Controversy on Drug Used in Preventing Pre-Term Births

Premature birth during pregnancy is a compelling health concern in the U.S.A.  In 2011, the FDA approved 17-alpha hydroxyprogesterone caproate (Makena) to decrease the hazard of untimely childbirth of single-fetus within 37 weeks of conception in gestating women with a past history of one or more impulsive premature single fetus delivery.  Considering Makena’s prospect to expect a clinical advantage, the inventor of the drugmaker had to execute further analysis post approval (Phase 4 study) to prove that Makena has a clinical advantage. Critics of Makena point to studies  which show that the drug presents no clinical advantage, predisposes the drug users to a higher rate of pregnancy-induced diabetes, and also criticize the high cost of the drug.

There were 430 subjects who qualified for the study of Makena from 2012 to 2016.  In comparison to 5,787 women who did not take Makena and had recorded premature fetus births between 1988 and 2011, there was 0.25 premature fetus delivery in the pregnant women (with single fetus) who took the drug from 2012 to 2016 and 0.17 premature fetus delivery in the pregnant women (with single fetus) who did not take the drug from 1988 to 2011.  “According to Dr. Nelson, a Dedman Family Scholar in Clinical Care, the differences between the two outcomes are not statistically significant”.

 In addition, there was evidence of higher pregnancy induced diabetes in the same subjects who took Makena from 2012 to 2016.  Further testing of the same women used for the same study shows pregnancy induced diabetes in the pregnant women who took Makena from 2012 to 2016 occurred in 13% of the cases in comparison with 8% results from pregnant women who did not take Makena from 1988 to 2011. Pregnancy induced diabetes generally disappears after delivery, but it could cause obesity in newborns and a higher possibility for C-section and other childbearing problems.

Furthermore, there are grievances about the high cost of Makena.  Prior to its FDA approval, the Pharmaceutical Company (KV) that marketed Makena was charging between $10 to $25 for its once per week dosage.  A few days after Makena’s FDA endorsement, KV broadcasted that the cost of the drug would be $1,500 for its once per week dosage (“Science Daily,” 2017).  The new cost caused alarming protests in the drug industry and by its users.  In reaction to this, the FDA dropped KV’s application for licensed selling of Makena and allowed compounding pharmacies to keep producing and selling generic Makena.

Adebimpe Koyi, BS, MBA is a CRA Academy Alumni.