SOURCES: Michele Jonsson Funk, Ph.D., assistant professor, epidemiology, University of North Carolina at Chapel Hill; Richard Holt, M.B., Ph.D., professor, diabetes and endocrinology, University of Southampton, England; Jonathan Blau, M.D., associate director, neonatology, Staten Island University Hospital, Staten Island, N.Y.; March 30, 2015, JAMA Pediatrics
MONDAY, March 30, 2015 (HealthDay News) -- When used to treat diabetes that develops during pregnancy (gestational diabetes), the drug glyburide has been linked to a number of complications in the baby, according to a new study.
In fact, infants born to mothers given glyburide (DiaBeta) during pregnancy had a higher risk of respiratory distress, needing intensive care, having low blood sugar, being too large at birth, and birth injury when compared to babies born to mothers treated with insulin.
There has been widespread and rapid uptake in the use of glyburide in mothers with gestational diabetes in the last 10 years, according to the report.
"Doctors and patients need to be aware that although glyburide is easier to use than insulin, not all women may be good candidates for management with this medication," said lead researcher Michele Jonsson Funk, an assistant professor of epidemiology at the University of North Carolina at Chapel Hill. "We need to better understand which women can be treated effectively with glyburide, considering not only the short-term but also the long-term effects that these treatments may have on the health of their newborns," she said.
It's important to note, however, that while this study found an association between the use of glyburide and an increased risk of complications, the study wasn't designed to show a cause-and-effect relationship.
And Funk added that exactly why the drug is linked with these complications isn't clear.
But these findings are especially concerning since, according to Funk, the number of women who develop gestational diabetes in the United States has more than doubled during the last 20 years.
The report was published March 30 in JAMA Pediatrics.
"Glyburide has been used increasingly in pregnancy over the last 10 years. Although the initial trial data suggested it was safe, large studies including this one have raised concerns about the safety of its use," said Dr. Richard Holt, author of an accompanying editorial in the journal, and a professor of diabetes and endocrinology at the University of Southampton in England.
Using a nationwide, employer-based insurance database, Funk and her colleagues collected data on more than 110,000 women with gestational diabetes. Women with type 1 or type 2 diabetes were excluded from this study. The researchers also excluded women under 15 or over 45 years, as well as women pregnant with multiples.
About 8 percent of women with gestational diabetes were treated with glyburide or insulin, according to the study. During the study period -- 2000 to 2011 -- the use of glyburide increased from 8.5 percent to 64 percent, the researchers found.
The study reported a 3 percent difference in the number of babies who needed neonatal intensive care admission, with babies born to mothers on glyburide more likely to end up in the NICU than babies born to mothers taking insulin.
The researchers also found that 1.1 percent more babies of mothers on glyburide had respiratory distress than babies born to mothers on insulin. The difference in the number of babies born too large for their gestational age was 1.4 percent more for babies exposed to glyburide compared to babies exposed to insulin.
The study authors suggested a possible reason for the differences in birth complications may be that women on glyburide don't have adequate control of blood sugar levels.
Holt said more research is needed, and that doctors should "look for alternatives to glyburide until more safety data are available."
Dr. Jonathan Blau, the associate director of neonatology at Staten Island University Hospital in New York City, said, "It is very concerning that a drug that is routinely used to manage gestational diabetes apparently results in adverse outcomes."
These findings should make doctors cautious about using glyburide, said Blau, who was not part of the study. "There is enough evidence from this study that doctors would do well to postpone use of this medication until additional studies are done and instead consider different therapies for gestational diabetes."
For more information on gestational diabetes, visit the American Diabetes Association.