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#1 maria12345

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Posted 09 January 2008 - 03:49 PM

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If anyone had a baby with birth defects using zofran please contact me mwmexx @ gmail.com I received in the E.R. Ondansetron a serotonin 5-HT3 receptor antagonist used mainly to treat nausea and vomiting following chemotherapy and after surgery. There is little information about their effect on the pregnancy and therefore the standard advice is to avoid unless absolutely necessary. Evidence on the safety of 5HT3 inhibitors (such as ondansetron) in pregnancy is limited. I did not receive any information about this drug before using it on me, the doctor only said that it was an “unbelievable expensive antinausea medication”. Before I left the E.R. My husband questioned him about the drug. The assured him that this drug was not dangerous to my baby. I am sad because they injected me zofran without warning me about the lack of studies about the effects of this medication in pregnant women, especially in the first trimester. I am also upset because there are many mild and proven medications for treating nausea in pregnant women and they gave me a medication that is mainly prescribed for nausea and vomiting following chemotherapy and after surgery.We came to the hospital looking for relief and we trusted the doctors to make the right decisions. Some of the known side effects of Ondansetron include:· Slow heart rate (bradycardia)· Abnormal heart beats (arrhythmias)· SeizuresI did not presente any of those symptoms after the injection. However, I have no doubt that this medication affected my baby’s heart. The heart is developing its structures within the first 8 weeks and they injected me with Zofran at 7 weeks . It seems likely that a medication that has exhibited electrophysiological effects on the cardiac muscle in children and adults would affect the forming structures of my baby’s heart. My baby was born with a collection of very unusual heart problems. That unusual collection of heart defects cannot be probability only!!!!. Those problems according with medical literature are associated with an event happening in the first 8 weeks of pregnancy. Zofran was the only medication I took in my entire pregnancy. We learned about our baby’s birth heart defect at 14 weeks, and my husband and I chose to give our baby a chance at life, and not to have an abortion. I was very careful about taking care of my self throughout my pregnancy. I chose to give birth with a C-section because while this increased my risk, it lowered the risk to my child. I made many sacrifices to give my daughter her best chance at life. I would ever knowingly allow the doctors to give me this unproven medication if I had known how little was known about its effect on pregnant women. Do not allow that embryonic human life to be exposed to substances that might harm them and obstruct their normal development. Why whether this medication warns its use in children does not warn its use in pregnant women who carry little childs inside them? Why a package of cigarrets warns about its possible effects in pregnant women and an antinausea medication does not? This might not be of your concern, but my tears don't stop since then, and everytime I take my baby to the hospital. She had a heart surgery already and some more comming.


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#2 Ruttiebaby

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Posted 22 June 2009 - 08:42 PM

[size="3"][font="Century Gothic"]I have been pregnant three times. the first pregnancy I had morning sickness but since I was gaining weight the doctor did not give me any medicine for it. So I worship the Porcelain gods for 4 months. My son was born healthy. But my other two pregnancies I was on Zofran. Both my second son and daughter were born with a heart birth defect. My second son was born with VSD (layman's term hole in the bottom of the heart) and my daughter was born with an abnormal pulmonary value. It is crocked and "u" shaped. There has been no family history of heart birth defects on either side of the family and the doctors are not saying if there is a link. I believe ther is a link. How can one mothe who took Zofran be give birth to two children with a heart defect? i am looking for other families and mothers who have the same situation as I do to raise awareness to company that yes it does causes birth defects. I'm not in it for the money. I want to make sure other mothers do not have to go through what I go through. I have been blessed with the fact that their cardiologist is avoiding surgery and there has been some healing in their hearts. My daughter is currently not on any medication. My son is only on a diuretic. If you look at them you could never tell they have a heart defect. They have hit every milestone and act like normal. :(

#3 Guest_Glenda C._*

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Posted 23 June 2009 - 09:10 PM

I was deathly naused the entire 9 months of my pregnancy. Non stop vomiting.The doctor gave me some kind of an anti nausea medication , damned if I can remember the name , that was 27 years ago.But guess what , My sweet little boy was born with Mitral Valve Prolapse.He's 27 now.Thin and frail. No energy to do anything. Pail as a ghost. Sleeps most of the time when he can. Looks very ill when he's not.At times his heart pounds so hard in his chest he will pass out.The stupid Gyn. doctor is retired now.About 20 years ago.I wish I had access to my records.I bet it was this medication your speaking of.Is there legal recourse ? If we were on this medication who would we sue's ? The doctor ? The drug manafacturer ?This is terrible.

