It's to the point where our office needs to hire someone to just do this all day. So fingers crossed ", "I had my son 3 months early and almost lost him and was on pills every 3 hours to stop preterm labor, lost a son at 20 weeks preg due to him being to small to make it when my water broke, sat in the hospital for 3 months taking those pills every 3 hours With one daughter and a constant in drip of magnesium to have her at almost term, then when my husband and I got pregnant again we were concerned, they mentioned the Makena injection but it would go in upper buttocks every 7 days ..I tried it in hopes it would work and sure enough I had her on my scheduled due date with out one complication or preterm labor symptoms , now pregnant with our last child, which I again did the Makena and am at 39 weeks without complications! All of my children were born premature, each born earlier than the last. If it's more than an inch or so off, it burns so bad! AMAG sent patients to speak at the FDA committee meeting in 2019. But its honestly worth it if I can stay pregnant for at least 10 more weeks . I was given told the shots were very expensive. The seven dissenting members recommended keeping the. But to echo everyone else, stopping progesterone is not an option. So it was considered a major breakthrough when the NIH released the results of its study in 2003, showing 17P was effective at preventing delivery before 37 weeks' gestation for many women who had previously experienced preterm birth and were carrying a single baby. So a little background, about 9 years ago I was pregnant with my daughter. In the months and years after the meeting, the FDA repeatedly asked the company to gather more scientific data on the drug. He was perfectly healthy though, in the NICU for 3weeks, which was amazing compared to his sister who spent 4 months. The accelerated process is aimed at helping patients at risk of serious health problems who dont yet have treatments. ", "This shot is by far the worst pain you will Three years after the FDA approved Makena, yet another company acquired rights to the drug. I got it in the hip and if it is done right and injected slowly, the pain is not as bad as when it isn't. That was more than double the rate for white mothers. They had to lay me down and cool me off. A recent large study unequivocally failed to demonstrate that Makena reduced the risk of preterm birth, agency scientists explained in a 2020 memo. There was only one unexplained.. And because the drug was already considered the standard of care, a lot of American women were taking it. I have been getting makena progesterone shots weekly since 16 weeks (now 34.4 weeks) so I don't go into preterm labor. The findings raise substantial concern for prescribing the drug during pregnancy, the scientists concluded. American babies are at far higher risk of dying before their first birthdays than those in almost any other wealthy country. 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. Compare all 8 medications used in the treatment of Premature Labor. I went in for my 20 week ultrasound today, and my hi-risk ob said a new study came out 2 weeks ago stating that Makena does not work and those not taking it shouldn't. Then came questions. And a few hours after the shot I get strong contractions, pelvic pressure, and cervical pain. Roughly 1 in 10 infants were born prematurely in the U.S. in 2018, according to the Centers for Disease Control and Prevention. 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. Before it was acquired by Covis, AMAG had paid to be a member of the council since at least 2017, according to the leagues website. The company is also listed as a premier member of the societys corporate council. It was not hard to get the FDA to see the need for a drug that might reduce the risk of having a baby too soon. The company also said the drug is safe. Violation Reported Report as Inappropriate M The corporate plan took years because FDA scientists and outside experts questioned whether the drug was effective and safe. Horsey said she told them she had decided not to get the injections with this pregnancy and they initially pushed back. We provide materials that disclose funding and include links to our website at every meeting we attend, she said in a statement. If you feel a message or content violates these standards and would like to request its removal please submit the following information and our moderating team will respond shortly. Experts say its not that simple, These doctors sexually abused patients. Been having contractions like crazy but still no baby hoping to have her soon. My first shot, 10 mins later walking out of the doc office I got extremely hot, dizzy, and couldn't walk straight, I almost passed out. Reviews may be edited to correct grammar/spelling or to remove inappropriate language and content. . At the time, Makena's manufacturer struggled to compete with the cheaper, compounded 17P. Cohn said in an interview that her group decided to investigate the long-term effects of Makena because of its similarity to another synthetic hormone called diethylstilbestrol, or DES. