Last year, the agency stirred controversy when it used the rules to approve the drug Aduhelm for Alzheimers disease despite a lack of data showing that it slowed dementia. FDA advisers vote to recommend preterm birth drug Makena be removed It is the. I stopped mine at 35 weeks and was induced at 37 and my son did not want to come out lol Id take them until 35/36 weeks. You can suck it up if your more concerned with having a healthy baby. Brittany Horsey of Baltimore was prescribed the drug Makena during two of her pregnancies because doctors believed she was at risk of giving birth too soon. YES. If you've had a premature baby in the past, your doctor may prescribe progesterone shots during your current pregnancy to help prevent early labor. They are discussing the old way to inject into the hip or buttocks. Good luck and sending prayers for you other mommas out there in the same boat and for healthy babies!!!! Hey yall! At the time, a weekly dose of the compounded drug cost about $10 to $20. Note that once you confirm, this action cannot be undone. In 2017, a study of the drug's cost by researchers from Harvard University found no notable difference between the outcomes of women who took Makena and women who took compounded 17P even though the mean per-pregnancy cost of Makena was $10,711 more than 17P. I highly recommend the Makena shots. I'm 30 weeks now. Melody Petersen is an investigative reporter covering healthcare and business for the Los Angeles Times. This medication is available in an injectable form (in an auto-injector or a vial) to be given directly . It's awesome! This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. I had bleeding throughout the pregnancy due to SCH which resulted in PPROM at 29 weeks, and she was born at 32 weeks. He survived. hi I am in the same boat. Covis gave the money to create the Preterm Birth Prevention Alliance to a well-known consumer group in Washington, D.C., called the National Consumers League. ", "The Makena new way the administer the auto injection is HORRIBLE. It was supposed to over $1,000 once my deductible started over this year, so you may want to call them and see if they can help out at all. Find advice, support and good company (and some stuff just for fun). He was perfectly healthy though, in the NICU for 3weeks, which was amazing compared to his sister who spent 4 months. A Group Owner is a member that has initiated the creation of a group to connect with other members to share their journey through the same pregnancy & baby stages. And the shot sight itches a lot. Thats a troubling thing to find out.. The continuing support of Makena from the two professional groups of obstetricians has helped back those recent prescriptions causing some doctors to question the groups acceptance of the corporate cash. We respect everyones right to express their thoughts and opinions as long as they remain respectful of other community members, and meet What to Expects Terms of Use. I have been getting makena progesterone shots weekly since 16 weeks (now 34.4 weeks) so I don't go into preterm labor. And in August, the association published new guidelines on preterm birth, continuing to recommend Makena for certain patients but not mentioning that the FDA had recommended it be pulled from the market. Learn more about, Yes definitely do as these other ladies suggested I personally would be worried about stopping them that early in my case I had a 25 week baby in 2013 but in 2016 while pregnant with my daughter I was the vaginal inserts and she was delivered at 38 weeks but this time I'm on the makena injection and my doctor had to submit 3 rejected request then finally went threw makena connections and I was approved so ive been getting them since 16 weeks now 26.2 so yes its worth trying to speak to makena connections, Twins & Multiples: Your Tentative Time Table. My doctors suggested I use the makena injection to prevention going into premature labor again. Makena Problems and Uncertain Future Leads To Removal Of Pregnancy Drug Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Its almost like a pulsing pain that comes and goes every couple mins. I've only had 3 shots so far and they recommended I stay away from it because of the discomfort. I have heard from others the injection are very expensive but they have ways to help lower your payments. I seriously cried on some of those because the pain was so bad. From a statistical perspective, the information and data submitted do not provide convincing evidence regarding the effectiveness, Kammerman wrote at the top of her 58-page review of the drug in 2010. It points to favorable older trials also disputed by the FDA, and its asking for more time to prove to authorities that Makena works. 