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Zofran Birth Defects Lawsuits: Just the Cost of Doing Business for GlaxoSmithKline?

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Boston, MATwo product liability lawsuits have now been filed against GlaxoSmithKline (GSK), the maker of Zofran, claiming the drug used during pregnancy caused their children to be born with birth defects.

Despite studies that have linked Zofran to birth defects, the drugmaker chose to market its drug off-label to pregnant women to treat morning sickness. Zofran is only approved by the FDA for use by patients undergoing surgery or cancer treatments.

Zofran lawsuits

Court records show that two Zofran lawsuits have been filed this month claiming that the drug caused children to be born with serious heart problems. A mother from Minnesota filed a lawsuit claiming she used Zofran during her pregnancies in 2004 and in 2006. Both Cheri Flynn’s children were born with serious heart defects (Case 2:15-cv-00709-PD).

Another lawsuit was filed in the U.S. District Court, District of Massachusetts, claiming a child was born with several congenital heart abnormalities. Tomesha LeClair took Zofran during her first trimester of pregnancy. LeClair’s child has undergone at least 13 different surgeries and continues to suffer from developmental delays and other health problems, according to the lawsuit, which also claims that GSK failed to warn her and her physician of this risk (Case 1:15-cv-10429).

Further, the world’s sixth-largest pharmaceutical company has been accused of bribing doctors with money and gifts to prescribe Zofran, a practice that appears to be commonplace with GSK - the number-one big pharma repeat offender. GSK since 1991 has paid a whopping $7.56 billion in criminal and civil penalties, according to Sidney M. Wolfe at Public Citizen. GSK has done its math and the cost of penalties, now likely to include Zofran birth defects lawsuits, is simply the cost of doing business.

In 2012, GSK agreed to pay $3 billion to settle a number of allegations including illegally marketing Zofran for non-approved use - but the company’s profits in that year alone were $7.7 billion.

Zofran studies

In 2014, a study that used data from the Swedish Medical Birth Register, titled “Use of Ondanesetron [Zofran] During Pregnancy and Congenital Malformations in the Infant,” showed that using Zofran during the first trimester more than doubled the risk of the child developing a cleft palate, and the “risks for a cardiovascular defect and notably a cardiac septum defect were increased and statistically significant.”

In 2012, The Center for Birth Defects Research and Prevention published a study suggesting that women who used Zofran during the first trimester of pregnancy had a twofold increased risk of having a child with birth defects.

Although Zofran was not approved by the FDA for morning sickness, and despite studies linking the drug to birth defects, GSK continued to promote the use of its drug off-label.

READ ABOUT ZOFRAN BIRTH DEFECT LAWSUITS

Zofran Birth Defect Legal Help

If you or a loved one have suffered losses in this case, please click the link below and your complaint will be sent to a drugs & medical lawyer who may evaluate your Zofran Birth Defect claim at no cost or obligation.

READER COMMENTS

Posted by

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I'm sorry but although it is preferable to avoid medications that are unnecessary in pregnancy, you also have to consider that sometimes issues with a baby's development just occur for no reason. Developmental delay may be the result of a poor iodine diet, and things such as hearing loss may have just been bound to occur. Jaundice is very very common and babies I see often need phototherapy for treatment - they are otherwise fine. I think it's unnecessary to jump up and down about drugs if there is something wrong with your child as sometimes these awful things just happen, it is not your fault. Do your research on drugs that come from peer reviewed journal articles and along with your trusted Doctor, weigh up the risks vs benefits and see what is right. A person may do everything right in their pregnancy and have a baby born with hearing loss or a heart defect - you can always look at things negatively. For example, you could take no drugs, have a baby with a condition and say look NOT taking zofran caused the issue. It's all perspective and unfortunately it is common for many issues to occur as a result of environmental and genetic factors also. No need to try and sue a company over jaundice

