Thank you in advance ladies! The views expressed in community are solely the opinions of participants, and do not reflect those of What to Expect. Create an account or log in to participate. Group Black's collective includes Essence, The Shade Room and Naturally Curly. The groups membership includes more than 5,000 physicians, scientists and womens health professionals from around the world. 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. "They're not just going to say, 'I'm not going to treat you.'". This educational content is not medical or diagnostic advice. (to stop contractions). Most at risk are Black babies. This educational content is not medical or diagnostic advice. Started them 4 weeks ago and havent felt the same way ever since, I believe my doctor thinks Im being dramatic and doesnt listen to me . Ive been on the alternative since 16 weeks and Im currently 26 weeks. 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. Christopher Zahn, the associations vice president of practice activities, said the group had told its members about the FDAs action on Makena in other communications and did not see a need to include the information in the new guidelines. I am 37wk tomorrow 100% effaced and 1.5 dilated. 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 stopped at 36 weeks per my doctor and gave birth an exact week later. Progesterone treatments are also used in women at risk for preterm birth. Dont stop, Ive read most women go into labor the week after they stop. And the committee agreed unanimously that there must be more study of whether it might cause miscarriages or stillbirths. Makena remains the standard of care for many pregnant women who have given birth prematurely in the past. Instead, Covis Pharma, a Luxembourg company owned by private equity firm Apollo Global Management Inc., has continued to promote Makena, emphasizing a need by Black women, who are most at risk of preterm births. Compounding facilities can be difficult to find. It will probably be your first intramuscular (IM) shot, so be prepared to give it at the EXACT time the nurses prescribe. If it's more than an inch or so off, it burns so bad! According to the Centers for Disease Control and Prevention, preterm birth is more common among babies born to black mothers. When I was pregnant with my first son I went in at 24 weeks to find out my cervix was opening. It's to the point where our office needs to hire someone to just do this all day. Rarely, some women get blood clots or have allergic reactions. If I just went through my insurance the medicine would be ridiculously expensive, but when I called them they gave me a special co-pay ID# and now a one month supply only costs me $25.00. 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. Ive been doing the Makena shots since 16 weeks, and my cervix has remained long and strong with no change. I believe Makena really does work. There is no way this drug should still be on the market.. 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. The seven dissenting members recommended keeping the drug on the market while conducting further study. Covis has continued to promote Makena, emphasizing a need by Black women, who are most at risk of preterm births. In the months and years after the meeting, the FDA repeatedly asked the company to gather more scientific data on the drug. She was super close but made it. It didnt work, said Horsey, 24. It was supposed to over $1,000 once my deductible started over this year, so you may want to call them and see if they can help out at all. Share your journey! You need to contact your doctor, Makena, insurance company, and pharmacy until someone makes them affordable. Please help! just 1 day thankfully due to low glucose levels. It is our understanding that Dr. Sibai was compensated for the hours he spent preparing his testimony on the 2003 study, Lake said. 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. 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. 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). The American College of Obstetricians and Gynecologists has said it will continue to monitor the issue but has not changed its guidance to doctors in the meantime. . The drug was rendered inaccessible to many of the women who doctors thought needed it most. Innova Medical Group in Pasadena secured contracts worth at least $2.7 billion selling Chinese-made antigen tests to the U.K. government despite questions over their accuracy. We were taken aback by the amount of financial scope and influence in our specialty, they wrote, adding that the facts are resoundingly persuasive that doctors should not prescribe Makena. But this way is horrible", "I work at an OB/GYN office and take care of all the Makena referrals!!! We comply with the HONcode standard for trustworthy health information. 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. I am now at 28 weeks ..my cervix is the picture of perfection and I'm so happy!!!!! The Times found similar contributions going back to 2015. Would i be crazy to stop my injections at 32 weeks? But to echo everyone else, stopping progesterone is not an option. Covis gave the money to create the Preterm Birth Prevention Alliance to a well-known consumer group in Washington, D.C., called the National Consumers League. The scientists also warned there was not enough information on whether it might harm childrens learning, behavior and reproduction. 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. This company is so SLOW!! He survived. The medical system, Durdin said, does not allow enough time to deliver the care people need to avoid slipping through the cracks.. 57% of reviewers reported a positive experience, while 22% reported a negative experience. What the alliance did not mention in the letter was that Covis had paid to create the group. Last year, the agency stirred controversy when it used the rules to approve the drug Aduhelm for Alzheimers disease despite a lack of data showing that it slowed dementia. 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. It also raises questions about the influence of corporate money on American doctors, even in an area of medicine that serves one of the most vulnerable group of patients: pregnant women and their children. They had to lay me down and cool me off. For specific medical advice, diagnoses, and treatment, consult your doctor. This is the only medication that helped me complete a pregnancy. I am now 36 weeks and due for my last shot so for me its worked and the experience hasnt been bad at all. When I got pregnant again I was so worried . I get it in my hip and alternate sides weekly. Love Mackena! 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. 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. And it is reassuring to see that, really, in either one of these studies, there was no signal that 17P increases stillbirth.. 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. Theres no direct correlation that says Makena helps reduce the risk of PPROM. Currently 34+4 weeks with my second. Multiple phone calls to Makena, Specialty Pharm, Patient's insurance, and the patient take place during this time along with MULTIPLE faxes and notes in the chart. 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. A recent large study unequivocally failed to demonstrate that Makena reduced the risk of preterm birth, agency scientists explained in a 2020 memo. 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. 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? Horsey said she told them she had decided not to get the injections with this pregnancy and they initially pushed back. 