Makena Problems and Uncertain Future Leads To Removal Of Pregnancy Drug Manufacturer’s CEO
Amid continuing calls for a Makena recall to be issued, due to concerns that the pregnancy drug is not effective at preventing preterm births, the drug manufacturer faces mounting problems, which has resulted in the CEO of AMAG Pharmaceuticals stepping down.
In a press release issued to investors earlier this month, AMAG announced the departure of its president and chief executive officer, William Heiden. The company also indicates that it plans to sell off two other drugs, Intrarosa and Vyleesi, to reduce operating expenses in the face of uncertainty caused by the Makena problems.
Those concerns come in the wake of an FDA advisory committee hearing held in October 2019, which resulted in recommendations to the FDA that it remove Makena from the market. While the FDA has not issued an announcement on Makena’s fate, and its advisory committee recommendations are not binding, the agency usually follows its advisory committees’ advice.
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Learn More“We continue to believe in the significant long-term potential of Intrarosa and Vyleesi,” Heiden said in the press release. “However, the uncertainty around the long-term durability of Makena revenues makes it challenging to invest in both our promising pipeline and in the physician and consumer marketing required to support these two new products.”
Makena (hydroxyprogesterone) is an AMAG Pharmaceuticals drug, which was approved by the FDA in 2011, for prevention of preterm birth in women who had a prior spontaneous preterm birth. It is the only medication approved for this use, but it now appears that it is not actually effective.
The drug and its original manufacturer, KV Pharmaceuticals, gained national notoriety in 2011, after the company acquired the medication that was once sold by compound pharmacies for $20, and then started charging women $1,500 per injection. The FDA eventually allowed compounding pharmacies to keep selling it to get the prices lower following public outrage.
AMAG Pharmaceuticals acquired the rights to the drug in 2014.
Concerns about Makena problems rose following the results of a clinical trial, Progestin’s Role in Optimizing Neonatal Gestation (PROLONG), which found that the drug simply does not work; failing to show any clinical benefits.
In early October 2019, the consumer watchdog group Public Citizen called for a Makena recall in a petition to the agency, saying it did not make sense for the synthetic hormone to remain on the market to be injected into pregnant women, who would then face the risk of side effects without any apparent benefits.
According to a January 27 report by FiercePharma, the clinical trial and FDA advisory committee recommendations have the medical community torn over what should happen to the drug. In addition, even if the FDA does not remove it from the market, there is a possibility that healthcare insurers may refuse to pay for it.
The report indicates a spokesperson for American’s Health Insurance Plans (AHIP), a healthcare insurer industry group, said the recent clinical trial made it clear that the drug is not effective.
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36 Comments
NikitaFebruary 28, 2024 at 9:57 am
Makena traumatically altered my pregnancy causing severe health issues. My child was born 70% developmentally delayed, amongst numerous other health issues. My child passed away at 19months old.
LeeOctober 14, 2023 at 7:07 pm
Like so many others here. I was put on Makena in 2011 due the premature birth of my oldest, who's typically developing. My youngest was diagnosed with autism as a toddler. He's non-verbal, has significant cognative delays, anxiety and behavioral issues. He'll require lifelong care as a result. If I could go back I would definitely make a different choice I feel guilty constantly, and I wish [Show More]Like so many others here. I was put on Makena in 2011 due the premature birth of my oldest, who's typically developing. My youngest was diagnosed with autism as a toddler. He's non-verbal, has significant cognative delays, anxiety and behavioral issues. He'll require lifelong care as a result. If I could go back I would definitely make a different choice I feel guilty constantly, and I wish I'd known better. Funnily enough, the Makena shots and resultant aching hips were what prompted me to take tylenol during my pregnancy as well. Another drug being connected with autism that was promoted as safe for pregnant women.
AnnaAugust 10, 2023 at 10:36 pm
I also took this every Friday to full term or 3 weeks early. My son has autism level three Also nonverbal.
