The findings raise substantial concern for prescribing the drug during pregnancy, the scientists concluded. My doctors suggested I use the makena injection to prevention going into premature labor again. The panel voted 19 to 2 that the trial had failed to show that the drug reduced deaths or serious health problems in infants. 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. 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. 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. For specific medical advice, diagnoses, and treatment, consult your doctor. has an average rating of 6.9 out of 10 from a total of 133 reviews I'm pregnant with my final baby and have had a cerclage placed again and my makena shots just arrived today. AMAGs former chief executive did not respond to messages seeking comment. Share your journey! I havent had any contractions (besides the occasion BH that go away when I change position), or any other symptoms of labor. We strive to provide you with a high quality community experience. AMAG sent patients to speak at the FDA committee meeting in 2019. If that were true, why would it be prescribed to you (and me)? The pregnancy that I had the cerclage and injections lasted until almost 36 weeks before I ended up with preeclampsia. Controversy Kicks Up Over A Drug Meant To Prevent Premature Birth, Scientists Search For Causes Of Preterm Birth And Better Ways To Test For Risk, Premature Birth Rates Rise Again, But A Few States Are Turning Things Around, about 38% of patients were taking compounded 17P instead of Makena, said it will continue to monitor the issue. for the This company is so SLOW!! Among its founding principles is that consumers should demand safety and reliability from the goods and services they buy.. Or gone in to labor yet? I ended up in the Hospital for another month and finally gave birth to my son at 36 weeks. I'm 30 weeks now. I get them in my butt cheek and they do not hurt! Dont stop!!!! They said if I had not had them there was a good chance I would have had him around 30 weeks, so I think its up to how much you want to risk it. 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. Makena was not proven to reduce rates of preterm birth in its long term study. 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. My doctor is having me do it again with this pregnancy and of course I'd rather be on the safe side..baby first. Thankfully my insurance completely covered the cost of the shots. But it was totally worth it. 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. The doctor told me I was far enough along to go ahead and stop the shots. North Las Vegas police: Driver shot, killed after reaching for gun Withdrawing Approval of Makena A Proposal from the FDA Center for Study finds no benefit, but possible harm, from drug - ScienceDaily FDA scientists pointed out that studies in which high doses of the drug were given to rats and other animals had not proven it was safe for human embryos, The Times found in a review of documents written by agency staff members. Using the California Cancer Registry, the scientists discovered the children of women injected with the drug were nearly twice as likely to be diagnosed with cancer than those not exposed to the drug in the womb. Its been about an hour since my shot & I still have bad pain. Thats a troubling thing to find out.. I was told to take Makena with baby number 2, due April 2, 2020. 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. His message: Makena works and is safe, and to take it off the market would have catastrophic consequences. ACOG Updates Members about Progesterone Injection. 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 Covis spokesperson said the study offers no comparison to Makena since it had been used in those earlier decades to treat a different patient population for a different purpose. The spokesperson noted that the American College of Obstetricians and Gynecologists had told its members the study had limitations and should not influence practice.. I stopped taking the shots at 36 weeks and we had our beautiful baby girl at 37 weeks. There are other ways to reduce the risk of having a baby too soon. 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. And because the drug was already considered the standard of care, a lot of American women were taking it. In a written statement, it pointed to a recent reanalysis of previous Makena trials that found evidence that the drug worked. Post your pictures. Tips from Former Patients | INTEGRIS Health 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. It is so worth it to be able to hold your healthy baby after birth. After the meeting, the companys payments to Sibai increased sharply. Ive been doing the Makena shots since 16 weeks, and my cervix has remained long and strong with no change. Ive never had pain in or around the injection area after the initial shot. We never knew the alliance was paid by the manufacturer, Mack said. 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. What to Expect supports Group Black and its mission to increase greater diversity in media voices and media ownership. Learn more about, Twins & Multiples: Your Tentative Time Table. It triggers the final maturation of your eggs 35 hours before the retrieval procedure. So far, pending a final FDA decision, Makena is still on the market. 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. I am now 30 weeks pregnant. 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. That's why seven of the 16 members of the FDA panel have argued that removing Makena's FDA approval could do more damage than simply leaving a drug on the market that may, or may not, work. