FDA Approves Drug That Can Prevent Premature Birth


It can only be used on women who have had one previous premature birth. It’s called Makena (hydroxyprogesterone caproate). It’s given as a weekly injection starting at week 16 and continued through to 37 weeks.  It is expected to reduce the risk of premature delivery, which is associated with a range of problems depending on how prematurely the baby is born.

According to the March of Dimes, one in eight babies is born prematurely. Term is considered anywhere between 37 and 42 weeks– 40 weeks is given as the estimated due date. Babies born between 34 and 36 weeks account for nearly 75% of pre-term births. The FDA claims this drug can reduce the number of babies born before 37 weeks in women who have already had one preterm birth. “The most common risk factor for preterm birth is recurrence,” said Dr. Alan Fleischman, of the March of Dimes. “This is the first approved drug to prevent recurrence for women who have had a singleton preterm baby and now have a singleton baby,” he added. “That will dramatically [lower the] rate for those women.”

Makena is a synthetic form of a hormone produced during pregnancy, known as 17P. It’s been used for a while but was only just approved by the FDA. It was put it on a fast-track approval schedule. Evidence used to support the approval of the drug included one  clinical trial involving 463 pregnant women with histories of pre-term births. The results showed that 37% of the women who used Makena delivered before 37 weeks, where as 55% of women not on the drug delivered before 37 weeks.

According to the FDA, there are some common side effects including pain, swelling or itching at the injection site;  nausea, diarrhea and hives. Serious adverse reactions are rare though there was a report of a blood clot and an infection at the site of injection, the agency said.