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. It will not help anyone who has an incompetent cervix etc. 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. Nemours Children's Health and KidsHealth are registered trademarks of The Nemours Foundation. I am currently 37 weeks and still pregnant and not dilated at all. It goes away, then I get my next shot and it starts up again. The scientists also warned there was not enough information on whether it might harm childrens learning, behavior and reproduction. 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!! 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. If the FDA blocks further sales, a treatment that many doctors and patients rely on will disappear overnight. This is just my experience and feelings", "For the first pregnancy I had a pre-term labor, I started taking progesterone vaginal pills, this time around I decided to go with the Makena shots, I was super scared of how much it would hurt, I had my first shot today, the shot itself wasnt so bad but the after hurts. 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. 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. Women in the progesterone group got weekly injections of the drug starting at 16 to 20 weeks of pregnancy and continuing until 36 weeks of pregnancy. 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. This educational content is not medical or diagnostic advice. But they did say if they would have to give fluids it wouldve been a 3+ day stay. On Jan. 7, she gave birth to a girl at 38 weeks, which is considered full term. ever feel, it wasnt so bad when it went on your buttocks but behind your arm is painful and it stays sore for days . My doctor is having me do it again with this pregnancy and of course I'd rather be on the safe side..baby first. 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. I havent experienced any side effects other than soreness for about 10-15 minutes after the injection. 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. 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. More than 310,000 women have taken Makena during their pregnancies since 2011 when the FDA rejected concerns of outside experts as well as one of its own scientists and approved the drug. Find patient medical information for Makena intramuscular on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Babies born early (before 37 weeks of pregnancy) can have health problems, including breathing and feeding problems, vision problems, and learning problems. 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.. My first was born early due to PPROM. hi I am in the same boat. The company is also listed as a premier member of the societys corporate council. Then came questions. Relying only on the case study can be very dangerous, Gillen said, referring to the stories of individual patients. I highly recommend the Makena shots. So I will no longer be taking makena, as it is causing my body more harm than good. That information answered some of the questions posed by the agencys team of scientists reviewing the drug, but it never was able to convince one member of that group. The company would then get an exclusive license to sell it and the ability to raise its price. Thankfully my insurance completely covered the cost of the shots. 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 FDA approved 17-hydroxyprogesterone caproate (Makena) in 2011 as a way to prevent preterm birth in women with a prior spontaneous preterm birth. I am currently pregnant now with a girl and I started to get my shots done at 21-22 weeks because my insurance took forever to get back but when I got them in my buttocks, yes it hurt a little and it did sting a little but I think any shot you get is gonna do that, after a while I was fineno lumps, no bruising, no pain. Giving them an extra few days or weeks in the womb can be transformative. 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. The correspondence that Covis and the alliance separately sent to the FDA mirror each other in key ways. 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. Violation Reported Report as Inappropriate M ", "4 years ago my 1st pregnancy i went into preterm labor at 26 weeks. 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. Based largely on AMAG's findings, the FDA's expert panel recommended in October, in a 9-7 vote, that the FDA withdraw its approval of Makena. Stopping Makena Shots early Currently 34+4 weeks with my second. 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. just 1 day thankfully due to low glucose levels. Doctors began prescribing DES to pregnant women in the 1940s. In comparison, at a birthing center, she said, midwives become partners with their patients throughout their pregnancy and birth. My insurance didnt pay for Makena for me. "Ultimately, we felt pressured into prescribing the Makena because it was FDA-approved," Peaceman says. For the same dose, Makena, the branded version that emerged in 2011 and cornered the market, cost about $1,500 from the get go. Makena will not stop premature labor that has already begun. 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. It wants the FDA to allow it to keep selling the drug while it performs additional studies aimed at trying again to show that Makena helps patients or certain subgroups like Black women. I just found out I have GD (due to shot) and Im not happy and am not paying for these shots once 2021 hits. Makena Progesterone Shots? 57% of reviewers reported a positive experience, while 22% reported a negative experience. 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. I get it in my hip and alternate sides weekly. Brand names: Makena Hydroxyprogesterone has an average rating of 6.8 out of 10 from a total of 142 ratings for the treatment of Premature Labor. Yet, both of her babies were born prematurely and Horsey said she suffered from Makena side effects, including migraines and depression. 