FDA-approved preterm birth drug has no benefit and may cause harm, study suggests

pharmafile | March 15, 2017 | News story | Research and Development FDA, Makena 

A study by the UT Southwestern Medical Center has found that the synthetic progestogen hormone 17-alpha hydroxyprogesterone caproate (17-OHPC), a commonly prescribed treatment for preventing premature births, has no benefits and may even increase the risk of gestational diabetes.

The drug, sold under the brand name Makena, was granted accelerated review and finally approved by the FDA in 2011 in part due to the findings of a 2003 study which supported its efficacy. The drug was also supported by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine.

The research examined 430 at-risk women treated with 17-OHPC at Parkland Memorial Hospital between 2012 and 2016, comparing the data against the premature birth rate of 5,787 patients at the hospital between 1988 and 2011 who did not take the drug. It was found that among those treated with 17-OHPC, 25% experienced a premature birth, compared to 16.8% in the historical group.

First author and Assistant Professor of Obstetrics and Gynecology at UT Southwestern Dr David Nelson dismissed the findings on the drug’s efficacy as not statistically significant. Additionally, treatment with the drug led to a 13.4% rate of gestational diabetes, compared to 8% in those in the non-drug group.

Despite its influence, the 2003 study drew scrutiny over the validity of its findings. Critics pointed out that the trial’s control group who did not take 17-OHPC showed an unusually high recurrent premature birth rate of 55%.    

Matt Fellows

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