The first-ever drug known to prevent some preterm births won market approval today from the Food and Drug Administration.
“For the first time, we have an 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,” said Alan Fleischman, MD, senior vice president and medical director of the March of Dimes. “Women who already have had a baby born prematurely should check with their health care provider to see if this treatment is appropriate for them. This treatment is not for everyone.”
The FDA approved hydroxyprogesterone caproate injection, commonly known as 17P, which is a synthetic form of a hormone produced during pregnancy. It will be marketed under the brand name Makena™ and given in weekly injections to pregnant women between 16 and 20 weeks gestation and continuing until 37 weeks gestation. The drug is approved for use by women pregnant with one baby and who already have a baby who was born before 37 weeks of pregnancy either because labor began on its own, without drugs or other methods, or because the membranes surrounding the baby ruptured too early.
Prior to today’s approval of Makena™, health care providers ordered prescriptions of 17P from compounding pharmacies; however, many eligible patients faced logistical and financial barriers to access. FDA approval means the drug now will be widely available only in specialty pharmacies and that there will be improved access of the drug through healthcare coverage.
A published study by the March of Dimes, the National Institutes for Health, and the Centers for Disease Control and Prevention, using data from 2002, estimated that if all women eligible for the progesterone injections received them, nearly 10,000 spontaneous premature births might be prevented each year.
I can't tell you what this means to me. I cried for a good 20 minutes after I read this. I mean, I knew about progesterone shots, but this is new, improved, approved, and attainable. This is really the only good option for me. The other options were:
1) Closely monitor the pregnancy. This is a little scary. What happens when I dilate? Bed rest? (Which research shows doesn't help much anyway, apparently.) Or do we just monitor the labor, delivery, and premature baby in the NICU? I'd rather not merely monitor.
2) Do a cerclage (stitching the cervix shut). According to my doctor, this is just as risky as it is successful (although what I've read on-line says otherwise). The procedure is normally performed at the very beginning of the second trimester. If the cerclage causes infection, rupture of membranes, or labor, the baby wouldn't survive. That's ridiculously scary.
Instead, I think I'll take a shot every week for 11-13 weeks.
I really feel, finally, as though there is hope for having a healthy baby. It's an amazing feeling.