FDA approval of 17P

17p-injectionThe 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.

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50 Responses to “FDA approval of 17P”

  1. Julie Says:

    Where is all the information about the side effects. From what I’ve read, there is no way I would take this. I had my son (first child) at 26 weeks and the risks of the injections seems too high to me.

    Is there a full, unbiased report on the actual specifics of clinical use?

  2. Laura Says:

    I am a Neonatal Intensive care nurse and also have an NICU nurse friend who had her first child @ 27 weeks. The reason for her premature labor was unknown and took the progesterone shots with her 2nd and 3rd pregnancies with NO issues. She would do again.

  3. Sarah Says:

    I am currently 22 weeks pregnant with my 3rd son (#2 was born at 33) and I have not had any side effects aside from pain at the injection site and mood swings (which may just be pregnancy related anyway :-)) After having one NICU baby, these side effects are well worth it if I can avoid having another preterm baby.

  4. Elizabeth Says:

    My thoughts exactly! We had our son at 28 weeks and the thought of a weekly injection seems redundant. NEED MORE SIDE EFFECT INFO!!

  5. Cora Says:

    I have been taking the 17P injections both my last pregnancy and this pregnancy. It is a very thick substance which hurts like heck going in and may continue to “burn” for a few hours afterwards but I have had no side effects whatsoever. My doctors and I both agree that the benefits would outweigh any side effects that there may be. My son was born at 28 weeks due to PTL and I think the reason I am still pregnant today is because of the 17P injections.

    Also I am sure that since the FDA approved it, that they have looked at any side effects that it may cause and would not have approved it had there been any serious side effects. I have known many women who take this injection and do not/have not had any side effects and wouldn’t have had healthy full-term babies.

  6. christy Says:

    I took 17P in 2006 with awesome success and little to no side effects. In my opinion, anything that helps my baby grow and develop in my womb rather than in incubator is a welcome pain in the butt (literally -lol!). Thanks to 17p my second child was delivered at 38 weeks so I have nothing but praise for this medical advance!!

  7. Britany Says:

    I received these injections from 21 weeks through 36 weeks and just delivered my twins at 36 weeks 3 days. I never had any contractions and was also on bed rest due to a possible incompetent cervix. In my opinion, these shots helped keep my boys stay put for a long time. I would definitely do it again.

  8. swc Says:

    I just had a 37-1/2 weeker in December thanks to 17p and a cerclage. It was sure worth the 20 weeks of injections and the little discomfort (not nearly as bad as I expected) to have him stay in 10 weeks longer than his 27 week sister. Woohoo FDA, thanks for approving this (too bad you didn’t do it sooner). Now hopefully insurance companies will help cover the costs for those who would benefit from the 17p. I had to pay for 20 shots 100%, but it was worth it.

  9. Sarah Says:

    I took 17P with my twin pregnancy last year and made it to 34 weeks. I would certainly take it again. Apart from the sore back side I did not notice side effects. I would take anything to not have my babies in the NICU…

  10. Ryann Says:

    I delivered both of my children early, the first at 32 1/2 weeks and the second at 31 weeks due to a bicornuate uterus. I wonder if the injections can help with that??

  11. Tina Says:

    I had a pre-term birth in 2007 my Daughter was born at 24 weeks due to my cervix being short. She survived for 9 months before passing. I became pregnant with my Son and starting the 17P at 16 weeks to 36 weeks some soreness at injection site and like any hormone a little moody. I am currently pregnant again 35 weeks along this time and I am taking 17P again with no complaints. I also agree that this form of treatment will outweight any side effect progesterone could have. Thank GOD for March of Dimes and the miracles they provide for our babies born too soon.

  12. Kristin Blais Says:

    I delivered prematurely at 26 weeks and lost another at 14 weeks. The pain of losing my children hurts me everyday. I was overjoyed to see 17P gain FDA approval. Should it help other families avoid the pain, our family has endured from losing a child prematurely, then that is a big step in a positive direction. Additionally, it seems to me the benefits outweigh the risks. I would never wish another mother have to spend 3 months in the NICU with their preemie. I would never wish another child have to endure the complications associated with prematurity. Again, I feel this is a good thing all around and only hope better things come from this!

  13. Tasha Says:

    I have lost my last 2 pregnancies 1st @ 21 weeks due to a full placental abruption, the second @ 17 weeks bc my water broke early and a partial placenta abruption.I’m 11 weeks pregnant now and just started spotting and cramping. I’m due to start this shot at 16 weeks! I’m praying I’ll make it that far and that the shots will help!!!