#4 Christian with a thorn

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Posted 23 June 2009 - 09:31 PM

Oh my Gosh! That is too much of a coincidence you guys. I would definetely pursue this. I was put on an anti-nausea med. a for a short time my first trimester, but it was called Reglan. I am hoping there is not relation. I am almost 7 months along now. Good luck to all of you, and I hope you get the answers you're looking for.
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#5 Kathleen M.

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Posted 24 June 2009 - 05:25 AM

Zofran was approved in 1991 so if you took meds for nausea before that date it wouldn't be it.http://en.wikipedia....iki/OndansetronThey almost never test any medication on pregnant women because it is too risky. On the other hand a drug free pregnancy does not ensure your baby will be born perfect. There are lots of errors in development and often it is hard to tell what is just something that happens anyway and what might be caused by a medication.Like most drugs it has had some testing in pregnant animals and in those it does not cause birth defects or impair fertility (and usually those are at a much higher dose). If you will only take drugs with adequate testing in pregnant women vs those tested in animals you will have a very short list of things to try. Starving to death because you can't eat anything from nausea isn't particularly good for the baby, either. Sometimes they do have to make sure you and the baby can survive and that may mean they take certain risks with medications that do not cause problems in animals (and sometimes even with a few that are known to cause defects in humans but the risk of not surviving is higher than the risk of damage)
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#6 Guest_Glenda C._*

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Posted 24 June 2009 - 09:04 AM

I got pregnant in 81 and had my son in mid 82.So maybe this wasn't Zofran then if it came out in the 1990's.How on earth did my son get Mitral Valve Prolapse ?Gezzz , I wish I had access to my old records at the Gyne office.Then I could see what he put me on for about 1 month.The stuff didn't work so he took me off of it and told me just to drink flat 7 up. or Pepsi.That was a joke too. Oh well.

#7 Kathleen M.

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Posted 24 June 2009 - 04:07 PM

It seems to be something some people are just prone to more than only caused by this one drug during pregnancy.

The mitral valve prolapse (MVP) syndrome has a strong hereditary tendency, although the exact cause is unknown. Affected family members are often tall, thin, with long arms and fingers, and straight backs.

http://www.medicinen...pse/article.htmIt looks like from a couple of papers that it depends on what genes you get for connective tissues as that is what the valve is made of. It ranges in severity from people who don't notice anything to very severe as well. While sometimes a specific drug causes a specific defect but most of the time stuff like this is which genes you have and how the parts happen to grow and some people's parts get made in a way they don't have problems with them and some people have problems with any given part.
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#8 Glenda

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Posted 25 June 2009 - 08:44 AM

No one in my family Has , or Had heart conditions of any kind.The same goes for my Husbands family.Yes my son is tall , thin , long fingers, arms and legs and toes.That is a sign of MARFAN Syndrome.My son went for lengthy testing for that.He does Not have Marfan.I have longer fingers and toes , Not arms or legs. I am short 5.3.I don't have Marfan.I guess it was just a fluke of nature that my son was born with MVP.Could it have been that anti nausea med the Gyne put me on ??? I honestly don't know , as I don't know the medication name.I wish I did. The doctor retired over 20 years ago and not having access to the old records I just can't say wether or not the drug could have contributed to his MVP.If it did , Oh boy would I be mad as a wet hornet.

#9 Kathleen M.

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Posted 25 June 2009 - 09:30 AM

You can have the body type without having Marfans, and it didn't say you have to have Marfans.MVP sounds more like a connective tissue difference, not standard issue heart disease like heart attacks from clots or electrical issues.Which set of connective tissue genes you get can influence how the bones and joints grow (and when really screwy cause Marfans, but there is a range) as well as how parts like valves in the heart get made.For a lot of these things there are several genes (or the genes are recessive) and it depends on what combination you got. So somethings may skip several generations or only show up if you mate with someone that also has some of those genes from several generations back.
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#10 Mother Hubbard

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Posted 21 July 2012 - 08:15 PM