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Hopefully this helps someone like me that was curious on the pain of the shot itself. The California Medical Board has reinstated a number of doctors who sexually abused patients, a Times investigation found. You need to contact your doctor, Makena, insurance company, and pharmacy until someone makes them affordable. This is a drug that has never been shown to have clinical benefit, he said. But what would be worse than being honest with patients, he said, would be for us to mislead them by recommending an intervention that has no evidence that it works which is essentially, what is being done in prescribing Makena.. ", "4 years ago my 1st pregnancy i went into preterm labor at 26 weeks. Typical dosing for hydroxyprogesterone (Makena) Preventing early labor: Your healthcare provider will inject 250 mg (1 mL) into your buttock muscle once a week until you are 37 weeks pregnant or have delivered your baby. Dont make your decision based on people who are more concerned with a bruise than they are of the chance of having a healthy baby. The agency continues to monitor the database, she said, as well as complications reported in clinical trials. By then, the drug had been purchased by KV Pharmaceutical Co. That additional trial which ultimately showed the drug did not work would take eight years. 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. Kaiser Health News is a nonprofit, editorially independent program of the Kaiser Family Foundation. I havent experienced any side effects other than soreness for about 10-15 minutes after the injection. My doctor did know a drugstore that made their on progesterone injections. The Food and Drug Administration has granted a hearing on the Center for Drug Evaluation and Research's proposal to withdraw approval of Makena (hydroxyprogesterone caproate injection, 250. Makena has since effectively cornered the market. Many practicing obstetricians have been prescribing some form of the drug as standard treatment since around 2003, when the smaller clinical trial a National Institutes of Health study showed that the synthetic hormone 17-hydroxyprogesterone caproate, or "17P," was effective in preventing preterm delivery in women with a history of preterm labor. It went into the pockets of thousands of American obstetricians. Thats the elephant in the room that no one is willing to address.. Most at risk are Black babies. Share your journey! ", "I had my daughter at 35 weeks so with this pregnancy it was suggested I start the shots at 16 weeks until 36 weeks. I havent had any noticeable side effects as others mentioned, I sometimes get an itchy lump but it goes away in a few days. Makena is not for use in women who are pregnant with more than one baby (twins, triplets, etc). Ive never had pain in or around the injection area after the initial shot. In recent years, the league has become more friendly with corporations. Note that once you confirm, this action cannot be undone. The drug got the green light through the FDA's. My last appointment my doctor checked my cervix and it wasn't dilated yet but my cervix was soft, I have a appointment coming up this Thursday to see if she's head down still and if there is any change in my cervix, we are waiting for labor and can't be more excited. My first was born early due to PPROM. Important Safety Information for Makena (hydroxyprogesterone caproate injection) Makena should not be used in women with any of the following conditions: blood clots or other blood clotting problems, breast cancer or other hormone-sensitive cancers, or history of these conditions; unusual vaginal bleeding not related to your current pregnancy, yellowing of the skin due to liver problems during . But it was totally worth it. I'm 30 weeks now. She is a healthy happy 8 yr old now (I thank God everyday) My son was born at 32wks weighing 3lb 15oz. (to stop contractions). ", "So far so great. We are so encouraged to find an ally and champion of maternal health in Representative Dean, the alliance wrote on its website, and look forward to continued engagement on this issue with her office., Tim Mack, a spokesman for Dean, said the alliance had not disclosed that it was funded by Covis during the July meeting. I am now 36 weeks and due for my last shot so for me its worked and the experience hasnt been bad at all. Hydroxyprogesterone rating summary 6.8/10 average rating 142 ratings from 162 user reviews. 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. I declined makena injections this time around because my MFM at the time said it didn't prove to make a difference in preventing preterm labor. But, more recently, a larger trial of lower-risk, international patients a study conducted by the drug's manufacturer, after the FDA's request suggested that the medicine did not work. The totality of data on Makena supports its continued positive benefit-risk profile and the need for continued patient access, the company said in a statement. The Times found that academic physicians hired as consultants by AMAG later wrote articles about how Makena was effective, how its side effects were little to worry about, and why doctors should not trust the cheap versions of the drug available at compounding pharmacies. You did it! On Jan. 7, she gave birth to a girl at 38 weeks, which is considered full term. 2005-2023Everyday Health, Inc., a Ziff Davis company. AMAG is currently listed as a platinum funder the designation for companies giving the most. Dont take no for an answer. ", "My first baby my son I gave birth to him at 35 &5 he was 5 pounds & 11ounces, supposed to be due in March but came in February he had to stay in the NICU for 2 weeks. It invites corporate executives to pay to sit on its health advisory council. ", "I had a premature baby at 24 weeks old. "It's not like, Oh, they're going to be fine," he says. AMAG soon became a top financial supporter of the society and its events. Hello all -. I had the shots once a week in my thigh( a lot less painful than hip) rotating legs every week. Its been about an hour since my shot & I still have bad pain. Theres always assistance out there. The gold standard of evidence here is the randomized trial results, he said. I get them in my butt cheek and they do