  14. Cassie Springer-Sullivan Says:

    In my first pregnancy, my identical twin girls, Kate & Ella, were born at 31 weeks’ gestation. Kate is a happy toddler, but Ella developed NEC at 14 days old and passed away three days later. When I was pregnant again 18 months later, I did these injections from weeks 16-34, and I carried my daughter, Megan, to term. She is now a robust 5-month old! The accumulation of the oil from the injections became more sore and irritated at the injection site over time, but the fact that I had Megan full term was a miracle and I would recommend the injections to anyone!

  15. Jeni Says:

    I lost a daughter born at 19 weeks and a son born around 25. The third pregnancy I took injections of Progesterone. My son was born at 35 weeks and I did start have contractions at 32 weeks but they were stopped. Thanks to the Progesterone I now have a healthy baby boy who was 5.8oz and born on Father’s Day. Yes, he was still early but a lot further along than the other two pregnancies. The most problems I experienced was headaches and a little rash where I got the weekly injections. Was it worth it?…YES!!! I have my miracle child that many of us thought would never be…someday, I hope for one more.

    Tasha- Good Luck. Your situation sounds very similar to mine. I had a lot of cervical length scans and the Progesterone. I will admit that I never stopped worrying…even now that my son is 7 months old. lol I will keep you in my thoughts! Keep the faith…it is possible!

  16. Sara Says:

    I agree with Christy! Anything to help my baby grow and develop in my womb is better then a NICU! I would welcome any amount of pain to be able to keep my baby in my womb!! I am hopping to get a chance to use 17P with #3. I have a 32 weeker after PROM at 27 weeks and a history of PTL at 26 weeks

  17. Lindsay Says:

    Thank you all for your comments. Many of you have such inspiring stories.

  18. Amy Says:

    So excited to start my 17P!!!!!!!

  19. JettsMama Says:

    We are coming up on our son’s 1st birthday! This article couldn’t have come a better time. In my head, I’m already reliving the night my water broke with no explanation. Jett was a 27 weeker, and he is now healthy and strong after 3 long months in the NICU at Duke. I welcome anything that might help him have a brother or sister carried to term!! Yay March of Dimes!!!

  20. Dounia Says:

    I am currently 16 weeks and trying to get approval for this injection..medco is giving me a hard time…has anyone had to go through medco?

  21. Kara Says:

    So happy to hear this news. I had a 35wk daughter from PROM and a 31wk son from PTL. I would have done anything to carry them longer and not go through the experience of the NICU and prematurity. I am so happy that as a result of this amazing medical advancement, more families will be able to carry full term babies. Thank you for everything you do, March of Dimes :)

  22. Lindsay Says:

    Best wishes for full term arrivals! You can carry on this conversation in our online community called Share You Story: http://www.shareyourstory.org/

  23. Christine Says:

    My twins were born premature at 24 weeks and sadly did not survive. We were blessed with another pregnancy and 17P weekly injection was recommended. I had to be induced and we now have a happy healthy 2 year old little girl. I would recommend these shots to anyone who has had preterm or premature delivery. Our doctor is a highly regarded perinatalogist and he assured me this is a naturally occuring horomone and there is little evidence there are any negative effects to the child or mother. I would whole heartedly recommend using this 17P injection to anyone who may have the slightest concern.

  24. Jennifer Says:

    I thought that 17P was suppose to be used with women carrying one baby? It seems like it is being used with women carrying twins also. Does anyone know why they recommend it be used with a woman carrying only one baby and not more?

  25. SHERICA Says:

    i have an incompetent cervix that shortens early around the middle of the second trimester, will this shot be helpful for me

  26. Lindsay Says:

    Hi Sherica –

    We can’t say for certain that this will help you, but it definitely is worth discussing with your health care provider. The American College of Obstetricians and Gynecologists (ACOG) recommends that progesterone (17P) be given when:
    * A woman is currently pregnant with one baby and
    * She previously delivered a baby before 37 completed weeks of pregnancy. Either labor began on its own, without the use of drugs or other methods, or the membranes surrounding the baby in the woman’s uterus ruptured too early.
    ACOG says that progesterone may also be given to women who have a short cervix.