Posted by

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My son is now 18 months old when he was born I noticed at 3 weeks old his head wasn't shaped right he we t to the doctors at 4 weeks he began therapy his doctor said his back was right which as he began his therapy his back was do e after 2 weeks but we had to continue to therapy with no change in his head shape it was his right side not the back after 6 months his therapist said nothing was Gerri g better so they sent me to a plastics doctor where he got a helmet he wore it for almost a year still no change in his head and also his right ear is big then the other his right arm is smaller then the left one and his for head goes in on one side he is always sick now he has hear I g loss in his right ear nose bleeds all the time they say its allergy and don't talk crys all the time and don't and still no dignoisis they just day all of this was caused from a stiff back at 2 birth and allergies

Posted by

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I took Zofran while pregnant in 2007 for nausea. My daughter is now almost 8 and has unexplained hearing loss in her left ear. She wears a hearing aid. Her right ear was deformed and we had plastic surgery on it when she was 5. I believe Zofran was the cause of her hearing loss. Law firms are not taking on cases with Zofran and hearing loss. I believe that hearing loss is way more serious than a physical defect that can be fixed by plastic surgery. Hearing loss is a forever problem that can not be fixed. It is also costly when my insurance doesn't cover hearing aids.

Posted by

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my daughter who is 2yrs old now, was born with a torn valve in her heart...when she was born she wasn't breathing correctly due to her heart defect. she was 2weeks old when she had heart surgery. after her surgery she was put on life support and passed away in front of my eyes. they revived her 5minutes later twice in a row. after 2mnths she was release home still having a few problems. i was always sick and vomiting whenever i was pregnant with her, more than i was with my first daughter and my son. i didnt have to take the medication for my other two kids . this is how i knew that something i took caused my babygirl to suffer all that pain . whenever i saw the commercial on tv about lawsuits against zofran, is when i found out that THAT was the reason WHY my miracle baby had to go through all of that! she was already born on the day of my mothers 2yr anniversary as a angel in heaven but the fact that she returned to me makes her my miracle even more!. for all mothers who have suffered the heartache of seeing their children having to go through unimaginable things i hope you all as well as i...get some type of justice for this! god bless all of you.

Posted by

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This is very wrong,I have called lawyer's that are only taking cases in which the child has heart problems or clip lip, what about the mothers that have to Be their child's care taker for the rest of they life Because of (gsk) misleading the public, I am so mad words can't even explain it.. I have 4 children in all I took this medicine while pregnant with him and he has a list of issues going on all of my other children are perfectly normal.. I just want to know why would you compensate some mothers but not all?????

Posted by

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I was Givin Zofran when I was pregnant in 2000. During my first sonogram I was told something was wrong with my baby's kidneys. When she was born she was taken to the nearest children's hospital at 2 weeks had surgery on her Kidneys and again at age two. I strongly believe it was the Zofran that caused this.

Posted by

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I found out that i was pregnant at about 4weeks so i started to have morning sickness.I couldn't eat or drink anything without it made me sick. After two weeks i checked into ER and the Doctor prescibe me Zofran.It did help a little but still couldn't eat but only drinks.I took it till I was 3 months pregnant and i went to see my obgyn and he told me when was my last menstrual period I answer 4/21/2015 and he check to the baby heart beat,and he told me maybe your baby is still too small for us to hear the heart beat and a month later i went for sonogram and my obgyn told me ur baby doesn't breath so he told me to moved to ultrasound room and thats when he told me that my baby was stopped growing at 12weeks baby was gone for a whole month but was still inside my belly and I was crying upset the doctor couldn't tells me why i lost my baby but after reading about zofran I believe that it could of been reason why I lost my baby.

Posted by

on
I took Zofran during both of my pregnancies in 2002 and 2004. My first daughter was born with ventricular septal defect and second was born with a congenital hearing defect. Luckily, my first never required surgery but constant follow up with a cardiologist. She had other multiple problems including jaundice etc. We did not know about my other daughter's condition until about 4 years ago. She now wears hearing aids. I like the others, would never have taken the drug had I known what effects it would have on my children. I have two beautiful girls who are thriving but very upset about reading this information.