TiffanyAugust 3, 2023 at 5:50 am
My daughter is now 4 and recently diagnosed with autism .....I have had her in speech therapy since before she turned 4. I was told I needed this due to previous premature pregnancy . My daughter is considered high functioning but I am doing everything I can to make sure she isnt severely affected.
simonJuly 21, 2023 at 3:18 pm
I’d be interested in further scientific views on the relationship between autism and synthetic progestins. I am an independent campaigner for greater research into the link between autism and adhd and synthetic progestins and interested in the science alone, just in case we have not been looking hard enough at the mental impact in later life of in utero exposure to synthetic progestins. Of pap[Show More]I’d be interested in further scientific views on the relationship between autism and synthetic progestins. I am an independent campaigner for greater research into the link between autism and adhd and synthetic progestins and interested in the science alone, just in case we have not been looking hard enough at the mental impact in later life of in utero exposure to synthetic progestins. Of papers I have read, the most prominent question comes to mind is related to the fact that Christine Wagner’s work (Albany University), seems to offer very credible evidence of a link between synthetic progestins and autism spectrum disorder and which also explains male bias. So I am asking whether, in your opinion, is it possible that a certain subtype/certain subtypes of Autism, which is heterogenous due to its sub-types, is/are caused by perturbed gene expression during fetal brain development through in utero exposure to synthetic progestins? The theory is that some of the autism/adhd sub-types map directly to different synthetic hormones or is there a wide variety of synthetic progestins that map to autism subtypes through the timing of the exposure during pregnancy. One of the crucial pieces of evidence that drives the need for further research in my mind is Christine Wagner’s work that shows that the progesterone receptor is found to be available way before birth in the medial preoptic nucleus (MPN) and given her revelation of brain impairments in adult animals exposed to a specific synthetic progestin (hydroxyprogesterone caproate) suggests that all synthetic progestins should be looked at. This is just one of many papers published within the last few years on this: Exposure to the Synthetic Progestin, 17α-Hydroxyprogesterone Caproate During Development Impairs Cognitive Flexibility in Adulthood - PMC (nih.gov) In children who went on to develop autism increased levels of hormones were found in the womb including hydroxprogesterone caproate (Makena): In this Danish study: Increased hormone levels in the womb linked to autism (sciencenordic.com) I just thought I’d write to you and suggest that a study on cancer incidence be of interest: in terms of exposure to Hydroxyprogesterone Caproate: Exposure in the second or third trimester conferred an additional risk for the male (adjusted hazard ratio, 2.59; 95% confidence interval, 1.07-6.28) but not for the female (adjusted hazard ratio, 0.30; 95% confidence interval, 0.04-1.11) offspring Exposure in the first trimester was associated with an increased risk of any cancer (adjusted hazard ratio, 2.57; 95% confidence interval, 1.59-4.15), and the risk increased with the number of injections (1-2 injections: adjusted hazard ratio, 1.80; 95% confidence interval, 1.12-2.90; ≥3 injections: adjusted hazard ratio, 3.07; 95% confidence interval, 1.34-7.05). Exposure in the second or third trimester conferred an additional risk for the male (adjusted hazard ratio, 2.59; 95% confidence interval, 1.07-6.28) but not for the female (adjusted hazard ratio, 0.30; 95% confidence interval, 0.04-1.11) offspring. The risk of colorectal (adjusted hazard ratio, 5.51; 95% confidence interval, 1.73-17.59), prostate (adjusted hazard ratio, 5.10; 95% confidence interval, 1.24-21.00), and pediatric brain (adjusted hazard ratio, 34.72*; 95% confidence interval, 7.29-164.33) cancer was higher in the offspring first exposed to 17α-hydroxyprogesterone caproate in the first trimester than the offspring not exposed. *There were two cases of brain cancer from 234 in exposed group 15 in unexposed (15,517) (incidence in brain cancer in children is about 3 per 100,000) In utero exposure to 17α-hydroxyprogesterone caproate and risk of cancer in offspring - PubMed (nih.gov) And in this large study that link was declared as associative: Prenatal Progestin Exposure Is Associated With Autism Spectrum Disorders - PMC (nih.gov) But I highlight hydroxyprogesterone caproate because of Christine’s study and hormone levels in amniotic fluid and the large Chinese study linking Autism strongly to progestins.
simonJuly 21, 2023 at 2:45 pm
This drug is associated with autism/ adhd in several legitimate studies
CourtneyJuly 3, 2023 at 1:47 pm
By doctor told me I had to get this injection. I came in week after week and begged to come off of it but was told it was medically necessary for my baby. He is two, delayed, and being tested for autism. I’m so angry and feel helpless. How can doctors get away with this.
