significant cause for concern for the continued use of this off-label of this medication for treatment of gestational diabetes.

While it is unlikely that publication of the JAMA study alone will cause physicians to stop using glyburide to treat gestational diabetes, the standard of care may change in the future. More research is likely needed. However, the study does demonstrate that using glyburide for management of gestational diabetes creates a significant risk of harm to the infant, and the only benefit is the fact it is orally administered. At a minimum, the JAMA study’s results should cause physicians to carefully weigh the risks and benefits of off-label use of glyburide for management of gestational diabetes.