Posted by

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I took the generic for Zofran and youngest was born with Jaundice he had to sit or even held with a blue light mat around him for two days, it was heart breaking. He has no other defects thank goodness. So not sure if this qualifies for a lawsuit at all.

Posted by

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On December 30, 2014 I delivered a 15.5 week baby boy due to intrauterine fetal death. The pathology report showed that he had a clubbed foot, abdominal defect and retracted leg. Although no actual cause was ever determined, I can't help but feel that Zofran was a factor in this loss. Not knowing why is a horrible feeling. He was cremated and I agree that picking up those ashes was the worst feeling in the world. After seeing the commercials and reading the studies on Zofran, I reached out trying to find if this drug caused this horrible loss. I've been told that all of his deformities are linked to Zofran use, but since he didn't make it to 27 weeks, we didn't have a strong case. Has anyone else heard otherwise or sought legal help?

Posted by

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I had twin boys July 22nd 2014. So a year old now. They were born with Craniosynostosis/Pfeiffer syndrome. Everything listed on TV they have. Not even a month old they had skull surgery. They have shunts put in to drain the fluid around thier brain. Tracheotomy tubes put in to help breathe. Feeding tubes. I'm currently going through a law firm that deals with Zofran cases and I've been told it takes a while it seems to be taking forever. About 6 months. If not longer. But with all that side. The courts have taken mine and the fathers parental rights and terminated them but its an open adoption. 2 hour visits twice a week. We went thru hell during the pregnancy and it only got worse after they were born. It hurts not having my boys.I don't wish any of this on anyone.

Posted by

on
I took Zofran with both of my children and both were born with tongue tie. Had the frenectomy for both asap. My first was great at feeding and my 2nd not as great. Her weight was low and so I ended up supplementing. I am currently pregnant and started taking 1 pill of zofran per day around 8 wks. I am now 11 weeks and feeling like I can stop.

Posted by

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I have taken the generic Zofran with all 3 of my children. I've never thought that this could have been an issue, but coming across this has me thinking. My first child had jaundice due to white blood cell disfunction and very bad breathing issue's. He was constantly taking medication for his breathing, and also saw a specialist for torticollis. My 2nd and 3rd child have also had very bad breathing issue's, my second seems to have overcome it. But my year old daughter is now set to see a breathing specialist. She has been on and off steroids for months and consistently heaping. Doctor's seem to think something may be wrong with her lungs. We will see, praying for the best! Shame on this company for false advertising and putting innocent lives in danger! We have the right to know of all possible side effects.

Posted by

on
Hi this was my 2nd pregnancy i was 11 weeks pregnant prescribed zofran in 2013 i was taken it till i was 4 months pregnant and ended up having a still born at 21weeks bleedimg through out i had to cremate my daughter due to the loss of her to know that now i know the cause of her death wich the doctor couldnt see its a relief but the loss of cremating your child and picking up death certificate and ashes is the worst feeling ever i hope and wish this upon no mother im still mentally hurt and as affected my life in so many ways

Posted by

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I found out I was pregnant at 8 weeks in 2007 I had sever morning sickness found out I was having triplets but I lost one for unknown reasons, both my boys were born with jaundice and one had a phnomothorax and only one is autistic which I hear is unusual for identical twins. I was givin zofran while in my first trimester and ended up continuing with it through out for morning sickness

Posted by

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My brother has autism and epilepsy. (excuse my spelling) Today we saw the commercial for Zofran. My mom was very sick while pregnant with him. I'm wondering if he got it because of it.

Posted by

on
I found out I was pregnant at 4 weeks because I was so ill from morning sickness. I couldn't keep anything down and thus was prescribed Zofran. The morning sickness lasted day and night for my entire pregnancy so I was taking the Zofran at least twice a day until he was delivered. At 20 weeks during our ultrasound we found out that we were having a boy. We have 2 girls already so we were extatic to find out he was a boy...
Then we realized there was something terribly wrong. Everything seemed fine until the techs started acting off. It was Spina Bifida. Talk about crushing when your doctor actually supports aborting your child. So given the choice we decided to continue! My son has undergone several surgeries for his back, bum, and head to combat all of the problems that come with Spina Bifida. I feel sick every time I think that all of his pain and suffering is due to me taking a prescription drug.