    Best wishes – Lindsay

  27. Shawna Says:

    I am currently taking the 17P… I was 27 weeks 5 days when my middle child was born and has Spastic Dyplegia… My husband and I decieded early to do everything we could to prevent another preterm baby……. I feel no diffrent and things are going as planned. So far I have passed the 28 week mark and look forward to a full term baby

  28. Vance Pirkle MD Says:

    Thank you March of Dimes for your support of Makena. We had an effective medication, 17P, that cost $10-$20 a week. In part, because of March of Dimes support for FDA approval, the cost is now $1500 a week for the same medication given at the same dose. Wow. FDA approval was supposed to increase access to this medication by overcoming financial barriers? A 20 week treatment that previously cost $400 now costs $30,000. And will be delivered exclusively by a company, KV pharmaceutical, that sold and distributed unapproved drugs in 2008 and required enforcement actions by the FDA for “significant violations of current good manufacturing practice (CGMPs) or adverse event reporting requirements that also make unapproved drugs” according to the FDA website listed below. 17P was a great drug at a very affordable cost. Now, with the approval of Makena, will be out of reach for many and will significantly increase the healthcare costs for all.
    http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm228670.htm

  29. Lindsay Says:

    Thanks for your comment about the pricing of Makena.

    The FDA’s decision to approve Makena will help ensure that a consistent drug will be more widely available to prevent premature births. We play no role in the pricing of products. We have discussed the price with the manufacturer, Ther-Rx, and have received their assurance that no medically eligible women will be denied the drug due to inability to pay. Financial assistance is available through the Makena Care Connection, an assistance program. The patient assistance program for Makena covers both uninsured and insured patients, and is based on income eligibility requirements. The Makena Care Connection is available by calling 1-800-847-3418. Hours of operation are 8 a.m. to 9 p.m. EST, Monday-Friday.

  30. Vance Pirkle MD Says:

    I didn’t know that there was a problem with the availability of 17P. I have been using it for several years with no problems in supply. Also, the medication used in the study that proved 17P effective was compounded. The cost is about $20 per dose for the same stuff that prevented preterm labor. How is making a medication 100 times higher in price going to increase availability. KV Pharmaceuticals, who will manufacture the drug, was cited in 2008 by the FDA for “significant violations of current good manufacturing practice (CGMPs)”. These violations were for continued manufacture and distribution of unapproved FDA drugs. Is is a company who you trust to produce a good quality medicine for our mothers? It may be true that KV Pharmaceuticals will give some medicine away for public relations purposes. The medicine probably cost less than a dollar a dose to manufacture. However, Medicaid and insurance companies will not be so fortunate. And in the end, hard working Americans will ultimately pay a high price in increased health premiums and increased Medicaid taxes. We went from $400 per patient treatment to $30,000 with absolutely no measured benefit. This is a great example of what is wrong with medicine in America. If the March of Dimes does not condem these events, shame on you.

  31. Jim Says:

    I agree with Dr. Pirkle. The drug development was entirely funded and invented years ago as Delalutin (17p). The study that allowed Makena to get FDA approval was paid for by you and me through the tax funded NIHCD. KV added no value. None whatsoever! If a women has to pay the 20% co-pay it could cost $6,000. Really! What does the OB/GYN get paid? Does that seem fair. The drug is available. Google “17p compounding pharmacies” and get 2,640 sites. I think the $1500/shot price will undoubtedly put the treatment out of the reach of many. This is a small example of everything wrong with American healthcare…and the MOD helped!

  32. Debra Says:

    I will stop all referrals to March of Dimes until you take a stand against KV’s ridiculous cost gouging that will cost all of us – those paying premiums, those paying taxes (Medicaid) and those who don’t fall in the cagegory for “assistance” such as those with higher incomes but still struggling for various reasons, those with high deductible plans and others. You are accepting huge amounts of money from this company and therefore they have you in their pocket. This is an outrage and I can no longer consider MOD an agency who puts people first. How can you in good conscience support this robbery and contribution to exhorbitant health care costs in an out-of-control economy?

  33. Lindsay Says:

    Thanks for your comments Debera. We share your concern.

    We play no role in the pricing of products. We have discussed the price with the manufacturer, Ther-Rx, and have received their assurance that no medically eligible women will be denied the drug due to inability to pay. Financial assistance is available through the Makena Cares Connection, an assistance program.

