A drug that is used by pregnant women to prevent preterm birth may not only not be effective, but may increase the risk of a serious side effect, gestational diabetes.
The drug, Makena, is a synthetic progesterone known as 17-alpha hydroxyprogesterone caproate. It was approved by the FDA in 2011 to treat women at risk of delivering a second premature baby. The drug received accelerated approval in large part to a 2003 study published in the new England Journal of Medicine.
Makena is also endorsed American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine. However, the drug has been plagued by controversy due to its relatively high price tag and questions surrounding the 2003 study.
In the new study, researchers offered the drug to women if they had a history of premature births and were carrying a single fetus. The study followed a total of 430 women who took the drug at a Texas hospital. Those results were compared with the premature birth rate of 5,787 women at the same hospital who had a history of premature delivery but didn’t take the drug.
Premature birth occurred in 25% of the women that took Makena, compared to a 16.8% in women who never took the drug, researchers reported in the American Journal of Obstetrics and Gynecology. And the rate of gestational diabetes was 13.4% in women treated with Makena, compared with 8% in the historical group.
While gestational diabetes often goes away after birth, it can lead to the delivery of larger babies and higher chances for cesarean sections and other birth complications.
Jonathan Block is MedShadow’s content editor. He has previously worked for Psychiatry Advisor, Modern Healthcare, Health Reform Week and The Pink Sheet.