Posted by

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MY daughter is ten months old I was prescribed the generic brand of zofran for morning sickness in ny first trimester and took it quite often every four hours because I was very sick and couldn't keep anything down well when my daughter was born she. Was born with yellow jaundice and two heart defects partial seotial defect and also a PDA (heart murmur ) then when she was about six months old I seen an add on t.v. about the medication zofran causing those type of defects so I contacted a lawyer only for them to tell me that my case is on hold until there can be any lawsuits pertaining to the generic brand since then my daughter has had to have surgery because she was in heart failure and having trouble breathing we are still dealing with delays in her growth and we are still dealing with heart doctors and probably will for the rest of her life I believe that this medication is the blame and I will continue to warn every expectant mother just try to deal with the sickness because the medication isn't worth the pain of watching you baby struggle with breathing and heart problems and many sleepless nights its just not worth it

Posted by

on
I found out I was pregnant October 2011. I had really bad nausea and couldn't keep anything down. My doctor prescribed me zofran and I took it at least twice a day. Until I was about 4 months. They did an emergency c-section at 29 weeks and my son was kept in the NiCU for about two weeks when he was rushed to Mount Sinai to have an emergency heart surgery. He has a murmur, pinched valve also aortic stenosis. I've been watching TV and seen the commercial. He's going to be 2 on saturday.
I wonder if zofran could be the one to blame for this.

I called there number and said I don't qualify for an attorney. I need some answers.

Posted by

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I got pregnant with my son in 2011. I was having extreme morning sickness so my ob/gyn prescribed me Zofran I was 11 week at that time. The morning sickness subsided a little but I continued to take it as needed. At 20 weeks I went to my weekly appointment and eveything was fine, his heart rate was strong and he was developing and overall healthy at least thats what my doctor advised me. Two days later and still on Zofran my amniotic sac ruptured and I was rushed to the hospital. My son was still alive and many tests were ran to figure out what caused this to happen and they came up with no explaination. I was placed on bed rest to see Iif I could carry my son to at least 28 weeks so they could deliver my son. Sadly at 24 weeks and 2 days my son died and I gave birth to a stillborn baby. I cant help to think that Zofran is the cause of his demise since there is no other explaination. The doctor couldnt provide one. It has been almost four years and I still wonder why.

Posted by

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I was given zofran when I was pregnant with twins in 2011. The boy was born with premature lung disease and breathing problems. They have never slept through the night and also get frequent bloody noses. This is probably attributed to the zofran.

Posted by

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Hi,my fiance and I have a three year old daughter(actually will be 4 in may) that is experiencing the same things as Michelles son,our daughter experiences at least one bloody nose a day! She is also very very behind in speech, still talking baby talk and has a very hard time speaking the very few words she does speak!we have not received a diagnosis of cleft palate but we never thought to look into that because her lips and mouth seem normal to the naked eye.She is really behind in speech and we've been very worried about this!my fiance was taking zofran for morning sickness during our daughters pregnancy but I didn't notice these things until I just started reading up on zophran after seeing a commercial, I was curious if zophran had anything to do with the loss of our son even though his preganancy was three years after taking the zophran with our daughters pregnancy! about two and a half to three years after our daughter was born we got pregnant again and everything was fine with the pregnancy she didn't have morning sickness that bad just very exhausted most of the time and then when we went to go for our 20 week sonogram we found out that our son had major, previously unnoticed, congenital heart defects and it was so close to the 6 month mark that we almost ran out of time to make the decision to terminate or not, we were told by three different specialist that our son had less than 10 percent chance of survival and even with the 10% chance he would still go through 3 to 5 surgeries within the first 6 months of his life so we had to make the choice whether to terminate or not and it was a very very very hard decision for us but in the end we decided that we were not going to be selfish and take a child to full term that has less than 10 percent chance of survival given to us by 3 specialists! but once again I state the zofran was only taken during our daughters pregnancy 3 years before! I'm kind of wondering how long the defect gene stays in my fiance and if her taking zofran 3 years before with our daughter could have had an effect on our son three years later.and I also like to self I am wondering if the zofran is the reason for our daughters inability to form words even at almost 4 years old,and also if it's the cause for her daily bloody noses