ElizabethMay 21, 2023 at 9:06 am
I also received this weekly injections and my child has developmental delays
CelesteApril 13, 2023 at 9:38 am
My son who is 3 is Autistic has sensory problems and he had signs of ADHD he has speech delay and me myself felt like my strength was taken away from me with every single shot that I took not only during the pregnancy but even afterwards.
KApril 5, 2023 at 5:38 pm
I had Makena and my daughter is diagnosed with ASD
RachelMarch 8, 2023 at 1:57 pm
I received this shot in 2018 to prevent preterm labor. My son has a developmental delay and has been diagnosed with Autism. I tried to get my medical records from my doctor and he's saying that he lost all my medical records from a flood that happened 7 month before my son was born (I was able to get my Medicaid billing history).
ShakimaJanuary 9, 2023 at 2:23 pm
I also took the shot in 2021 and my daughter will be 2 feb,12,2023 im also seeing a little bit of signs of autism im not sure till i get her tested i had 8 kids all together and i didnt see those signs i only took it with her i pray that its nothing but if so i still love my pumpkin patch she so small in cute
KaitlynOctober 5, 2022 at 7:33 pm
My son was born in December of 2019. I was high risk and had a cerclage because my daughter born in 2013 was a micro preemie. She has no issues now being 9 years old . My son on the other hand is non verbal speech delayed and has been in therapy for over a year . At his 2 year old check up his doctors said I needed to have him tested for autism. We’ve been on the waiting list to be screened for AS[Show More]My son was born in December of 2019. I was high risk and had a cerclage because my daughter born in 2013 was a micro preemie. She has no issues now being 9 years old . My son on the other hand is non verbal speech delayed and has been in therapy for over a year . At his 2 year old check up his doctors said I needed to have him tested for autism. We’ve been on the waiting list to be screened for ASD. I was given the mckenna shots for 15 weeks while I was pregnant with him and I can’t help but put the pieces together that they caused this because of my research. I would like to sue the company as well.
YaniraSeptember 3, 2022 at 8:42 am
I have 6 children.4 were born premature.2017 when I got pregnant the doctor told me he was going to put me on the makena shot to stop the preterm labor.1 left butt cheek 1 right butt cheek for 7 months.when my son turned 2 he started arm flapping.then came speech delay and now he is 4 and ADHD.
KaytanyaAugust 20, 2022 at 12:31 pm
I was worried about this makena shot , the first I heard about it. I asked questions and was assured by my Doctor it was a safe drug. Now my daughter is 3yrs and suffering from speech delayed and basic comprehension skills. My other 2 children who were born premature and I didn't receive makena shot with, is perfectly fine.
JessicaAugust 7, 2022 at 2:29 am
9/23/2021 Our daughter was born and she has all of this, she is number 8 of my children and never have experience anything like this. I went on the shot at 16weeks till 35 weeks Premature baby Abnormal brain MRI Brain disorder Developmental health problem Prolonged seizure Fever convulsion Acid reflux Environmental and seasonal allergies Sleep Apnea
BrittanyJuly 17, 2022 at 2:04 pm
4 children 1 full term Second and third we’re premie Last and only son I got this injection weekly My son is almost 2 and isn’t talking as he should be and we are getting him evaluated for autism It’s been back n forth in my mind that this shot did it to him I didn’t have it with any of my children except him
RachelApril 9, 2022 at 7:25 pm
My fourth just tested as having ASD, I received 17 p shots weekly with all. I was told even with a cerclage these were safe and would prevent preterm labor. I have a son previous to these four born at 22 weeks in 1992, he is not autistic. I thought after this last diagnosis how in the heck do all of them have this. It crossed my mind to google 17 p and the autism link. Amazed there is so much in[Show More]My fourth just tested as having ASD, I received 17 p shots weekly with all. I was told even with a cerclage these were safe and would prevent preterm labor. I have a son previous to these four born at 22 weeks in 1992, he is not autistic. I thought after this last diagnosis how in the heck do all of them have this. It crossed my mind to google 17 p and the autism link. Amazed there is so much information out there. I found studies linking them in 2003, I had my first in 2008. I want to determine if this could be what happened to us. I don't feel the same since then either, chalked it up to motherhood but I have terrible memory issues. I have no idea how to go about the possibility of a suit and normally that's, not my personality. However, I am now divorced, have four children under 13 on the spectrum, and their needs are so extensive. Looking for guidance. Thanks for listening.
