17P is approved by FDA

Update:  The company providing this drug plans to make a huge profit, charging 14,900 % of what it cost previously through compounding pharmacies.  There is no justification for this besides gouging and taking advantage of people who need it the most.  We cannot support March of Dimes due to their conflict of interest because they have received a lot of funding from the company KV  Pharmaceuticals.  They are clearly not putting people ahead of money.

FDA approval of 17P (March of Dimes - News Moms Need)

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.

This makes the treatment much more accessible and we hope that private production doesn't mean it will be expensive.  Something that can prevent any preterm births will save millions of health care dollars.

An update:  It appears that the manufacturers intend to charge an exorbitant amount for Makena which, when compounded, was costing about $10 a dose so even those without insurance or medicaid could afford it.  Now, even though the drug safety has already been determined and the company does not have to do all those expensive studies, they still plan to take advantage of the people and contribute to exploding health care costs.  Stay tuned...


Update 3/31/11:  Check out the FDA taking a stand against the high pricing and letting the compounding pharmacies know they can continue to produce this drug as previously (read low-cost).  Yay, FDA!  Read here.

17 P Screening Statement for Pregnant Women

Have you had a baby born too early or too little?  There is a drug called 17-P that may lessen your chance of having this happen again.  17-P needs to be started between the fourth and sixth months of your pregnancy.  Call your doctor now to see if you should take 17-P (Alpha Hydroxyprogesterone Caproate). 

It is not indicated in all cases, but the best thing to do is ask if it might be the answer for you.

The exact mechanism by which progesterone prevents preterm birth is unknown although it is has been shown to decrease inflammation and blocks the effect of oxytocin on the myometrium, keeping the uterus from contracting. Studies to date have demonstrated that hydroxyprogesterone is not associated with congenital anomalies or other neonatal developmental problems.
An important feature of both recently reported studies is that enrollment was limited to singleton gestations in patients with a previous history of spontaneous preterm delivery. Studies to date have indicated that progesterone is not effective in preventing premature delivery in pregnancies at low risk for prematurity, multiple gestation, or in patients once preterm contractions have occurred.
Current candidates for progesterone should meet the following criteria:

• Singleton pregnancy
• Previous spontaneous preterm delivery (< 37 weeks gestation) of a single baby
  

A preferred use of progesterone is weekly intramuscular injections of 250 mg of 17-P starting at 16 weeks gestation and continuing to 36 weeks and 6 days.  (source)

Prematurity Reduction - New Treatment

17-P Awareness and Utilization

"Delivery of infants prior to 37 completed weeks of gestation is a growing problem not only in the United States as a whole but also in Utah. Approximately one half million babies - or one out of every eight, are born prematurely each year in this country. The rate has risen more than 36% since the early 1980s...

An opportunity to reduce preterm births among women with a history of preterm births is now available through the use of 17 alpha hydroxyprogesterone caproate (17-P).... According to ACOG, women who have had at least one previous preterm birth of a singleton pregnancy due to spontaneous preterm labor or premature rupture of membranes and who are now pregnant with a single fetus are potential candidates for treatment with 17-P. Evidence does not support routine use of progesterone in women with multiple gestations.

...17-P is given by weekly intramuscular injections... Studies indicate that 17-P is most effective if given starting between 16 and 20 weeks gestation and continuing through week 36. Some women identified after 20 weeks gestation may also be candidates."

If this sounds like you, talk to your doctor about this treatment.

(Source: Debby Carapezza, RN, MSN, Nurse Consultant with the Maternal Infant Health Program at the Utah Department of Health, published by the Utah Section Newsletter of the American College of Obstetricians and Gynecologists, Fall, 2009)