Posted by

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I'm not sure if this is related but, I found out I was pregnant at 14+ weeks. Lost a twin that I didn't know there were two. My son is developmentaly delayed, has very high anxixety, and has never slept through the night without waking up screaming and he's 2 years old. I took generic zofran while I was pregnant one to two times a day in my second and third trimester sometimes everyday for weeks. Has anyone started researching the effects on these children? This pregnacy was the my first time taking zofran out of 3. Not sure if its worth looking into.

Posted by

on
My son was born with a vsd heart defect and had open heart surgery a week before he was 2 yrs old. I took zofran while I was pregnant and I regret it now finding out my child had to be cut on and repaired all the pain and suffering due to a drug prescribed. Just for a company to be greedy about money but not worrying about the harm for an innocent child. They will get whats coming to them. Thank u Levine Children Hospital in Charlotte NC and Thomas Maxey for fixing my baby boy heart. Thats the best hospital in nc if your baby needs surgery.

Posted by

on
I was prescribed zofran odt for severe morning sickness at 1 1/2 months pregnant. My son was born with tetrology of fallout, vsd, imperforate anus, Phocomelia of the right lower limb, vertebral defect, vactrel syndrome, poor weight gain, feeding problems, jaundice relating from liver problems. The leg and heart issues were things I found out when I was still pregnant. I'm just learning that he may not have a right hip and the whole right leg may have to be amputated. Surgeries includes : PDA (stint placed in heart) liver biopsy,anal stenosis, several MRI ct scans xray blood transfusions. The settlement will only be a very small short term compensation compared to what us mothers and family's are going to be dealing with for the rest of our lives because of someone else's negligence. My son will have to undergo countless surgeries to repair his heart and leg. Honestly, there's not enough money in world that this company (gsk)can pay me for the emotional mental and physical pain me my son and family have to deal with. Its not easy!!

Posted by

on
I took zofran due to extreme morning sickness in 2003. I found out at 18 weeks I was carrying twins - they were conjoined and shared one heart. I saw a number of specialists who all concluded that there was no chance for survival. I had a medical abortion at 20 weeks. I had two healthy children prior and 2 healthy children after, none of these pregnancies did I take zofran. Curious is anyone out there had a similar experience.

Posted by

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My son is 3 years old right now. The emergency room first prescribed me zofran when I was 5 weeks pregnant. I took it three times a day until I was about 24 weeks. He is my second child. My daughter which was my first was 100% healthy and I didn't take any medication at all. I also did not have any morning or all day morning sickness with her. With my son I was sick all day. When my son was 2 months old he had trouble swallowing and some delay in his development. He had therapists here 3 times a week up until he was 2 1/2. He had 2 different therapists coming to our home. Then he was sick in late November 2014 so I took him in the doctors office and thought I would start asking questions. So I told her he cant talk at all still baby talks. Maybe 20 words if that. Gets a bloody nose at least 1 time a day. So I thought maybe his muscles in his mouth were still weak that's what the therapists told me when he was an infant. Our family doctor said he needs to go see a specialist. So I took him December 4th 2014 and I heard the Bad news. That he has a cleft palate. I was shocked I never in a million years thought the doctor would say that. I didn't want to believe it so I called and made another appointment at another specialist and sure enough he said the same thing! Now our poor children have to suffer and be made fun of for the rest of their lives because of some company that wanted to make money and not care what could happen down the road. I am so sick to my stomach! I am so mad at myself because I would not have taken that medication if I would have known what could have happened to my poor baby! I would have suffered through the few months of sickness rather than a whole life time of problems for my son! I look at my poor child and get so frustrated because he can't tell me what he wants. I should be taking him to another speech therapist but I don't have a car right now that I can get him there. I didn't have anyone to help me out and give me a ride. I had a car but hit a deer and it had to be towed and the insurance will not fix it because I didn't have deer coverage. Now I have a son that has a birth defect for the rest of his life because of a medication that should go to the doctors so I can