MilmerMarch 15, 2022 at 5:48 pm
I have 3 kids, my first 2 were preterm and my last was with Makena, she is having a speech delayed and I haven’t been the same ever since i had her, these shots were so painful and got so sick from them, it’s so sad to know it has affected other people, i trusted my doctor. I been taking my daughter to a speech and neuro doctor and she is showing signs of autism. Please ladies lets all help to get[Show More]I have 3 kids, my first 2 were preterm and my last was with Makena, she is having a speech delayed and I haven’t been the same ever since i had her, these shots were so painful and got so sick from them, it’s so sad to know it has affected other people, i trusted my doctor. I been taking my daughter to a speech and neuro doctor and she is showing signs of autism. Please ladies lets all help to get this lawsuit done this is not right. My daughter suffers from so much do to these shots
KristieJanuary 23, 2022 at 12:36 pm
I was guilted into getting the shots in 2018. I questioned the safety numerous times to the nurse who injected it into me weekly . I was assured the Dr. would not give me something if it wasn't 100% safe. At my last appt. I told the Dr. she better make a notation in my file about the horrible side effects I suffered every week and my worry about the safety of the effectiveness and long term effec[Show More]I was guilted into getting the shots in 2018. I questioned the safety numerous times to the nurse who injected it into me weekly . I was assured the Dr. would not give me something if it wasn't 100% safe. At my last appt. I told the Dr. she better make a notation in my file about the horrible side effects I suffered every week and my worry about the safety of the effectiveness and long term effects on my child for when the class action suit came around. Here we are, my child just turned 3. Waiting on evaluation, but his communication skills are very delayed and he is presenting with some autistic traits. He is my 4th child. The only one that has issues. The only one I was directed by my Dr. to take for "the safety of my child". Unbelievable. I want to sue. Not for money, but for the damages, pain and suffering, the years of therapy that will follow......
VirginiaJanuary 6, 2022 at 2:47 pm
I was given makena for multiple pregnancies and both my son's one has autism and the other DDD and I suffer fibroids and pain at injection sites
TaylorJanuary 4, 2022 at 3:01 am
I was 31 weeks pregnant when we lost our son. He was still born. I started the shots around 15 weeks and each week I was adding more fluid. You could see there was too much fluid because at 28 weeks I had the fluid of a full term mom. When getting the shot it felt as if you would just expand with fluid and become bloated. Not only were you feeling this way the shot was extremely painful! The side [Show More]I was 31 weeks pregnant when we lost our son. He was still born. I started the shots around 15 weeks and each week I was adding more fluid. You could see there was too much fluid because at 28 weeks I had the fluid of a full term mom. When getting the shot it felt as if you would just expand with fluid and become bloated. Not only were you feeling this way the shot was extremely painful! The side effects after the shot has caused me to suffer from memory loss. I am so sorry to everyone on here for the loss that this has caused you all!
MeghaDecember 7, 2021 at 7:17 pm
My second child became autistic as well.. I received Makena during my pregnancy.. I would like to sue as well
ElsaNovember 21, 2021 at 7:21 pm
I had a girl who was born at 34 weeks perfectly well, with my second son they practically forced me to take the injection I never agreed, today my son has a communication and understanding problem, he is diagnosed with developmental delay and speech problem, possible autism, we are awaiting evaluation. I think it was that injection and it is not fair that this happens to him because a pharmaceutic[Show More]I had a girl who was born at 34 weeks perfectly well, with my second son they practically forced me to take the injection I never agreed, today my son has a communication and understanding problem, he is diagnosed with developmental delay and speech problem, possible autism, we are awaiting evaluation. I think it was that injection and it is not fair that this happens to him because a pharmaceutical company made a profit with his health, I also want to sue. This should not happen to any baby.
