On February 4, 2011, the U.S. Food and Drug Administration (FDA) approved Makena (hydroxyprogesterone caproate), the first drug to reduce the risk of preterm delivery in women with a history of at least one preterm birth (birth before 37 weeks gestation). In the United States, more than half a million babies, or 1 in every 8, are born premature each year. In most cases, preterm birth occurs because the body spontaneously goes into preterm labor. In other instances, a doctor may decide to deliver a baby early because of risks to the mother and/or child. Over the last 25 years, the rate of preterm birth has increased more that 35 percent, however, late preterm births (born between 34 and 36 weeks) account for nearly three-quarters of those births.
History
Makena is chemically the same as Delalutin, which was approved by the FDA in 1956 to treat female hormone disturbances and cancer. However, it was removed from the market in 2000 for reasons unrelated to the safety of the drug.
Since 2003, the American Congress of Obstetrics and Gynecology has recommended that doctors offer progesterone treatments, commonly known as 17P (a synthetic form of a hormone produced during pregnancy), to high risk woman, but health care providers had to order 17P from specialized compounding pharmacies. This created many barriers to obtaining the drug, such as availability and cost.
Makena, however, will be made by a drug company, not in pharmacies. This offers consistency, high quality and control. Makena will be available in specialty pharmacies and access to it through healthcare coverage will be improved.
What are the Benefits?
Prematurity is the leading cause of death among newborns. It also poses serious health risks. Many babies born premature will spend weeks, maybe even months hospitalized in a neonatal intensive care unit (NICU) until the baby is well enough and strong enough to go home. Prematurity can also lead to other lifelong health problems such as, learning disabilities, cerebral palsy, respiratory problems, vision and hearing loss, as well as feeding and digestive issues.
A collective study by the March of Dimes, the National Institutes for Health and the Centers for Disease Control and Prevention, concluded that Makena could prevent nearly 10,000 premature births annually if all eligible woman received the injections
The FDA reviewed the safety and effectiveness in a clinical trial of 463 pregnant women, ages 16 to 43 who were pregnant with a single fetus and a history of preterm birth. Among the women receiving Makena, 37% delivered before 37 weeks versus 55% who did not receive the drug.
Who is a Candidate?
Women who would be eligible to receive Makena injections would include woman who are pregnant with only one child and who had previously delivered a baby before 37 weeks gestation. The drug is not approved for multiple births or for use in women who have delivered prior to 37 weeks without early labor, for example women having emergency c-sections due to baby distress. Women who have had a premature birth should check with their healthcare provider to see if Makena is appropriate for them.
Alan Fleischman, MD, senior vice president and medical director of the March of Dimes says, “for the first time, we have and FDA-approved treatment to offer women who have delivered a baby too soon, giving them hope that their next child will have a better chance at a healthy start in life.”
How is it Administered?
Makena is administered through weekly injections beginning between 16 and 20 weeks and continuing to 37 weeks. Makena cannot be started past 21 weeks of pregnancy.
What are the Side Effects?
The side effects of Makena are mild and can include pain, swelling or itching at the injection site, hives, nausea and diarrhea. Serious side effects are rare. One report was of a blood clot in the lungs and another of an infection at the injection site.
There are no known side effects to the baby.
The FDA approval of Makena is a monumental step in the fight against premature births.
Sources
- Businessweek.com. “FDA Approves First Drug to Prevent Premature Births” (accessed February 10, 2011)
- CDC.gov. “Premature Birth” (accessed February 18, 2011).
- Parenting.com. “FDA Approves Progesterone Injections to Prevent Premature Birth” (accessed February 10, 2011)
- FDA.gov. “FDA Approves Drug to Reduce Risk of Preterm Birth in At-Risk Pregnant Woman” (accessed February 18, 2011)
Kelly Morga - I am a full-time working mom. I discovered the joy of writing when my husband suggested I start writing a blog. So, I created a personal ...