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. This educational content is not medical or diagnostic advice. I seriously cried on some of those because the pain was so bad. Hello all -. A big reason for those deaths, more than 21,000 each year, is that too many are born too soon. I wasnt offered care connection. 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. Has any one else experienced this? Babies born prematurely can have problems breathing or digesting food or experience bleeding in their brains, among other life-threatening risks. Theres a chance it may help, especially if you dont know what exactly caused your PPROM, so most OBs feel its more beneficial than not to prescribe it. ", "I had 3 premature births all between 32 and 34 weeks so when I recently got pregnant with my 4th child which was a boy my doctor advised me to start the makena injections without telling me the pros or cons. I'm 30 weeks with my 2nd pregnancy & have no complications. So trying to avoid the extreme out of pocket cost here. "Now it is clear it is not effective," she says. 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. hi I am in the same boat. TRIGGER SHOT: All of your shots are important, but the trigger shot is THE most important shot that you will take. Daniel Gillen, professor and chair of statistics at UC Irvine, sat on the 2019 committee. Also, it is a MIRACLE drug and I would pay that any day of the week. Group Owners uphold the core values of the brand by reporting content that violates the community guidelines. Doctors have been treating pregnant women with the synthetic hormone known as 17-alpha hydroxyprogesterone caproate, or simply 17P, since the 1950s. Poor maternal care, especially of Black, Native American and Latina mothers, has long been associated with preterm births. 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 hip is sore for a couple days, thats it. The expert introduced by Krop was Baha Sibai, a professor of obstetrics, gynecology and reproductive sciences at the University of Texas Health Science Center in Houston. Makena (hydroxyprogesterone caproate injection) Information She was early but no where near as early as our son was. I would like to add that Yesterday the hospital did a test on my cervix to see if I would go into labor in the next 2 weeks it came back negative. It was extremely painful in my arm and the pain doesn't subside til after about 10 mins and even after that you still feel soreness. That child came six weeks early. Your doctor may even be able to get you limited Medicaid to cover them. 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.. The study, however, was not designed to show it reduced deaths or disability among infants the true goal of doctors prescribing it. 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. Group Leaders communicate with staff moderators and escalate potential violations for review, but they dont moderate discussions. Lungs and digestive systems may not be fully developed. If Makena stays on the market, doctors and insurers will be left to haggle over prescribing a drug that can cost an average of more than $10,000 per pregnancy. The drug was rendered inaccessible to many of the women who doctors thought needed it most. 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. The medical system, Durdin said, does not allow enough time to deliver the care people need to avoid slipping through the cracks.. Hey yall! So I will no longer be taking makena, as it is causing my body more harm than good. These work to reduce the risk of premature birth through a mechanism which is currently not yet fully understood. Sales reached $387.2 million in 2017 before starting to decline. Makena Intramuscular: Uses, Side Effects, Interactions - WebMD There's no direct correlation that says Makena helps reduce the risk of PPROM. Group Owners uphold the core values of the brand by reporting content that violates the community guidelines. (to stop contractions). I had my first baby at 36 1/2 weeks and she was beautifully healthy , 5 pounds and shes still amazing. 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. Find advice, support and good company (and some stuff just for fun). Then came questions. ", "Dont listen to ignorant people who swear against the shot & warn people not to use it. She is a very happy and healthy baby. I previously ppromed at 33.5. Reviews that appear to be created by parties with a vested interest are not published. In 2011, sensing a market opportunity, a drug manufacturer jumped in to offer Makena the only branded, FDA-approved version of 17P. Anyone on here stop taking their Makena injections to help prevent preterm labor with having a previous preterm baby? The price hike was immediate. Group Black's collective includes Essence, The Shade Room and Naturally Curly. Amanda Turney, a spokesperson of the agency, says there is no established timeline for when the FDA will announce whether it will withdraw its approval of Makena. My cervix has been long at every check. Nemours Children's Health and KidsHealth are registered trademarks of The Nemours Foundation. I havent had any noticeable side effects as others mentioned, I sometimes get an itchy lump but it goes away in a few days. If it's more than an inch or so off, it burns so bad! Oh and mine are $11.70 for a months supply. 2005-2023Everyday Health, Inc., a Ziff Davis company. For more than a decade, a pharmaceutical company has said it holds the key to helping those infants: a drug called Makena, which is aimed at preventing premature birth. 