After every single shot this has happened and is on and off for a few days and wasnt happening before I got the shots and didnt happen with my daughter who was my preemie. Among those women is Brittany Horsey, who had just received her weekly Makena injection in 2020 when she went into labor later that day four weeks too soon. Health care providers give the shots in the back of a woman's arm, or in the hip or thigh area. We never knew the alliance was paid by the manufacturer, Mack said. When I got pregnant with my 2nd it was recommended to take the shot. But to echo everyone else, stopping progesterone is not an option. Makena is a clear, yellow, sterile, non-pyrogenic solution for intramuscular (vials) or subcutaneous (auto-injector) injection. 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. Patients from the United States made up just 23% of participants in the study. 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 Nemours Foundation. Two months later, alliance members met with the White House Domestic Policy Council, where they left encouraged by the councils receptivity, according to a note about the meeting on the alliances website. YES. If you have a nurse who administers them correctly and doesnt hit your nerve it just feels like a pinch. I'll follow-up with a post baby post to share when he actually came vs. with my daughter for those still questioning. And the committee agreed unanimously that there must be more study of whether it might cause miscarriages or stillbirths. KHN is not affiliated with Kaiser Permanente. I called their customer service line and Amax pharmaceuticals and they also have never heard of these reported side effects. In the months and years after the meeting, the FDA repeatedly asked the company to gather more scientific data on the drug. I soak in a warm bath, then have hubby rub my hip very lightly to get the fluid moving around. Group Owners uphold the core values of the brand by reporting content that violates the community guidelines. I've only had 3 shots so far and they recommended I stay away from it because of the discomfort. . Makena I havent had any contractions (besides the occasion BH that go away when I change position), or any other symptoms of labor. Been having contractions like crazy but still no baby hoping to have her soon. Stillbirths have been a concern since at least 2003, when the government trial showed a small but increased risk in women taking Makena. 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. So a little background, about 9 years ago I was pregnant with my daughter. I was nervous at first but decided it was with the chance if I could avoid having a premature baby again. Group Black's collective includes Essence, The Shade Room and Naturally Curly. Instead, Sibai said he had identified other factors such as a mothers smoking or diabetes that would explain the stillbirths. When Makena's original manufacturer sought FDA approval, it cited the NIH's results to vouch for the drug's safety and effectiveness. Its safety profile for the mother and baby are well established, Covis said in a statement to The Times. Ive told him my side effects , how every single day Im feeling dizzy, extremely fatigue, light headed and my body feels so weak I can barely walk for more than ten minutes, he tells me wait it out but I can no longer deal with it, its giving me extreme anxiety, Im only 6 months pregnant. For the same dose, Makena, the branded version that emerged in 2011 and cornered the market, cost about $1,500 from the get go. You cant stop them early, most women go into labor 7-15 days after their final shot. Some researchers are concerned that Makena could increase the risk of cancers in the children of women who take it. When Makena first arrived, doctors, advocates and, eventually, members of Congress objected to its high price. 17P has the hormone document.write(def_progesterone_T); In 2012, it sued the FDA in an unsuccessful attempt to stop compounding gaining some ground later that year when a meningitis outbreak caused by a different compounded drug drew federal scrutiny of specialty pharmacies. The Medical Board gave them their licenses back, After her botched surgery, she pitched a medical disclosure bill. 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 . Hello all -. Drug companies have often used the voices of patients to try to influence regulatory decisions. Doctors are fighting it, A Pasadena startup got billions selling COVID tests. So far, pending a final FDA decision, Makena is still on the market. A date for the hearing has not yet been set, which means thousands more women could be prescribed the drug before the agency decides whether to force the company to stop sales. 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. I started taking the Makena injections at 16 weeks after having my first born at 27 weeks. Even after the FDA said Makena should be removed from pharmacies, prescriptions for poor women covered by Medicaid are still being written at 55% of the rate of their high point in 2017, according to a December study. After multiple analyses, the agency said, it was unable to identify a group of women for whom Makena had an effect.. 