not hurt! I get the injections in my hip (I am a little lady) so far my cervix is measuring perfectly, unlike the other two. Google "FDA Advisory Board Votes to Recommend Withdrawing Progesterone Therapy for Preterm Birth" to find article", "I am 37 wks pregnant with my 4th child. Barbara Cohn, an epidemiologist at the Public Health Institute in Oakland, and three other scientists published a study in November that found a higher risk of cancer among the offspring of 200 California women who had taken 17P during their pregnancies in the 1950s and 60s when it was sold under the Delalutin name. My hip is sore for a couple days, thats it. Placement is key with getting it not to burn like heck. So far, pending a final FDA decision, Makena is still on the market. Group Leaders communicate with staff moderators and escalate potential violations for review, but they dont moderate discussions. The natural hormone progesterone is essential for a pregnancy, but scientists have never been able to determine how adding a synthetic version might help women take their pregnancies to full term. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Find advice, support and good company (and some stuff just for fun). Just found out I reached my max copay assistance with Makena and have to pay full price after what insurance didn't cover (which insurance only covered $15). Also, the majority of participants in the NIH trial about 59% were black, while the vast majority in AMAG's trial about 89% were white. 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. I seriously cried on some of those because the pain was so bad. My insurance didnt pay for Makena for me. We comply with the HONcode standard for trustworthy health information. The story of Makena shows how pharmaceutical companies can use Americas drug approval system to make hundreds of millions of dollars from a cheap, decades-old medicine with questionable effectiveness and safety. Group Black's collective includes Essence, The Shade Room and Naturally Curly. Theres no direct correlation that says Makena helps reduce the risk of PPROM. Covis and doctors who are advocates of the drug say Makena has few side effects and it would not harm patients to continue sales while more research is done to try to show it is effective. Makena Covis added that the amount paid for Makena by most payers was substantially less than its listed price, which it claims is not accurate. Group Leaders arent expected to spend any additional time in the community, and are not held to a set schedule. Its takes at least 6 weeks from start to finish to complete this process. The associations website lists AMAG as an industry partner. The company gave at least $200,000 to the association in 2018, enough to become a sponsor of its Presidents Cabinet. Dr. Kimberly Hickey, chief of maternal-fetal medicine at Walter Reed National Military Medical Center in Bethesda, Maryland, and a member of the FDA panel that voted for Makena to be withdrawn, says even if the drug is pulled from the market, obstetricians will seek out whatever version of its active ingredient remains for sale. I am 37wk tomorrow 100% effaced and 1.5 dilated. I am now at 28 weeks ..my cervix is the picture of perfection and I'm so happy!!!!! Find advice, support and good company (and some stuff just for fun). treatment of Premature Labor. They said I had an incompetent cervix . Please specify a reason for deleting this reply from the community. The views expressed in community are solely the opinions of participants, and do not reflect those of What to Expect. The shot is pretty painful at first but after the first few you get used to soreness/ itchiness. In 2014, the manufacturer went bankrupt and sold Makena to AMAG Pharmaceuticals, which owns the drug today. I miss my baby boy I lost him May 14 2019. I do have lots of lumps at the injection sites and they itch even 2-3 weeks after getting it. Doctors fear that the only drug approved to prevent preterm birth, the nation's leading cause of infant mortality and disability, will no longer be available to expectant mothers. It's main goal is to keep your cervix from changing prematurely. In 2018, AMAG gave cash or gifts to 5,800 physicians as its sales reps promoted Makena, according to a ProPublica analysis of a federal database. AMAG also gave money to the American College of Obstetricians and Gynecologists, the nations largest professional association for doctors caring for pregnant women and their children. progesteronein it, which helps prevent contractions. She had a similar experience with the drug three years before with her second pregnancy. And they told investors they had a grander plan. Some studies have found that DES may harm even the third generation. 1995-2023. Im on the makena right now next week is my last dose I'll be 36 weeks next week so far so good for me I'm just praying my little angel stays in til the due date in Nov congrats to you all God bless and take care. I'll follow-up with a post baby post to share when he actually came vs. with my daughter for those still questioning. Hey yall! 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 . after you stopped makena, did your water break or did you go into labor? This is the longest I've ever been pregnant and I believe Makena is to thank for that. In 2006 the FDA asked a committee of outside experts what they thought of the trials data. This educational content is not medical or diagnostic advice. Find patient medical information for Makena intramuscular on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Nemours Children's Health and KidsHealth are registered trademarks of The Nemours Foundation. Hello! In a press release noting its victory, AMAG said at the time that about 38% of patients were taking compounded 17P instead of Makena. 