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. KV introduced the drug at a list price of more than $1,400 a dose, or nearly $30,000 for the 20-week course of injections needed during many pregnancies. 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. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. 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. The companys money didnt just go to the medical societies. "They're not just going to say, 'I'm not going to treat you.'". Thats the elephant in the room that no one is willing to address.. My last shot was due at 35w6d that night my water broke so never got the last shot and not sure if it really worked for me or not. They then soon met with staff from the office of Rep. Madeleine Dean, a Pennsylvania Democrat. Today I went in for my injection and they did not bring my shots from the other location to the one I was being seen at. What to Expect supports Group Black and its mission to increase greater diversity in media voices and media ownership. The shot is pretty painful at first but after the first few you get used to soreness/ itchiness. In 2019, more than 14% of births to Black women were preterm, compared with just over 9% of births to white women. I have been getting makena progesterone shots weekly since 16 weeks (now 34.4 weeks) so I don't go into preterm labor. And they told investors they had a grander plan. Post your pictures. 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. Theres no direct correlation that says Makena helps reduce the risk of PPROM. There's no direct correlation that says Makena helps reduce the risk of PPROM. It explained last year that its scientists had analyzed the clinical trials, hoping to find that if they separated the data by the race of the mother they could find it helped some groups. Definitely worth getting the shot instead of having a preemie in the NICU. Or gone in to labor yet? There is no role for industry in the development of ACOGs Practice Bulletins, Zahn said in a statement using an abbreviation for the association, and ACOG neither solicited nor accepted any commercial involvement inthe development of the content of the Practice Bulletin., Kerri Wade, a society spokeswoman, said that the group has a strict conflict-of-interest policy and industry has no input into the societys clinical guidance, health policy initiatives, research, or the specific educational content.. I started taking the Makena injections at 16 weeks after having my first born at 27 weeks. 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. Progesterone treatments are also used in women at risk for preterm birth. ", "So far so great. 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. It took some fighting, but my insurance pays for it 100%. The drug remained available, however, at compounding pharmacies that could make it at a doctors direction for about $15 a dose. 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. Covis repeatedly cited the two groups recommendations for prescribing Makena in documents it submitted to the FDA demanding the drug stay on the market. By early the next year, he had personally received an additional $50,000 from AMAG, according to a federal database of payments that pharmaceutical companies give to doctors. I didnt have any bad side effects other than the injection site sometimes itching. ", "After having my first child at 27 weeks. The study found that treatment with. He said it is hard to tell his patients that there is no drug he can recommend. Your post will be hidden and deleted by moderators. 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). 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. Ive never had pain in or around the injection area after the initial shot. Dont stop!!!! In 2011, sensing a market opportunity, a drug manufacturer jumped in to offer Makena the only branded, FDA-approved version of 17P. Please stay on it the full length of time. He survived. For specific medical advice, diagnoses, and treatment, consult your doctor. 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 is the. AMAG is currently listed as a platinum funder the designation for companies giving the most. Daniel Gillen, professor and chair of statistics at UC Irvine, sat on the 2019 committee. ", "I had my daughter at 35 weeks so with this pregnancy it was suggested I start the shots at 16 weeks until 36 weeks. They recommended it be taken off the market. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. . The nonprofit group was created in 1899 by social reformers trying to improve working conditions. Anyone on here stop taking their Makena injections to help prevent preterm labor with having a previous preterm 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. 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. Doctors have been treating pregnant women with the synthetic hormone known as 17-alpha hydroxyprogesterone caproate, or simply 17P, since the 1950s. Group Leaders communicate with staff moderators and escalate potential violations for review, but they dont moderate discussions. treatment of Premature Labor. Please select a reason for escalating this post to the WTE moderators: Connect with our community members by starting a discussion. AMAGs former chief executive did not respond to messages seeking comment. The company also said the drug is safe. It didnt work, said Horsey, 24. We strive to provide you with a high quality community experience. Poor maternal care, especially of Black, Native American and Latina mothers, has long been associated with preterm births. Its safety profile for the mother and baby are well established, Covis said in a statement to The Times. The company said it saw a billion-dollar opportunity.. 