JessicaNovember 13, 2021 at 11:23 pm
I want this drug taken off the market. My first child was premature and has no developmental issues. I was put on Makena for my second pregnancy and it was a nightmare. I had every reaction possible and when I tried to stop taking it, the doctor would remind me it was for the health and safety of my child. My son is now almost 3 and just started talking, has severe sensory issues and is being test[Show More]I want this drug taken off the market. My first child was premature and has no developmental issues. I was put on Makena for my second pregnancy and it was a nightmare. I had every reaction possible and when I tried to stop taking it, the doctor would remind me it was for the health and safety of my child. My son is now almost 3 and just started talking, has severe sensory issues and is being tested for autism. This does not run in my family and my first born is completely fine. I blame the shot and don’t want anyone else to go through what my family has gone through.
MichelleOctober 29, 2021 at 12:53 pm
I have 4 children and my first 3 are all fine only 1 was born premature. With my 4th child I was placed on Makena and he is now 3 and Autistic. I would also like to sue.
PriscillaOctober 26, 2021 at 2:33 pm
I believe this medicine caused my child to be born stillborn.. I had a typical pregnancy until I was prescribed this medicine .
EsteraOctober 21, 2021 at 12:48 am
I was horribly sick on the shot and felt like no one cared or listened to me when I expressed something felt wrong. 3 years later I have hormone issues, thyroid issues weight gain and more. I have not felt normal or healthy since taking them. So disgusting to see so many women are overlooked and ignored while these companies continue to profit and not be held accountable. And doctors that seem nai[Show More]I was horribly sick on the shot and felt like no one cared or listened to me when I expressed something felt wrong. 3 years later I have hormone issues, thyroid issues weight gain and more. I have not felt normal or healthy since taking them. So disgusting to see so many women are overlooked and ignored while these companies continue to profit and not be held accountable. And doctors that seem naive or act like medications and shots don't have side effects that can be this damaging.
StephanieSeptember 17, 2021 at 12:17 am
I would like to sue. And not for compensation. But for the promise they won't give this to another woman...ever. I am the type that seldomly takes medicine even for a headache. I was backed into a corner with weekly injections. When I said I wasnt interested, I was legitimately shamed and made to feel so guilty that I did it. The injections made feel so sick for 2-4 days after recieving them ever[Show More]I would like to sue. And not for compensation. But for the promise they won't give this to another woman...ever. I am the type that seldomly takes medicine even for a headache. I was backed into a corner with weekly injections. When I said I wasnt interested, I was legitimately shamed and made to feel so guilty that I did it. The injections made feel so sick for 2-4 days after recieving them every week. I retained fluid like you wouldnt believe. I ended up gaining 90lbs during my pregnancy versus 40 with my first child. Around 25-26 weeks my blood pressure spiked. I recieved that weeks injection and made it to my car before I felt dizzy, shakey, couldnt see straight and overall just sick. I went back in and said something wasn't right. Obviously i didnt look good because they took my blood pressure which was in the upper 180's and at one point in the 190's. I was immediately hospitalized. My daughter was born at 33 weeks. I did not realize the side effects of Makena until I did my own research only to find that i was dealing with almost every single side effect. This injection that was was assured was safe for me and benefiting my baby. Every week I went in to see the MFM Doctor and expressed how miserable I was (aside from normal pregnancy issues) and she continued to inject me with this garbage every week. Since giving birth I have had a hormone problems. Thyroid problems. Random shooting pains in my upper butt and lower back where I received the injections. I could go on and on about me. But my daughter is the most important piece of the story. She is now 3 and has been diagnosed with autism. Quite frankly I dont know if I will ever get to hear my baby say I love you as she is non verbal. That is a hard pill to swallow. After researching and see a LOT of other women who took this medication to have their child be autistic as well. I have sat and beat myself up regularly thinking that I did this to her. And I did. I should have stuck to my guns. Trusted my gut and said no. But more importantly I should have been given all the facts. The side affects should have been discussed and not just being told this will prevent you from preterm labor and wont harm your baby.