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. 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. If the study finds that it does not reduce premature labor, there is no point in me taking them. Stephen Chasen, professor of clinical obstetrics and gynecology at Weill Cornell Medicine in New York, said he cares for many minority women at risk of preterm birth. I noticed when air hit my arm it hurts more. I highly recommend the Makena shots. This medication is available in an injectable form (in an auto-injector or a vial) to be given directly . I previously ppromed at 33.5. 55% of reviewers reported a positive experience, while 23% reported a negative experience. The childrens rate of cancer of the brain, colon and prostate was especially high. I started getting the makena shot at 17 weeks until 35 weeks. Your post will be hidden and deleted by moderators. Ive been paying 400 bucks a month for the past two pregnancies!!! I had my first daughter at 34 weeks and runs in the family pre term later. In comparison, at a birthing center, she said, midwives become partners with their patients throughout their pregnancy and birth. 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 am now 30 weeks pregnant. They then soon met with staff from the office of Rep. Madeleine Dean, a Pennsylvania Democrat. So thankful since I just had a previous lost late November.So Im wondering if Im the only one having side effects from my progesterone injection shot. But he pointed out that by far the majority of the patient volunteers in the large trial that prompted the FDAs push to remove the drug went on to have a delivery at full term whether they took the drug or the placebo. has an average rating of 6.9 out of 10 from a total of 133 reviews But critics say, for a clinical trial ultimately intended to prove whether Makena works for American women at a high risk of preterm birth, AMAG's trial was deeply flawed. Your post will be hidden and deleted by moderators. Covis, which took over sales of Makena when it purchased AMAG Pharmaceuticals late last year, declined to make executives available for interviews. I was nervous at first but decided it was with the chance if I could avoid having a premature baby again. It cost my husband and I 200 out of pocket for 10 shots ( 400 dollars total). We are right on the cusp of needing them I guess. Covis repeatedly cited the two groups recommendations for prescribing Makena in documents it submitted to the FDA demanding the drug stay on the market. The group had gathered and analyzed dozens of studies from around the world on interventions aimed at extending pregnancies. AMAG told the FDA that it had had difficulty enrolling enough women who fit its criteria in the United States because if a woman was already taking 17P, generally speaking, then she was not eligible for the study. When Makena first arrived, doctors, advocates and, eventually, members of Congress objected to its high price. She was hit with migraines and depression soon after starting the shots. It works. She pointed out that obstetricians prescribing Makena are protected from bad outcomes because they can show they are following guidelines issued by their professional societies. ", "My OBGYN recommended to take Makena. I was on it from 20 weeks to 36..they say 12 days after you stop the shot you go into labor, that was true for me as well. TRIGGER SHOT: All of your shots are important, but the trigger shot is THE most important shot that you will take. It will not help anyone who has an incompetent cervix etc. The views expressed in community are solely the opinions of participants, and do not reflect those of What to Expect. She pointed to a disclosure in a single sentence at the bottom of the alliances website and at the end of two brochures that said Covis had provided the funds to create the new group. Insurers, including government programs like Medicaid, refused to cover it. Relying only on the case study can be very dangerous, Gillen said, referring to the stories of individual patients. He said he appreciated hearing from patients because it helped him understand how devastating it can be to have a child born prematurely. Covis has continued to promote Makena, emphasizing a need by Black women, who are most at risk of preterm births. Tesla Mexico plant means $10-billion investment, Nuevo Leon governor says, Assistants kindly request that you stop calling them assistants, Working more on the weekends? Currently 34+4 weeks with my second. Group Leaders arent expected to spend any additional time in the community, and are not held to a set schedule. It didnt work, said Horsey, 24. After multiple analyses, the agency said, it was unable to identify a group of women for whom Makena had an effect.. In a slide presentation in 2015, the executives described a $1B Makena Market Opportunity. They calculated $1 billion in annual sales based on getting 140,000 pregnant women to agree to more than 16 injections during each of their pregnancies with net revenue earned for each shot of $425. Please whitelist our site to get all the best deals and offers from our partners. I have heard from others the injection are very expensive but they have ways to help lower your payments. Makenas lack of effectiveness has not reduced what Covis lists as the drugs price currently $803 per weekly shot, according to GoodRx, which tracks national prices set by drug manufacturers, or about $13,000 for the full course of injections often prescribed during a pregnancy. It's awesome! Note: All information on KidsHealth is for educational purposes only. Sibai had been one of the researchers in the 2003 study of the drug and during the meeting he was called on repeatedly to answer questions. Doctors are torn between two clinical studies of the drug that had differing results: An older trial of American patients at high-risk of having a pre-term delivery showed Makena's active ingredient seemed to be effective. 