1995-2023. After multiple analyses, the agency said, it was unable to identify a group of women for whom Makena had an effect.. Federal officials reported in March that 10.23% of the nations births were preterm in 2019 the fifth-straight annual rise. That decision would also be made by the FDA, after receiving the recommendation of a different panel of experts on compounding, says Jeremy Kahn, an FDA spokesperson. I kept them going and at 33 weeks I went in and was 4cm dilated with bulging bags. Makena received accelerated approval from the FDA in 2011 as a drug that could reduce the risk of preterm birth in women who have a history of spontaneous preterm birth - the only such drug of . Multiple phone calls to Makena, Specialty Pharm, Patient's insurance, and the patient take place during this time along with MULTIPLE faxes and notes in the chart. Kaiser Health News is a nonprofit, editorially independent program of the Kaiser Family Foundation. I had my first daughter at 34 weeks and runs in the family pre term later. Reviews that appear to be created by parties with a vested interest are not published. Women are encouraged to ask questions, she said, and the visits are long enough to get advice on nutrition and even how much water to drink. Stopping Makena Shots early Currently 34+4 weeks with my second. Yes the shot in the butt hurts and you stay sore about 4 days. Orchid Health tells would-be parents its test can identify embryos with the lowest likelihood of developing cancer, schizophrenia and other diseases. Makena will not stop premature labor that has already begun. So I will no longer be taking makena, as it is causing my body more harm than good. Anyone on here stop taking their Makena injections to help prevent preterm labor with having a previous preterm baby? think twice before sharing personal details, foster a friendly and supportive environment, remove fake accounts, spam and misinformation, delete posts that violate our community guidelines, reviewed by our medical review board and team of experts. Compare all 8 medications used in the treatment of Premature Labor. Would i be crazy to stop my injections at 32 weeks? In August the FDA granted Covis a hearing to again review the evidence on the drug. "Ultimately, we felt pressured into prescribing the Makena because it was FDA-approved," Peaceman says. Theyre daily and you have to wear a pad after you put them in, but I have managed to get to 26w on them when I lost my first to PTL at 23w. Hormones have very broad potential impacts on the body, Cohn said. Thats the elephant in the room that no one is willing to address.. Its been about an hour since my shot & I still have bad pain. hide caption. 57% of reviewers reported a positive experience, while 22% reported a negative experience. This is my 3rd pregnancy taking them- first having the auto injection in the arms in the past they would give in the upper hip. I previously ppromed at 33.5. The drug Makena is widely prescribed to women at high risk of going into labor early, though the latest research suggests the medicine doesn't work. The group had gathered and analyzed dozens of studies from around the world on interventions aimed at extending pregnancies. The companys continued push to sell the drug, as well as decisions by the nations top societies of physicians caring for pregnant women to continue to recommend it, has troubled and angered some doctors. The correspondence that Covis and the alliance separately sent to the FDA mirror each other in key ways. ", "Thinking about stopping Makena shots. In less than 10 years, the makers of Makena had pushed its competition, particularly low-cost compounding pharmacies, out of the market. 55% of reviewers reported a positive experience, while 23% reported a negative experience. A Group Owner is a member that has initiated the creation of a group to connect with other members to share their journey through the same pregnancy & baby stages. But they did say if they would have to give fluids it wouldve been a 3+ day stay. Sales reached $387.2 million in 2017 before starting to decline. And it has already required Covis to caution patients about problems such as blood clots, diabetes, hypertension and depression in the written label that comes with a prescription. Babies born early (before 37 weeks of pregnancy) can have health problems, including breathing and feeding problems, vision problems, and learning problems. Scientists also have questions about Makenas longer-term effects. It said, for example, it had recently reduced the net price of Makena paid by purchasers including state Medicaid programs, which cover the poor. I wasnt offered care connection. Almost 12 weeks and my OB suggested Makena progesterone shots starting around 16 wks - our first was born early at 35 weeks and 5 days. Ive never had pain in or around the injection area after the initial shot. The big problem is the whole doggone system. And the American College of Obstetricians and Gynecologists recommended that all pregnant women who fit that criteria be given 17P. Driver shot and killed after 'reaching for gun' during traffic stop The panel voted 19 to 2 that the trial had failed to show that the drug reduced deaths or serious health problems in infants. That was more than double the rate for white mothers. Its okay to say it didnt work for you but to tell others to risk the health of their baby based on the fact it fails for some is infuriating. The