    In addition, on Monday, the President of the March of Dimes, Dr. Jennifer Howse, sent a letter to KV Pharmaceutical CEO Greg Divis expressing our serious concern about the price of Makena. We want you to know that March of Dimes is committed to ensuring that all women who are prescribed the drug are able to get it. You can read a copy of that letter here: http://www.marchofdimes.com/mar15_2011.html

    On our Advocacy page, you will see our stance on health care and access to care issues and can sign-up for our advocacy alerts–alerts we send you when there is important legislation that affects the health and well being of the people that we fight for: Moms and Babies. http://www.marchofdimes.com/advocacy/advocacy.html

    Again, thank you for your comments.

  34. Kelley Says:

    I am very discouraged to hear of the recent happenings with the 17P shots and the drastic increase in price. I delivered my first child at 25 weeks with no known cause and no risk factors. I went on to carry my second child to term with the help of 17P. I am very healthy and educated. My husband and I both hold very good jobs as an engineer and teacher. However, it is doubtful that we would ever qualify for any assistance in paying for 17P with the cost increases and covering the cost of pocket or even with some help for insurance could financially devastate us. I am sickened by the greed of gouging the price. I understand that costs increase and you need to make a profit but raising the costs for a pregnancy needing 17P from about $400 to $30000 is absolutely shameful. March of Dimes should be fighting strongly against this. I hope that you will reconsider your decisions in hopes of benefitting babies and mothers.
    Sincerely,
    Neva Krug

  35. Lindsay Says:

    Neva – We, too, are extrmely upset by this. Please read our current letter to Greg Divis, President of Ther-Rx Corporation.
    http://www.marchofdimes.com/mar23_2011.html

  36. Kerri Says:

    Everything always has a risk factor to it, but with my daughter, I had pre-term labor and premature rupture of my water. She was born at 24 weeks and passed away 37 days later. My doctor has told me that 17P could help stop pre-term labor this time around and I’m willing to try anything to not go through the pain of losing another child. I pray that all of us needing 17P have healthy happy pregnancies followed by endless years with our beautiful babies!

  37. Lindsay Says:

    Kerri – I’m so sorry you lost your daughter. If you do decide to try again, I sincerely hope 17P works for you and that you deliver a full-term healthy baby. Best wishes.

  38. christine Says:

    I feel awful for the women who has lost children due to preterm labor and I am glad they have this med for those who really need it.. I am 32 weeks and have been on 17p makena injections for a little over two months I have never had a pre term labor but i do have rapid deliveries meaning i usually go at 37 to 38 weeks but my deliveries only last 30 min or less so my dr decided to put me on this med. I agreed to it at first but then started worrying if it were going to make me carry over and will it make my deliveries more intense and longer bc thats not what i signed up for… My dr had mentioned the possible inducing and I want no part of being induced or having any kind of drugs for pain during delivery, I wanted to be a natural birth where my body had control of when i go in labor not a dr or medication,, when i asked to be taken off of the shot he threatened to drop me as a patient if i do. I do not feel makena was intended for people w my particular situation and i feel its just a way for my dr to time my pregnancy as they do w c-sections. I have googled to find statistics on wether the test subjects had to be induced and how far they carried after discontinuing the shot and of course they leave that info out so if u know anything please fill me in bc I am to the point that i am just going to b finishing out my pregnancy w no dr just to not do these shots.. I dont want to but i feel my hands are tied and i have no choice w my own body!!! just a piece of history i have three children my first i carried naturally no meds to 38 weeks my second i carried naturally to 38 weeks no meds and my last naturally to 37 this is my fourth child and i have never miscarried

  39. Lindsay Says:

    Except for the occasional individual, I have not heard of women taking 17P needing to be induced at the end of their pregnancy. There is no evidence that we have found that having taken 17P increases the lenghth or severity of labor.

    Your doctor may be mentioning induction once you are at term in able to ensure that you are in a hospital setting since you tend to have extremely short labors. We recommend you make a list of questions about this and use it to start a discussion with your doc. This should help you understand each other and formulate a plan that works for both of you.

    Best wishes – Lindsay

  40. Suzann Says:

    I for one am thankful to the March of Dimes and Makena. My third daughter was born at 32 weeks and we nearly lost her to NEC. I have been receiving the injections for 6 weeks now in hope of carrying to term. My husband and I are also both employed with “good” jobs and despite a high combined income we qualified for some assistance through Care. The medication is costing me $50 out of pocket per vial (a vial lasts a month). I wish people would become a little more informed before bashing two companies that have saved the lives of countless infants. I was offered the cheaper compounded formula of P17 but declined. That drug is not approved or regulated by the FDA and when it comes to my and my baby’s life I would not gamble on an unapproved drug. Educate yourselves before spouting off against those who have saved children’s lives. If you have questions, talk to your physician. They are the experts on this topic, not a site where anyone can comment.