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. Makena needs to be given started at 16 weeks, but it is well after 22 weeks before our patients are getting injections, by this time most of our patients have already delivered their previous babieswhich was not a good outcome. And if the FDA complies with the recommendation of its advisory panel to order Makena off the market, the action might remove all options for treating premature labor. Also, it is a MIRACLE drug and I would pay that any day of the week. You may occasionally receive promotional content from the Los Angeles Times. Durdin said she had heard similar stories from Black women who felt their doctors didnt listen when they raised concerns. Roughly 1 in 10 infants were born prematurely in the U.S. in 2018, according to the Centers for Disease Control and Prevention. Starting at 16 weeks I started my Makena shots, I had an adverse reaction to the injections, as many stated, site injection, itching, burning, and swelling that lasted a about a week, on top of drowsiness, and next day pelvic pain that caused me inability to walk. There's a prescription medication called Makena (hydroxyprogesterone caproate injection) that's given to women who are. She pointed out that early in the eight-hour meeting Krop had told the committee that the obstetricians and other experts the company had invited to speak had been paid by AMAG for their time and travel expenses. At the time, a weekly dose of the compounded drug cost about $10 to $20. But in 1999, Bristol-Myers Squibb, the company then selling it, asked the FDA to remove its federal approval after many doctors lost interest in prescribing it. The only side effect I had was my urine was very strong for a couple days, and the shots do sting and hurt for a couple hours. The FDA does not have to accept the recommendations of its expert panels, though typically it does. But the drug doesnt work, according to the Food and Drug Administration. Create an account or log in to participate. It is so worth it to be able to hold your healthy baby after birth. It also tells your body not to get ready for labor thus keeping you pregnant. Rarely, some women get blood clots or have allergic reactions. Please stay on it the full length of time. Drug companies have often used the voices of patients to try to influence regulatory decisions. Another option is the daily suppositories- I am on them and my MFM says they work just as well as the shots (sometimes better depending on your condition in my case). I finally remembered what nurses were the best and requested them. I stopped both at 35.5. And the committee agreed unanimously that there must be more study of whether it might cause miscarriages or stillbirths. While doing research and asking appropriate questions you will know that the shot isn't 100% effective to stop preterm labor. Lungs and digestive systems may not be fully developed. The mothers had agreed to participate in the Child Health and Development Studies, a group who received prenatal care between 1959 and 1966 at Kaiser Permanente in Northern California. Yes the shot in the butt hurts and you stay sore about 4 days. "Now it is clear it is not effective," she says. Doctors have been treating pregnant women with the synthetic hormone known as 17-alpha hydroxyprogesterone caproate, or simply 17P, since the 1950s. ", "Thinking about stopping Makena shots. The uterus contracts during labor to help "push" a baby out of the womb for delivery. It is the. We never knew the alliance was paid by the manufacturer, Mack said. 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. According to the Centers for Disease Control and Prevention, preterm birth is more common among babies born to black mothers. 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. Compounding facilities can be difficult to find. On October 5, 2020, the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) proposed withdrawal of approval of Makena (hydroxyprogesterone caproate injection . Opinion: How has American healthcare gone so wrong? Im deeply considering stopping my shots once this batch runs out at 32 weeks, assuming my body is still cooperating. Another concern: There was only one clinical trial the 2003 study funded by the government that had shown the drug lowered the risk of preterm birth. I stopped taking the shots at 36 weeks and we had our beautiful baby girl at 37 weeks. Many of the women at risk of preterm birth, and the babies they have, are on Medicaid. They are super painful. A spokeswoman for the FDA said that the presence of a report in the database does not mean the drug caused the adverse event.. "And especially in big systems, you are discouraged from using non-FDA-approved medicines when there is an FDA-approved medicine available. She reminded them of the side effects she had suffered from the shots in two earlier pregnancies and how, despite taking the drug, she had still delivered her babies too soon. They are the auto injection ones though and quite intimidating. "No, they're not." I had my 1st at 26 weeks. As with any shot, there's a risk of minor side effects like redness and soreness at the shot site. Those professional groups should be working to change the system, Durdin said, so people can have better care and more time with their practitioners., There is absolutely no accountability, Durdin said.