If anyone had a baby with birth defects using zofran please contact me mwmexx @ gmail.com I received in the E.R. Ondansetron a serotonin 5-HT3 receptor antagonist used mainly to treat nausea and vomiting following chemotherapy and after surgery. There is little information about their effect on the pregnancy and therefore the standard advice is to avoid unless absolutely necessary. Evidence on the safety of 5HT3 inhibitors (such as ondansetron) in pregnancy is limited. I did not receive any information about this drug before using it on me, the doctor only said that it was an “unbelievable expensive antinausea medication”. Before I left the E.R. My husband questioned him about the drug. The assured him that this drug was not dangerous to my baby. I am sad because they injected me zofran without warning me about the lack of studies about the effects of this medication in pregnant women, especially in the first trimester. I am also upset because there are many mild and proven medications for treating nausea in pregnant women and they gave me a medication that is mainly prescribed for nausea and vomiting following chemotherapy and after surgery.We came to the hospital looking for relief and we trusted the doctors to make the right decisions. Some of the known side effects of Ondansetron include:· Slow heart rate (bradycardia)· Abnormal heart beats (arrhythmias)· SeizuresI did not presente any of those symptoms after the injection. However, I have no doubt that this medication affected my baby’s heart. The heart is developing its structures within the first 8 weeks and they injected me with Zofran at 7 weeks . It seems likely that a medication that has exhibited electrophysiological effects on the cardiac muscle in children and adults would affect the forming structures of my baby’s heart. My baby was born with a collection of very unusual heart problems. That unusual collection of heart defects cannot be probability only!!!!. Those problems according with medical literature are associated with an event happening in the first 8 weeks of pregnancy. Zofran was the only medication I took in my entire pregnancy. We learned about our baby’s birth heart defect at 14 weeks, and my husband and I chose to give our baby a chance at life, and not to have an abortion. I was very careful about taking care of my self throughout my pregnancy. I chose to give birth with a C-section because while this increased my risk, it lowered the risk to my child. I made many sacrifices to give my daughter her best chance at life. I would ever knowingly allow the doctors to give me this unproven medication if I had known how little was known about its effect on pregnant women. Do not allow that embryonic human life to be exposed to substances that might harm them and obstruct their normal development. Why whether this medication warns its use in children does not warn its use in pregnant women who carry little childs inside them? Why a package of cigarrets warns about its possible effects in pregnant women and an antinausea medication does not? This might not be of your concern, but my tears don't stop since then, and everytime I take my baby to the hospital. She had a heart surgery already and some more comming.



#11 Mother Hubbard

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Posted 21 July 2012 - 08:37 PM

I had a daughter 12 years ago after being prescribd Zofran and she was born 3 weeks early in repsiratory distress. The Dr.'s initially thought she had a genetic syndrome and told me to prepare for her death! 11 days later she came home with her family saying goodbye to the NICU (Newborn Intensive Care Unit). My daughter has since undergone 10 surgeries to correct the abnormalities she suffered a a result of my Zofran prescription. My daughter was initially born with some heart problems such as atrial stenosis and a heart murmur; though these symptoms subsided by age 5, thank God! However, my daughter was also diagnosed with a diaphragmatic eventraion (an elevated diaphragm which allowed her liver to enter her lung, making it harder for her to breathe) because of this she had to undergo a thoracotomy at 8 months! My daughter also had surgery to correct her webbed toes, ingueno hernia's, and hearing loss. She has learning disabilities, speech delay, and hearing loss to name a few! You ARE NOT ALONE! Just today, I found at least 10 OTHER STORIES ON THE WEB! Two days ago a friend sent me some links which I posted on a newly created page on facebook called (MAZ) Mother's Against Zofran Birth Defects. I have spent years doing research, petitioning, contacting my state legislators, the mayor of Massachusetts, the FDA, The US Attorneys Office, and recently I spoke with someone at The Office of Health and Human Service in my state! One of my friends took Zofran and all of her daughters organs are in the wrong place and she has no spleen. I have been contacted by 4 other women online with the VERY SAME suspicions. The problem is MOST patients DO NOT KNOW the process of reporting "adverse reactions" to the FDA by way of a form called MedWatch. Once parents report their information concerning their child then the FDA will be put on notice; until then we will continue to read more unfortunate stories such as ours. Please email me with any questions or concerns as I have been yelling, kicking, and screaming for the last 12 years, even when it appeared I was the only one! I urge ALL parents whose children were born with abnormalites to contact the FDA and if they are interested they may request a copy of the 20+ page "adverse reactions reported list" on Zofran from the FDA via a FOIA (Freedom of Information Act) for free! I have monitored those reports and over the years they have grown. It doesn' take rocket science to put this together. NONE of us would have taken this drug had we known its harmful effects to our children! The FDA has recently placed a black-box label on Zofran regarding it's 32mg dosage to Chemotherapy and Leukemia, and Post-op patients because it has been shown to cause HEART PROBLEMS! Initially, I don't believe the medical field was aware of the side effects of Zofran during pregnancy; because even the midwife who prescribed it to me had a child prematurely, low birth weight, and failure to thrive; though it didn't help her to assist me in stopping it from being prescribed. Recently, GSK Glaxo Smith Kline, the makers of Zofran, settled a 34 Billion $ settlement for Medicaid fraud, hiding negative study information/data from the FDA, knowingly peddling Welbutrin to teenagers for depression; despite it's homicidal and suicidal side effects, and I'm certain we have all read or heard about the faulty Paxil pills it maufactured until one of their very own employees blew the whistle on them. The mothers of children affected by Zofran must come together against a billion dollar pharmaceutical conglomerate to prevent other children from being harmed. Like many other mothers I have voiced m opinion on this and even been looked at strangely, or worse; but the mothers AREN'T LYING, or making it up. The use of Zofrasn within the medical field is atrocious! In 2007, after it cause my daughters medical problems, she went in to the hospital, for a small dental procedure; during the pre-op meeting, I met with the anesthesiologist to discuss antinaseau meds. We agreed she would not be given Zofran; though her patient rights were violated and she was AGAIN gven the drug! To thisdate I have that letter of apology from the anesthesiologist on a LARGE POSTER where I keep ALL my other Zofran related material pertaining to my daughter. Please feel free to contact me at tommyleclair@yahoo.com as I would love to join together and uncover the ery truth WE have been speaking about for years!