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. 2005-2023Everyday Health, Inc., a Ziff Davis company. The FDA says it already considered those previous trials and had not changed its finding that the drug was not effective. I really never had any issues other than some same day soreness but this time around sheesh- I feel drained an Ill be 23 weeks tomorrow!! When I got pregnant again I was so worried . 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. Please specify a reason for deleting this reply from the community. It points to favorable older trials also disputed by the FDA, and its asking for more time to prove to authorities that Makena works. Doctors are fighting it, A Pasadena startup got billions selling COVID tests. Companies often hire these doctors to write medical journal articles or give speeches to other doctors about their products. 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. 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. That study was flawed. It works. Create an account or log in to participate. 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). Makena Uses, Dosage & Side Effects - Drugs.com The FDA does not have to accept the recommendations of its expert panels, though typically it does. They are the auto injection ones though and quite intimidating. 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. Some studies have found that DES may harm even the third generation. 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. Covis told The Times it could not comment on activities of AMAG before it purchased the company. Doctors recommend starting 17P shots during the second trimester of pregnancy (usually between 16 and 20 weeks), and continuing them until 36 weeks. The significant opportunity, according to the slides, came from first trying to persuade more of the women at risk of preterm birth those who had already had one child prematurely to take the Makena shots. After multiple analyses, the agency said, it was unable to identify a group of women for whom Makena had an effect.. The FDA recommended that Covis Pharmas premature birth drug, Makena, be taken off the market. 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. 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. 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 . What Are Progesterone Shots? Hormones have very broad potential impacts on the body, Cohn said. They are super painful. "No, they're not." Each 1.1 mL Makena auto-injector for subcutaneous use and each 1 mL single-dose vial for intramuscular use contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in a preservative-free solution containing castor oil USP (30.6% v/v) and benzyl benzoate USP (46 . 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). If the study finds that it does not reduce premature labor, there is no point in me taking them. The accelerated process is aimed at helping patients at risk of serious health problems who dont yet have treatments. It's awesome! Covis has continued to promote Makena, emphasizing a need by Black women, who are most at risk of preterm births. The FDA has already repeatedly addressed the concern that stopping the drugs sale could hurt Black infants. The FDA approved 17-hydroxyprogesterone caproate (Makena) in 2011 as a way to prevent preterm birth in women with a prior spontaneous preterm birth. A letter sent to the Food and Drug Administration in May 2021 by the Preterm Birth Prevention Alliance an organization created with money from Covis. 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. Ive been paying 400 bucks a month for the past two pregnancies!!! My OB said you tend to go into labor about a week or two after stopping them. Luis Davilla/Getty Images 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. AMAG said its growth strategy included having its marketing team focus on three key groups: physicians prescribing the drug, the professional societies that those doctors belong to and the nonprofit patient groups advocating for pregnant women and their children. Do Not Sell or Share My Personal Information, Covis Pharmas statement to The Times about Makena, In the rush to harvest body parts, death investigations have been upended, A startup says it helps parents pick healthier embryos. A White House official confirmed that the Domestic Policy Council and the Gender Policy Council had met with alliance members. The scientists also warned there was not enough information on whether it might harm childrens learning, behavior and reproduction. 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. 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. 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. Covis repeatedly cited the two groups recommendations for prescribing Makena in documents it submitted to the FDA demanding the drug stay on the market. But is it worth having a healthy baby? 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. Questions about the higher rate of stillbirths were raised by experts on an FDA committee that met on Oct. 29, 2019, to discuss the drug. When I got pregnant with my 2nd it was recommended to take the shot. You did it! It cost my husband and I 200 out of pocket for 10 shots ( 400 dollars total). 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. I started taking the Makena injections at 16 weeks after having my first born at 27 weeks. Its very unsettling. I noticed when air hit my arm it hurts more. 1995-2023. It voted 13 to 8 that the safety data were adequate to support approval. Cundo necesitan inyecciones de progesterona las mujeres embarazadas? 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!