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. Well, I was on them and they checked my cervix at 28 weeks and it was long. my water actually broke on its own and I had a great labor and delivery! 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. So trying to avoid the extreme out of pocket cost here. It's awesome! It cost my husband and I 200 out of pocket for 10 shots ( 400 dollars total). You can suck it up if your more concerned with having a healthy baby. Two percent of volunteers taking the drug had a stillbirth compared with 1% of those taking the placebo. The FDA recommended that Covis Pharmas premature birth drug, Makena, be taken off the market. Makena has since effectively cornered the market. An FDA database contains more than 18,000 reports of patients experiencing adverse effects, from rashes to serious problems like stillbirths. My husband administers the shots because I couldn't go to the office every week for this long. The nonprofit group was created in 1899 by social reformers trying to improve working conditions. Executives at AMAG Pharmaceuticals said they were excited about the drug because KV had put it on a remarkably strong sales growth trajectory, according to a news release. 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. 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. Complicating matters is the possibility that even if the FDA decides to let Makena remain for sale, or permits pharmacies to create their own versions of the drug for use, insurers might well refuse to pay. But compounding of 17P continued until 2016, when the FDA approved a preservative-free version of Makena and, in doing so, handed AMAG Pharmaceuticals the exclusive right to make the drug, ending the compounding of 17P. Deborah Mann Lake, a university spokeswoman, said Sibai wasnt available to comment. She didnt have to spend anytime in the NICU at all unlike our son did. Has any one else experienced this? Roughly 1 in 10 infants were born prematurely in the U.S. in 2018, according to the Centers for Disease Control and Prevention. I am also on Makena for history of PPROM. Secondly, the company planned to find ways to increase the number of injections given to each pregnant woman from the average then of 13.5 injections per pregnancy toward the maximum possible of 21 injections. 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. Is academic medicine for sale? asked David Nelson, associate professor of obstetrics and gynecology at the University of Texas Southwestern Medical Center in Dallas, and two other scientists in an article detailing AMAGs payments to the two groups. I know I can make it to 32 weeks without the injections, just praying I can make it to 36 weeks. What to Expect supports Group Black and its mission to increase greater diversity in media voices and media ownership. 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. My insurance doesn't cover mine either and it's $400 a month but I called makena care and I pay $100 a month (it's based on your annual household income). The women taking the placebo had an abnormally high rate of preterm birth, which may have exaggerated the trials conclusion. When I got pregnant again I was so worried . This company is so SLOW!! ", "This shot is by far the worst pain you will Learn more about, Twins & Multiples: Your Tentative Time Table. The scientists also warned there was not enough information on whether it might harm childrens learning, behavior and reproduction. The company told investors that it had created a publications committee made up of KOLs, or key opinion leaders a term the drug industry uses for physicians who may be able to sway the opinions of their peers. Im stopping at 33 weeks as well. I'm 30 weeks with my 2nd pregnancy & have no complications. A desktop display of the homepage of makena.com with information about the drug Makena. She added that Covis is not involved in the strategic direction of the Alliance or its activities., Covis told The Times it had been transparent in its activities with clinicians and advocates, which the company believes is in the best interest of patients.. Your treatment will generally start between 16 weeks and 20 weeks of gestation. 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 doctor told me I was far enough along to go ahead and stop the shots. I was on Makena with my 2nd pregnancy due to PPROM and delivery at 20w with my Angel. Sign up for the California Politics newsletter to get exclusive analysis from our reporters. Decades later, scientists found it could cause rare cancers in the mothers children. But its honestly worth it if I can stay pregnant for at least 10 more weeks . He was perfectly healthy though, in the NICU for 3weeks, which was amazing compared to his sister who spent 4 months. Placement is key with getting it not to burn like heck. Much of that money, he says, was reimbursement for consulting, travel and fees.). However, many withdrawn drugs are added to a federal list of drugs that may not be compounded due to failures of safety or efficacy and if Makena is withdrawn, 17P could end up on that list, too. 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. 