#12 Mother Hubbard

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Posted 21 July 2012 - 08:41 PM

[size="3"][font="Century Gothic"]I have been pregnant three times. the first pregnancy I had morning sickness but since I was gaining weight the doctor did not give me any medicine for it. So I worship the Porcelain gods for 4 months. My son was born healthy. But my other two pregnancies I was on Zofran. Both my second son and daughter were born with a heart birth defect. My second son was born with VSD (layman's term hole in the bottom of the heart) and my daughter was born with an abnormal pulmonary value. It is crocked and "u" shaped. There has been no family history of heart birth defects on either side of the family and the doctors are not saying if there is a link. I believe ther is a link. How can one mothe who took Zofran be give birth to two children with a heart defect? i am looking for other families and mothers who have the same situation as I do to raise awareness to company that yes it does causes birth defects. I'm not in it for the money. I want to make sure other mothers do not have to go through what I go through. I have been blessed with the fact that their cardiologist is avoiding surgery and there has been some healing in their hearts. My daughter is currently not on any medication. My son is only on a diuretic. If you look at them you could never tell they have a heart defect. They have hit every milestone and act like normal. :(



#13 mommy27

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Posted 22 July 2012 - 07:02 PM

I was sick throughout my entire pregnancy and worse for months after birth. I dropped from a size 13 to a size 0. I took reglan, then several things I dont recall the names, didnt work, and finally zofran thru iv pump, because insurance would not pay for the pill. I developed huge painful welps on my body from the medical tape used to hold the iv in place so I only took zofran for two weeks before stopping all medication. My daughter was born 4 days late with two heart murmurs found at the age of 3 from a new pediatrician. For 3 yrs, a team of peditricians never found that. I wasnt happy with their medical approach to anything so I swopped. The new doc found it on our first visit for a skin rash. Anyways, my husband was born with a heart murmur so I cant say what caused them. We were told she would not grow out of them as they say, and she would be more subseptible to heart disease later on in life because of that. However, I believe in God Almighty, who heard my prayers and the doctors are still in shock of why they cant hear the irregular heart beat anymore. They say, its just moved to where they cant easily detect it but seriously two moved? Uh, no! God answered my prayers! She is perfectly healthy and very smart for a 5 yr old. I hate all of you parents who are dealing with heart defects of your children. although ours wasnt as serious as most, but at first all we knew was she was being sent to leboneur childrens hospital to check her heart. At that moment, the fear of the unknown strikes and you wonder why it just cant be you? Why does an innocent child have to have heart problems? Like I said, im very sorry for what each of you are going thru. I do not know if the medication was the cause, considering I only took it for a short time. But when I took it, it was a last resort at saving both our lives. I would black out from malnutrition. Thank God people around me knew this and caught me everytime. I could of landed on my stomach or hit my head, Lord knows what. I lost 18 lbs in the first 3 months and a total of 30 something being pregnant then much more after birth. I couldnt afford not to take it zofran. For two weeks, I kept down food, my baby grew in that short time, and being sick for 7 months already, I needed nutrients. She needed nutrients. So the benefits outweighed the risks in my case. Her heart murmurs never affected her life. if zofran causes defects, yes I believe it should be pulled but after 4 antinausea meds during my pregnancy, that one was our last hope. I would have continued to take the pill if insurance had opted to pay for it. But I guess after ready this, i thankful the insuramce company were cheap skates.