    As for side effects…my headaches stopped after the first 3 shots. But the intense burning seems to get worse every week. It last only a day or two and is intermittent. I have also developed trouble sleeping, which is a first in my life including my 4 pregnancies, so I wonder if it is a side effect. All of the above being insignificant compared to the suffering of a preterm baby.

    Good luck to you all.

  41. Lindsay Says:

    Hi Suzann – Thanks for your kind words and for sharing your experiences with us. We wish you a long and healthy pregnancy.

  42. Mary Says:

    Does anyone know the average time after the last does of Makena is taken and labor begins.

  43. Cindi Says:

    I’m currently taking Makena with my third child and I just want to say even though the pharmacy gave me the run around and I started taking it a little late. The Makena company was very helpful and dropped the price down to a.price I could afford to insure that I get my medicine. I don’t think they are all about making money if so they wouldn’t have dropped my price $850 to $75 for a vial of medicine I am very thankful for.this drug and I.actually feel more assured since it is FDA approved

  44. Rachel Says:

    I am in the process of getting approved through my insurance company and learned that without insurance, the price is $900 per shot!!! I’m worried that I won’t be able to afford the shots even with my insurance! I have 3 children…the first 2 delivered at 36 weeks exactly and the 3rd delivered at 35 weeks and 6 days. I really want to be able to use these shots but i don’t know if that’s going to be possible!

  45. Lindsay Says:

    Rachel – Financial assistance is available through the Makena Care Connection, an assistance program. The patient assistance program for Makena covers both uninsured and insured patients, and is based on income eligibility requirements. The Makena Care Connection is available by calling 1-800-847-3418. Hours of operation are 8 a.m. to 9 p.m. EST, Monday-Friday. Read more about it here:
    http://www.makena.com/pages/hcp/care-connection/

  46. Rachel Says:

    Ok…thank you so much!! I’m trying to find every way possible for me to be able to take this shot! My family is against it but from what I’ve read here…it seems to be what is best for my baby!

  47. marie Says:

    I had 4 loses all around 5 to 6 months why? my doctor don’t know on my first 2 I only ate well took care of my self and that’s it on the 3rd I started the progestone pill baby came out at almost 5 months my 4th I did prenatal pills progestone makena even the cervical cercloge 2 weeks later my baby’s heart stop beating and had to be induce to deliver now I’m pregnant I am taking care of my self I’m of work I was on progesterone eating well prenatal vitamins and now I will start the makena I’m iffy about it because what is the diffrents about progesterone pill and the makena shot I don’t want my cervix relax I want it strong

  48. shanna Says:

    First of all, I would like to say I had my first born daughter at 27 weeks. The next 3 months watching her fight to survive and grow in a NICU were frightening. Thank God that she is a healthy 7 year old with no known health problems. When I became pregnant with my 2nd daughter, the 17p shot was introduced to me early on. I did my research and came to the same conclusion as most of you, this shot could be the blessing my body needs to carry a full term baby. Well it was! My 2nd and 3rd daughter were both carried to 37 weeks! Both chubby, healthy, and beautiful babies! Now. The only questions I have are about the shot and diabetes. I am a type 2 diabetic since 17. In the days following my injections, I noted spikes in my blood sugar when diet and health hadn’t changed. On a more serious concern, the information I can find on the shots all say there have been no side effects on the children, but each one say in children younger than 4. Well my 4 year old has had behavioral issues since 2. And my 1 year old is showing signs of the same issues. I’m not saying this couldn’t be genetic ( both mother and father are stubborn). But where is the research and studies done to follow these children further than 4?! Why aren’t we following them into school age? It would be nice to know that someone was following up on the children. That’s all. If I was to become pregnant again, I would definitely take the shots again.

  49. Lindy Says:

    Starting my shots this week and scared. Just from some of this side effects I’ve read about and I can’t really find any legal legit info if it’s harmful to the fetus at all. From what I read in the comments it will be ok. I delivered my 1st at 34 weeks she was early. Then my last one I went into labor at 32 weeks and thank god they stopped it and I was on bed rest for the remainder of the pregnancy. So this one I’m starting the shots this week and just nervous the more I think about it :-( I’m sure the baby and myself will b ok. I hope there isn’t any long term problems.

  50. Davita Says:

    Such amazing stories, excited to start 17P at 16 weeks!!!!

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