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. That was more than double the rate for white mothers. We are still waiting on that clinically relevant data to say this drug is truly effective and outweighed by the potential risks.. Hormones have very broad potential impacts on the body, Cohn said. It hurts, but contractions hurt more ;) Anything for the safety of my baby boy. Stopping Makena Shots early Currently 34+4 weeks with my second. 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. This new auto injectable is horrible. Hey yall! 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. 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. It is so worth it to be able to hold your healthy baby after birth. The educational health content on What To Expect is reviewed by our medical review board and team of experts to be up-to-date and in line with the latest evidence-based medical information and accepted health guidelines, including the medically reviewed What to Expect books by Heidi Murkoff. Horsey, the mother in Baltimore, said that when she recently got pregnant again the doctor and staff at the clinic she visits told her she should start the Makena shots. But they did say if they would have to give fluids it wouldve been a 3+ day stay. In 2011, sensing a market opportunity, a drug manufacturer jumped in to offer Makena the only branded, FDA-approved version of 17P. 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! Some of the children who survive struggle with lifelong disabilities. Its almost like a pulsing pain that comes and goes every couple mins. 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. Despite these recommendations, Makena has been a source of debate in the Ob/Gyn community -- both because of the drug's cost and due to questions raised about the 2003 findings. 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. What the alliance did not mention in the letter was that Covis had paid to create the group. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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. Find advice, support and good company (and some stuff just for fun). The drug seemed so clearly effective in that research that researchers ended the study early. I have heard from others the injection are very expensive but they have ways to help lower your payments. It is the. Giving them an extra few days or weeks in the womb can be transformative. Compare all 8 medications used in the treatment of Premature Labor. the FDA really screwed up when they took Compounded 17OHP off the market!!!! Looking forward to a better experience in the hospital this time and getting to hold my baby immediately and have in the room with me and go home when I do :)", "I started the hip injections of this at 16 weeks. Poor maternal care, especially of Black, Native American and Latina mothers, has long been associated with preterm births. 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. ever feel, it wasnt so bad when it went on your buttocks but behind your arm is painful and it stays sore for days . 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. This is a drug that has never been shown to have clinical benefit, he said. Hello! Its been about an hour since my shot & I still have bad pain. PPROM is different than preterm labor because its not actually labor that causes the rupture, thats why an OB may not say its needed if your previous preemie was due to pprom. Good luck and sending prayers for you other mommas out there in the same boat and for healthy babies!!!! The gold standard of evidence here is the randomized trial results, he said. So I ended up in the Hospital for a month then at 28 weeks they sent me home cuz nothing changed. I'm 30 weeks now. The medical system, Durdin said, does not allow enough time to deliver the care people need to avoid slipping through the cracks.. Your doctor may even be able to get you limited Medicaid to cover them. This information is not intended to endorse any particular medication. At 18 weeks, I was hospitalized for severe pain, but fetus was growing normal, 19 weeks spoke to ob about the side effects and she said she never heard of this complaint yet. 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. aostrows member. The corporate plan took years because FDA scientists and outside experts questioned whether the drug was effective and safe. Anything the pregnant mother is exposed to, her children are exposed to and her grandchildren are exposed to simultaneously.. What is Makena? There are other ways to reduce the risk of having a baby too soon. Dont take no for an answer. I had the shots from 16 to 36 weeks. TRIGGER SHOT: All of your shots are important, but the trigger shot is THE most important shot that you will take. The FDA does not have to accept the recommendations of its expert panels, though typically it does. My cervix has been long at every check. Covis has continued to promote Makena, emphasizing a need by Black women, who are most at risk of preterm births. Please whitelist our site to get all the best deals and offers from our partners. A big reason for those deaths, more than 21,000 each year, is that too many are born too soon. Babies born prematurely can have problems breathing or digesting food or experience bleeding in their brains, among other life-threatening risks. I miss my baby boy I lost him May 14 2019. I was told to take Makena with baby