#14 Aussiemum

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Posted 14 August 2012 - 06:39 AM

I have a 10mth old daughter. After so many hearing tests it is confirmed she has a mild but permanent hearing loss in both ears and we will fit her with hearing aids next month. I had hyperemisis in my first pregnancy (constant vomitting) and was put on iv drip for a day, un be known to me it also contained zofran which my husband and I specifically had asked not to take. The zofran left me more sick then I was to begin with and did not aid my vomitting. I never took it again and just used maxalon which i understand is very safe. I read that zofran gives heart defects so when we passed the 20 week scan I thought we were in the all clear I never thought my child would have a hearing defect. There is no known cause for my daughter's hearing loss however I am becoming very suspicious of the zofran. I am now 9 weeks pregnant with baby no. 2 and have hyperemisis again. I refuse to take any drugs at all this time. I would be very interested to know other people who have had problems with zofran.

#15 Dora p

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Posted 14 February 2014 - 09:59 PM

I am contacting you because I'm pregnant and I was prescribe zofran jan 30 2014 and I have taking it a total of 8 times between then and Tuesday February 11,2014 and I grew suspect of it because my heart started to beat fast and it felt like my womb was numb. I haven't has a ultrasound to hear the heart beat yet but I was wondering is this going to effect my baby. I am 8 weeks 6 days.

#16 Kathleen M.

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Posted 14 February 2014 - 10:13 PM

A study of 600,000 woman says it won't harm the fetus.

 

http://www.huffingto..._n_2776753.html

 

If you are having unusual symptoms during your pregnancy please contact your doctor immediately.


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#17 Dora p

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Posted 15 February 2014 - 06:42 AM

No harms were seen from Zofran use, which occurred in 1,970 of the 608,385 pregnancies. The study looked at birth defects collectively, and cannot rule out a higher risk of specific ones, although the incidence of those is very small, researchers noted. The Danish Medical Research Council paid for the study. So what happened to the 606,415 other? That a huge number

#18 Kathleen M.

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Posted 15 February 2014 - 07:37 AM

I could go pull the actual paper, but often for some things you need a very large cohort of women to get the background rate.  If you only study women who took the drug and don't know the rate in other women (who did any number of other things) you don't really know if the drug did anything.  Let me go see what I can find of all the other results other than the headline one.

 

And as they said, if you are vomiting to the point you cannot possibly provide adequate nutrition for the fetus, we know that causes problems with development.

 

ETA.  So this is a cohort containing a huge number of pregnancies they can use for data mining.

 

They needed a huge number go get enough women with exposure to Zofran to get statistics.   Each of the exposed pregnancies (woman who took the drug) was then matched with four unexposed pregancies from teh cohort (all women meeting the criteria in the national registry in a certain time period) so the unexposed women matched for a variety of things but were as similar as possible in this group to things like age, common diseases, weight, number of prescriptions during pregnancy.

 

So the comparison group was a subset of the larger cohort and to get the matched set you need a lot of people to sort through.

 

Would be nice to have a double blind placebo controlled study, but letting women vomit uncontrollably may not be ethical.

 

There doesn't seem to be a reason to think that in that data set they had anything other than the usual number of normal births and birth defects that you see in any other data pull.  Do you have any other concerns about Danish women doing whatever is the standard medical practice there?  Now I don't know the stats of the top of my head to know if they got more prescriptions or less than US women, but for all the various things pregnant women are exposed to, adding Zofran didn't seem to be a major risk, with the caveat you may not find the increases the risk from 1 in a million to 5 in a million in a group this size. 

 

The biggest difference I saw is that the unexposed women who otherwise matched the exposed population had a higher rate of use of other anti-nausea drugs.  Because like I said letting women vomit so much they may effect the fetus isn't good.

 

I know we all say no pregnant woman should ever take anything ever, most women are exposed to something during pregancy because just letting all the bad things that can happen if you do nothing to protect the health and well being of the mother.  Development is a pretty delicate thing and it often goes wrong even when there is no particular exposure to something.  There of plenty of reports of birth defects (obvious visible ones as well as babies just dying in the day or two after birth) in the ancient medical lit before the age of industrial chemicals and prescription drugs.  Sometimes I find it a miracle any of us are born with the right number of parts given how many things have to go right during the pregnancy.


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