New Drug Helps Halt Preterm Labor

 The U.S. Food and Drug Administration (FDA) recently approved a new drug called Makena® (hydroxyprogesterone caproate) to help prevent premature birth in women before 37 weeks gestation, who have had at least one previous preterm delivery.
Preterm birth, defined as birth before 37 weeks gestation, is a major public health priority. According to the March of Dimes, preterm birth affects one in eight babies born in the United States, and these infants face the risk of developing a wide variety of physical and neurologic disabilities, including intellectual and developmental disabilities, cerebral palsy, and visual impairment. These infants are also at high risk for long-term health issues, including cardiovascular disease and diabetes.

Makena® is approved for use in the U.S. under certain conditions. The patient must have a singleton (single fetus) pregnancy, at risk for preterm birth, and has previously given birth prematurely to one baby. According to the FDA, the drug is not intended to be used by women having twins or other risk factors for preterm birth. Since the most common risk factor for preterm birth is recurrence, the approval of this drug is a major breakthrough in the prevention of premature deliveries in high risk groups.

However, the new wonder drug is not without some controversy. In 2006, an FDA advisory committee identified some potential safety concerns with the use of hydroxyprogesterone caproate, including a possible association with second trimester miscarriages. Hydroxyprogesterone caproate is also the active ingredient in Delalutin®, an older drug approved by the FDA in 1956, to treat female hormone disturbances and cancer. This drug was withdrawn from the market for reasons unrelated to safety in 2008.

Although Makena® is chemically the same as Delalutin®, the quality and consistency of the drug will be better regulated, as the drug will be manufactured by the drug company itself, and not by individual pharmacies.

The FDA has reviewed data on the safety and effectiveness of Makena® from a recent clinical trial that included 463 pregnant women who had a history of a spontaneous preterm birth. Among those receiving Makena®, 37 percent delivered before 37 weeks, compared with 55 percent of women who did not get the drug. Another study evaluated the development of children born to mothers enrolled in the first trial. It was found that the children in the study reached the same developmental targets, whether or not the mother was given the drug. The study is ongoing and will be followed by a similar infant follow-up study, to be completed in 2018.

Makena® is given by injection once a week from the 16th to the 37th week of pregnancy, by injection into the hip. The drug is being marketed by St. Louis-based KV Pharmaceutical.

According to the FDA, the most common side effects reported with Makena® included pain, swelling, or itching at the injection site; hives, nausea and diarrhea. Serious adverse reactions are rare.