CandaceJuly 20, 2021 at 5:25 am
In 2018 my obgyn shamed me into taking a Makena shot at 16 weeks. I started bleeding that night. And continued to bleed until I hit 17 weeks pregnant. I was rushed to the Emergency Room in terrible pain. On the way to my pelvic exam I gave birth in a wheelchair in the hallway. That Makena shot caused me to deliver my baby at 17 weeks pregnant.
SheritaJuly 14, 2021 at 11:54 pm
I would like to sue as well because with 5 pregnancies I used mekena and I lost 2 pregnancy and my son has Autism and he's 5. I was on Makena in 2011 and still birth my daughter early, in 2013 I was on mekena and lost my son at 5 months, 2014 I lost another son still birth and I was on makena, in 2016 I birth a son and we knew something wasn't right with him around 5months and he has been diagnose[Show More]I would like to sue as well because with 5 pregnancies I used mekena and I lost 2 pregnancy and my son has Autism and he's 5. I was on Makena in 2011 and still birth my daughter early, in 2013 I was on mekena and lost my son at 5 months, 2014 I lost another son still birth and I was on makena, in 2016 I birth a son and we knew something wasn't right with him around 5months and he has been diagnosed with autism and yes I was on makena, 2018 had another son and birth him early at 33 weeks and again had to get mekena shots. It hurt when a mother blames herself and her body for losing kids and for her sons autism when it the drugs they was giving me for each pregnancy just to keep my cervix close so my children could develope fully. It really hurts. All my research leads back to the makena aka 17p injections and yes I have all medical records from all pregnancy.
MichelleMay 4, 2021 at 3:56 am
I would like to be part of a class action lawsuit. My son has Autism and my 2 daughters were pre-term and just fine.
AnnaMarch 31, 2021 at 8:18 pm
I was diagnosed with lobular invasive carcinoma (breast cancer) within 4 years of having had Makena injections. I do not have a history of cancer in my family. My onco score was 16 and I have providers that stated they wouldn’t doubt that my breast cancer may have been caused by these injections since it is an estrogen driven cancer. I have had a lot of trouble trying to bring this in front of[Show More]I was diagnosed with lobular invasive carcinoma (breast cancer) within 4 years of having had Makena injections. I do not have a history of cancer in my family. My onco score was 16 and I have providers that stated they wouldn’t doubt that my breast cancer may have been caused by these injections since it is an estrogen driven cancer. I have had a lot of trouble trying to bring this in front of the law as I feel wronged. I now have to constantly be on guard, MRI’s every 6 months as well as mammos & other testing. It has taken a major toll on me both mentally and physically. I would like knowledgeable attorney’s assistance with this please. Thank you.
JenniferMarch 31, 2021 at 4:54 pm
I was given the makena injection and I gave birth at 20 weeks to a stillborn baby girl. I would like to find out how to speak to a lawyer about this.
ShannonOctober 1, 2020 at 8:17 pm
I have suffered a great deal as well over this drug . My son was also born severely Autistic as well as I suffered a paralysis after receiving this drug every single week.
AprilMarch 29, 2020 at 1:53 pm
I would like to find away to sue the drug makers if makena and also the drs that made me stay on makena. Or the would stop my health care and not see me. My son was born with autism and I believe the shot caused this. I had a daughter born before him that was born early at 32 weeks she had no breathing problems or anything she is now 7 and has no problems at all. So the making me go on makena with[Show More]I would like to find away to sue the drug makers if makena and also the drs that made me stay on makena. Or the would stop my health care and not see me. My son was born with autism and I believe the shot caused this. I had a daughter born before him that was born early at 32 weeks she had no breathing problems or anything she is now 7 and has no problems at all. So the making me go on makena with my 2nd caused his autism.