New Drug Makena Helps Prevents Premature Births
On February 4th 2011, Makena (hydroxyprogesterone caproate), the first drug to facilitate the prevention of premature births in women who have a history of spontaneous deliveries earlier than 37 gestational weeks, was approved by the Food and Drug Administration (FDA). According to the March of Dimes, an organization dedicated to fighting premature birth, one in every eight babies delivered in the United States is “premature” (born earlier than 37 weeks). By reducing the chance of premature birth, Makena therefore reduces the baby’s risk of suffering birth complications, lifelong disabilities and death. It is because of these types of reproductive clinical trials that new drugs become available.
In the last 25 years, the rate of premature births has increased by 35% in the United States. Deliveries between 34 and 36 gestational weeks account for 75% of such births. Women with a history of premature births are 2.5 times more likely to have a recurrence when compared to women without such a history or risk factors for preterm birth.
Makena is designed for women with singleton pregnancies (carrying one fetus) that have delivered one premature baby in the past and do not have a specific underlying condition which caused the premature labor. Dr. Alan Fleischman, March of Dimes senior vice president and medical director, stated that; “The most common risk factor for preterm birth is recurrence. This is the first approved drug to prevent recurrence… that will dramatically lower the rate for those women.” Makena is not intended for women carrying twins or have medical risk factors for premature birth.
According to the FDA, Makena is chemically identical to Delalutin, a drug approved by the FDA in 1956. Delalutin was used to treat female hormone issues and cancer. Delalutin was withdrawn from the market, claims the FDA, due to economic reasons.
A multi-centered, double-blind, placebo-controlled and randomized clinical trial of 463 women with singleton pregnancies was conducted for the FDA approval of Makena. The women enrolled in the study were ages 16 to 43 and had a documented history of singleton spontaneous births earlier than 37 gestational weeks. 37% of Makena-treated women delivered before 37 weeks compared to 55% of women given the placebo. 7.5% of Makena-treated woman delivered prior to 25 weeks compared to 4.7% of control subjects, and the proportions of Makena-treated women who delivered before 37, 35 and 32 weeks were lower compared to the control group. The drug was given at a weekly-administered dose of 250 mg via intramuscular injection starting between 16 weeks and 20 weeks and 6 days and continuing until 37 gestational weeks or delivery.
A separate study evaluated the development of those babies born to mothers enrolled in the clinical trial. The study found that children ages 2.5 to 5 years achieved identical developmental objectives whether the mother was treated with the placebo or Makena. The FDA is currently conducting a confirmatory study that is expected to be completed in 2018.
Adverse side effects of Makena may include reactions at the injection site, nodule, urticaria, swelling, pruritus, itching, hives, diarrhea or nausea. Makena is intended for women aged 16 or older with singleton pregnancies. Women with the following conditions should not be treated with Makena: blood clotting issues, breast cancer, hormone-sensitive cancers, liver problems or tumors, kidney problems, high blood pressure, diabetes or prediabetes, epilepsy, asthma, heart problems, migraines, depression or allergies to any ingredient in Makena.
Disclaimer: This article represents our best efforts, but is for educational purposes only and should not be considered to be medical advice. It is not meant to replace the advice of the physician who cares for you and your fetus/child. All medical information should be considered to be incomplete without a physical exam, which is not possible without a visit to your doctor. Never attempt to treat yourself without medical supervision from a doctor.