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. His message: Makena works and is safe, and to take it off the market would have catastrophic consequences. Has any one else experienced this? The panel voted 19 to 2 that the trial had failed to show that the drug reduced deaths or serious health problems in infants. 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. The drugs written label lists both as possible complications. Patients from the United States made up just 23% of participants in the study. I had the shots from 16 to 36 weeks. 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. ", "I had a premature baby at 24 weeks old. Reviews may be edited to correct grammar/spelling or to remove inappropriate language and content. The company was also giving Sibais employer large financial grants. A Group Leader is a What to Expect community member who has been selected by our staff to help maintain a positive, supportive tone within a group. The views expressed in community are solely the opinions of participants, and do not reflect those of What to Expect. 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. You cant stop them early, most women go into labor 7-15 days after their final shot. 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. 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. It's awesome! I do have lots of lumps at the injection sites and they itch even 2-3 weeks after getting it. Roughly 1 in 10 infants were born prematurely in the U.S. in 2018, according to the Centers for Disease Control and Prevention. I'll follow-up with a post baby post to share when he actually came vs. with my daughter for those still questioning. Covis added that the amount paid for Makena by most payers was substantially less than its listed price, which it claims is not accurate. They had to lay me down and cool me off. Luis Davilla/Getty Images Experts say its not that simple, These doctors sexually abused patients. Now I am currently stoping Makena last week. 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. There is no way this drug should still be on the market.. Your post will be hidden and deleted by moderators. 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. Find advice, support and good company (and some stuff just for fun). I truly believe I have the makena shots to thank for that. Lungs and digestive systems may not be fully developed. 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. Note that once you confirm, this action cannot be undone. The doctor told me I was far enough along to go ahead and stop the shots. The earlier they are born the higher their risk of serious lifelong disabilities or even death. 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. 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 spokesperson also pointed out that the FDAs decision to recommend the drugs removal was not because of safety concerns but because of conflicting efficacy data. The company believes that both the 2003 study and the new trial confirmed the drug was safe, the spokesperson said. 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 uterus contracts during labor to help "push" a baby out of the womb for delivery. In 2014, the manufacturer went bankrupt and sold Makena to AMAG Pharmaceuticals, which owns the drug today. I am so happy to have been able to use in pregnancy. I get them in my butt cheek and they do not hurt! If the study finds that it does not reduce premature labor, there is no point in me taking them. The big problem is the whole doggone system. Please specify a reason for deleting this reply from the community. Ive been on the alternative since 16 weeks and Im currently 26 weeks. This is the longest I've ever been pregnant and I believe Makena is to thank for that. 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. Share your journey! "No, they're not." Note: All information on KidsHealth is for educational purposes only. 1995-2023. I wondered if anyone had feedback on them (I will post in 3rd tri too). Makena is not for use in women who are pregnant with more than one baby (twins, triplets, etc). Tomorrow I have an appointment and going to ask him to stop giving me the shots because I cant feel like This every single day..", "I had my first child at 28w 5d baby stayed in NICU for almost 3 months but perfectly healthy now and 4 years old! After the meeting, the companys payments to Sibai increased sharply. Images provided by The Nemours Foundation, iStock, Getty Images, Veer, Shutterstock, and Clipart.com. 1 weather alerts 1 closings/delays Watch Now 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. 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. On Tuesday, October 29, the Food and Drug Administration's Bone, Reproductive, and Urologic Drugs Advisory Committee panel met to discuss the approval status of Makena (hydroxyprogesterone caproate injection) for reducing the risk of preterm birth in women with a singleton pregnancy who have . Part of a slide presentation that AMAG Pharmaceuticals gave to investors in 2015, detailing how it would sell Makena. The price hike was immediate. 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. call makena care connection and ask for the copay assistance. But the about-face from the expert panel about the drug's usefulness has left all sides trying to figure out their next steps. My OB said you tend to go into labor about a week or two after stopping them. As doctors stand by for the FDA's decision on withdrawing Makena from the market, many have suggested they will turn to compounding again, if Makena disappears. 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. Reviews that appear to be created by parties with a vested interest are not published. Krop did not respond to messages asking for her comment. Decades later, scientists found it could cause rare cancers in the mothers children.