number 2, due April 2, 2020. I started taking them with bumps, redness, and now itchiness. And they told investors they had a grander plan. I continued to take the injections for a total of 4 injections, after each injection, I would have the same reaction sleeping almost the entire day and pelvic pain unable to walk the next day. It points to favorable older trials also disputed by the FDA, and its asking for more time to prove to authorities that Makena works. Please select a reason for escalating this post to the WTE moderators: Connect with our community members by starting a discussion. ", "I would 100% recommend the makena shot! In a statement in which the drugmaker also announced plans for its chief executive, William Heiden, to step down, Heiden was quoted as saying that the ambiguity about Makena's future revenue "makes it challenging to invest in both our promising pipeline and in the physician and consumer marketing required to support these two new products.". treatment of Premature Labor. If that were true, why would it be prescribed to you (and me)? They are super painful. 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. 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. Or gone in to labor yet? When Do Pregnant Women Need Progesterone Shots. Also, it is a MIRACLE drug and I would pay that any day of the week. I just found out I have GD (due to shot) and Im not happy and am not paying for these shots once 2021 hits. Both the Society for Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists have continued to support the use of Makena despite the lack of scientific data that it works. I had my first baby at 36 1/2 weeks and she was beautifully healthy , 5 pounds and shes still amazing. 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. 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. They dont yet know what harm the drug could cause over the years for mothers and their children. Council members said they were not aware that money from Covis had created the group, according to the official. The uterus contracts during labor to help "push" a baby out of the womb for delivery. Three years after the FDA approved Makena, yet another company acquired rights to the drug. That child came six weeks early. This medication is available in an injectable form (in an auto-injector or a vial) to be given directly . For one thing, 35% of participants in the NIH trial had experienced preterm birth more than once, putting them at higher risk, compared with just 15% in AMAG's trial. It invites corporate executives to pay to sit on its health advisory council. ", "After two pregnancies that ended in loss at 24 weeks, my doctor did a cerclage at 12 weeks and started me on Makena injection at 16 weeks. Reviews that appear to be created by parties with a vested interest are not published. I get itchy lumps & bruises but the chance of giving birth early & risking life long complications based on being sad, crying all day is so pathetic. 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. Its main goal is to keep your cervix from changing prematurely. The Times found that AMAG had paid Sibai more than $14,000 in consulting fees and reimbursements for food and travel in the months leading up to the meeting. ", "I was 16 weeks when I started my makena generic shot 4 days later my water broke and I lost my baby and doctors have no clue to why my water broke so fast even after I took the shot. It took some fighting, but my insurance pays for it 100%. Most at risk are Black babies. There's no direct correlation that says Makena helps reduce the risk of PPROM. To increase the average number of injections, AMAG said in the slides it would launch a program of adherence/persistency that is, finding ways to keep women taking the shots even when they would like to stop because of side effects or other problems such as getting to the doctor every week. 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. I believe Makena really does work. I previously ppromed at 33.5. 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. 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). 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. This is my 4th cerclage and it was placed at 14 weeks. 55% of reviewers reported a positive experience, while 23% reported a negative experience. So I want to see what would happen if I stopped taking the injections at 24 weeks pregnant?! It's to the point where our office needs to hire someone to just do this all day. Im 23 weeks and also considering stopping after my supply runs out. Thus, for more than a decade, compounding pharmacies specialty pharmacies that typically make prescription drugs for patients who have allergies or other conditions created cheap injections of 17P for use by pregnant women. "I had my baby at 34 weeks and 6 days. 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. It works. Violation Reported Report as Inappropriate M Some disclosed that the company had paid for their travel and hotel expenses. 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. "The only problem was, no one was making it," says Dr. Alan Peaceman, the chief of maternal-fetal medicine at Northwestern University's Feinberg School of Medicine and a researcher on the 2003 study.