Posted by

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I am posting this, due to Michelle's post, really... I got a suprise when I discovered in October 2013, that I was pregnant. I got SEVERE hyperemesis, to where I was admitted to the hospital for a week. Was given Zofran suppositories several times a day, then sent home with a script. This was AFTER their $3 billion settlement, that it was prescribed to me. I was on the med several times a day for several months, as I was extremely sick. Well, anyway, my daughter's growth had to be monitored the whole pregnancy, as they were worried about Fetal Growth Restriction. At one point, at my check up, her heart rate was not normal, and she was NOT reacting to ANY STIMULATION... Orange Juice, Rest, Loud noises, etc. I was in tears, and had to have an Urgent Ultrasound after monitoring for several hours, to ensure she was okay. I myself was sent to the ER several times, due to irregular heart rate. The baby was monitored closely during labor, and at one point, we almost had to have a C-Section, as they said her heart was not responding well to the contractions. She was born 5lbs, 11oz, full term. My third and smallest baby. She had low temp and low blood sugar, and I was not able to immediately bond/feed her because of this. About a day after birth, she was SEVERELY jaundiced, and had to be put under bili lights for several days, which FURTHER impeded on our bonding and breast feeding. Now she is 9 months, and her left eye ofter wanders, which for me is very scary. Her joints also CONSTANTLY pop, including her back, whenever trying to move her/pick her up, which for me is also scary, as i KNOW this is NOT normal for her to have joints that pop at her age. It is also almost IMPOSSIBLE to get her to take a nap for more than 10-15 minutes during the day, and she is VERY restless sleeper at night. I literally canNOT leave the room. I'm thinking that these problems may be due to the Zofran?

Posted by

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I took Zofran at 12-16 weeks, my child is fine, no problems. My morning sickness was so bad, I couldn't eat anything, I was so dehydrated I had not urinated in over 48 hours by the time I saw the Dr. So my question is: Is a woman who is prescribed Zofran for morning sickness more likely to have a fetus with problems because she takes Zofran or because she is more likely to be malnourished and dehydrated and the damage is done before she even takes the medication? My sister also had severe morning sickness throughout her pregnancy and just toughed it out, actually lost weight. Her son was born with torticollis and is developmentally delayed, has face and head malformation. You just never know.

Posted by

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I found out I was pregnant at about 2 months. About a week after I found out I started to have morning sickness. I couldn't eat or drink anything without it making me sick then when I didn't eat anything it made me sick. After about a week I went to my gyn doctor and she prescribed me zofran. It did help a little bit but still couldn't eat to much only a little at a time. I took it till I was four months pregnant. At four months I went for a sonogram and found out that I have lost the baby, the heart stopped at three months and didn't know for a whole month. At three months I was just starting zofran... I was devastated and after about 6 months today it still upsets me. The doctor couldn't tell me why I lost the baby but after reading and hearing about zofran I believe that it could of been the reason I lost the baby.

Posted by

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I started taking zofran 4 times a day my first trimester. While pregnant my son had full kidneys and they though he had down syndrom and offered the opportunity to abort we said no. They did a second ultrasound and said they didnt think he had it but didnt know. During my pregnancy I had severe heart issues and had to be monitored by cardiologists and had to have an ICU nurse monitor me during my labor. As soon as I stopped Zofran my heart gor better. I still have issues on occasion and not sure if its related. My son was monitored for his first few days and I couldnt feed him as he had blood sugar issues at birth. Hes developmentally delayed and nonverbal autistic. His heart rate goes up and down like a yoyo and I question weather or not he has kidney issues at this point. he had a frenectomy because he was tongue tied? it didnt work he was 6 when he had it done. it reattached and was a horrid experience for him. he also has sleep apnea. I am not sure if this is related to zofran and thought I woud message someone about it. Thank you

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