Times found a rising number of death investigations across the country were complicated or upended after transplantable body parts were taken before a coroners autopsy. Its takes at least 6 weeks from start to finish to complete this process. It took some fighting, but my insurance pays for it 100%. Under a red letterhead logo depicting a mother and child, the Preterm Birth Prevention Alliance asked to meet with Janet Woodcock, the acting FDA commissioner, to share their members concerns about the plan to halt sales of Makena. I do not get the bumps, itchiness, burning, etc symptoms like lost people I have read. "And especially in big systems, you are discouraged from using non-FDA-approved medicines when there is an FDA-approved medicine available. They then soon met with staff from the office of Rep. Madeleine Dean, a Pennsylvania Democrat. Cutting off all access to the drug, whether it is Makena or its compounded versions, would be "a big disaster," especially for women in disadvantaged communities who are at a higher risk of preterm birth, says Dr. George Saade, the director of maternal-fetal medicine and chief of obstetrics at the University of Texas Medical Branch at Galveston. That study was flawed. Instead, 61% of women involved in the trial were from Russia and Ukraine countries that have notably different demographics than those of the United States. Makena has since effectively cornered the market. Poor maternal care, especially of Black, Native American and Latina mothers, has long been associated with preterm births. This educational content is not medical or diagnostic advice. ", "So far so great. The company was also giving Sibais employer large financial grants. Babies born prematurely can have problems breathing or digesting food or experience bleeding in their brains, among other life-threatening risks. She didnt have to spend anytime in the NICU at all unlike our son did. When Makena first arrived, doctors, advocates and, eventually, members of Congress objected to its high price. Haven't talked to dr yet as I just found out today that I would have to pay over $3000 for a months supply for the next 3 months. Find advice, support and good company (and some stuff just for fun). In South Los Angeles, Kimberly Durdin, a Black midwife at Kindred Space LA, said a visit for pregnancy care in the mainstream medical system may last just five minutes. A desktop display of the homepage of makena.com with information about the drug Makena. AMAG paid the University of Texas Health Science Center a total of $215,000 in 2019 and 2020 for a research study of one of its experimental drugs that involved Sibai. Much of that money, he says, was reimbursement for consulting, travel and fees.). The Times found similar contributions going back to 2015. Makena's lack of effectiveness has not reduced what Covis lists as the drug's price currently $803 per weekly shot, according to GoodRx, which tracks national prices set by drug. On Jan. 9, AMAG announced that because of "uncertainty" over Makena, it would divest itself of two of its other drugs, including one that was approved by the FDA last summer. I am currently 37 weeks n 4 days. I was nervous at first but decided it was with the chance if I could avoid having a premature baby again. In 2006 the FDA asked a committee of outside experts what they thought of the trials data. I wondered if anyone had feedback on them (I will post in 3rd tri too). Makena is used to lower the risk of delivering a baby too early. She was early but no where near as early as our son was. this year I have been on makena since 17 weeks I'm now 37 weeks with no shots left I've made it :-) I was worried at first but have nothing negative to say and if your doctor recommends this for you I say do it and don't forget prayers ..", "I started the Makena auto injector at 18 weeks. Even if I did experience side effects, other than at the injection site, the fact that my cervix has not yet dilated, and I am for the first time going to give birth to a healthy, full term baby would make me choose his life over my comfort. I truly believe I have the makena shots to thank for that. The drugs written label lists both as possible complications. progesterone shots - when did you go into labor? One way AMAG kept in touch with doctors it considered opinion leaders was at the Society for Maternal-Fetal Medicine. Instead, Sibai said he had identified other factors such as a mothers smoking or diabetes that would explain the stillbirths. Have you tried calling Makena Care Connection? Most at risk are Black babies. Then came questions. And both the company and the alliance asked for another hearing where mothers, especially those who were Black, could testify on the need for Makena a request the FDA granted in August. A spokeswoman for the consumer league did not answer a question from The Times on why it had not disclosed Covis funding in the letter sent to the FDA or in presentations it gave at the White House or to Deans staff. I had the shots once a week in my thigh( a lot less painful than hip) rotating legs every week.