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. And a few hours after the shot I get strong contractions, pelvic pressure, and cervical pain. Insurers are generally under no obligation to cover drugs just because the FDA approves them. It points to favorable older trials also disputed by the FDA, and its asking for more time to prove to authorities that Makena works. On Jan. 9, AMAG announced that because of "uncertainty" over Makena, it would divest itself of two of its other drugs, including one that was approved by the FDA last summer. I stopped taking the shots at 36 weeks and we had our beautiful baby girl at 37 weeks. But the about-face from the expert panel about the drug's usefulness has left all sides trying to figure out their next steps. It said, for example, it had recently reduced the net price of Makena paid by purchasers including state Medicaid programs, which cover the poor. I dont know if I can do this every week it was really painful !!! 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. Among its founding principles is that consumers should demand safety and reliability from the goods and services they buy.. While doing research and asking appropriate questions you will know that the shot isn't 100% effective to stop preterm labor. For the same dose, Makena, the branded version that emerged in 2011 and cornered the market, cost about $1,500 from the get go. Sign up for the California Politics newsletter to get exclusive analysis from our reporters. ever feel, it wasnt so bad when it went on your buttocks but behind your arm is painful and it stays sore for days . There are other ways to reduce the risk of having a baby too soon. has an average rating of 6.9 out of 10 from a total of 133 reviews The Medical Board gave them their licenses back, After her botched surgery, she pitched a medical disclosure bill. They recommended it be taken off the market. 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. 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. Then came questions. My husband administers the shots because I couldn't go to the office every week for this long. 1995-2023. 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. We strive to provide you with a high quality community experience. The California Medical Board has reinstated a number of doctors who sexually abused patients, a Times investigation found. aostrows member. 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. I felt my opinion did not matter, she said. Please specify a reason for deleting this reply from the community. for the It might work for some women but not all.". Hello! When Makena's original manufacturer sought FDA approval, it cited the NIH's results to vouch for the drug's safety and effectiveness. Like Covis, the alliance dismisses the results of the large new study, saying it did not include enough American Black women. "I had my baby at 34 weeks and 6 days. When Do Pregnant Women Need Progesterone Shots. Group Owners uphold the core values of the brand by reporting content that violates the community guidelines. AMAG paid the University of Texas Health Science Center a total of $215,000 in 2019 and 2020 for a research study of one of its experimental drugs that involved Sibai. I do not get the bumps, itchiness, burning, etc symptoms like lost people I have read. It feels like the start of labor. This information is not intended to endorse any particular medication. 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 . The correspondence that Covis and the alliance separately sent to the FDA mirror each other in key ways. 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. Placement is key with getting it not to burn like heck. Find patient medical information for Makena intramuscular on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. In a press release noting its victory, AMAG said at the time that about 38% of patients were taking compounded 17P instead of Makena. Stillbirths have been a concern since at least 2003, when the government trial showed a small but increased risk in women taking Makena. I was counseled Has anyone stopped Makena injections early? Hello all -. 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. ", "This shot is by far the worst pain you will Hopefully this helps someone like me that was curious on the pain of the shot itself. I stopped mine at 35 weeks and was induced at 37 and my son did not want to come out lol Id take them until 35/36 weeks. ", "Thinking about stopping Makena shots. I started taking the Makena injections at 16 weeks after having my first born at 27 weeks. The FDA says it already considered those previous trials and had not changed its finding that the drug was not effective. Many of the women at risk of preterm birth, and the babies they have, are on Medicaid. 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. We never knew the alliance was paid by the manufacturer, Mack said. 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. In recent years, the league has become more friendly with corporations. Where did you hear that its not effective for PPROM? Makena has worked great for me no problems the shot burns a little and the site itches a week later but worth not having a baby in NICU. But the Baltimore mother still suffered from the side effects. call makena care connection and ask for the copay assistance. I called their customer service line and Amax pharmaceuticals and they also have never heard of these reported side effects. Compare all 8 medications used in the treatment of Premature Labor. 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. 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.. Developed in 1953, the drug was first approved under the brand name Delalutin. Available for Android and iOS devices. Good luck and sending prayers for you other mommas out there in the same boat and for healthy babies!!!! The uterus contracts during labor to help "push" a baby out of the womb for delivery. 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.. In comparison, at a birthing center, she said, midwives become partners with their patients throughout their pregnancy and birth. There's a prescription medication called Makena (hydroxyprogesterone caproate injection) that's given to women who are. 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). You should see if they offer some kind of assistance at my job our nurse puts in an application for financial assistance through Makena and the patient often times ends up getting all payed for, good luck! I am also on Makena for history of PPROM. 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. Note: All information on KidsHealth is for educational purposes only. 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. ", A second clinical trial muddies the waters. Find advice, support and good company (and some stuff just for fun). 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. It's awesome! I looked through every one of these, Sibai told the committee. 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. But they did say if they would have to give fluids it wouldve been a 3+ day stay. Learn more about, Twins & Multiples: Your Tentative Time Table. Makena helps you get closer to term. 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. This pregnancy I started makena at 16w 3d and I got my last shot of makena at 35w 3d (arm injections) and Im now 37 weeks and 50% effaced and not dilated. 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 wondered if anyone had feedback on them (I will post in 3rd tri too). Doctors recommend starting 17P shots during the second trimester of pregnancy (usually between 16 and 20 weeks), and continuing them until 36 weeks. We strive to provide you with a high quality community experience. 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. Its main goal is to keep your cervix from changing prematurely. 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. It triggers the final maturation of your eggs 35 hours before the retrieval procedure. Im deeply considering stopping my shots once this batch runs out at 32 weeks, assuming my body is still cooperating. ", "Dont listen to ignorant people who swear against the shot & warn people not to use it. If the FDA blocks further sales, a treatment that many doctors and patients rely on will disappear overnight. I highly recommend the Makena shots. The study found that treatment with.