Zofran linked to birth defects

lsno · February 2015

I've been taking Zofran my whole pregnancy for nausea and lately there has been a lot of talk of it leading to birth defects such as cleft lip and palate and heart problems. I talked to my doctor and she said its a bunch of crap basically. But then my cousin told me her friends baby had a cleft lip because she took Zofran, and she wasn't lying. Super paranoid!! Help??? :-??

Leahauc · February 2015

I highly doubt it. Lots of women take zofran during pregnancy, just because babies are sometimes born with a cleft lip doesn't mean it has anything to do with the zofran. Babies will still be born with cleft lips even if zofran isn't prescribed. I'm with your doctor on this one.

k3taeko · February 2015

I agree with your doctor. If she prescribed it to you, it's because it is safe. I take Zofran as well for my pregnancy nausea and have absolutely no worries.

ipumpkin · February 2015

My cousin just had a baby with a cleft lip. I don't think it happens because of the Zofran, I think it happens because that's just how it is....

agt104 · February 2015

Cleft lip is a genetic condition and not affected by Zofran. My sister took it for both her pregnancies and her kids are fine! Dr. knows best they have much more experience then one person. When something goes "wrong" in a pregnancy people like to blame. A cleft lip is easily fixed and you would know about it by now (the scans should show the lip is not growing together correctly). Take a deep breath and keep taking your Zofran, your baby needs the food!

Cocoasushi · February 2015

Cleft lip and palate is a neural tube defect which happens in the first few weeks of pregnancy, usually before moms even know they are pregnant and before they've seen their doctor or started taking zofran or even tums for nausea and morning sickness. I've had three pregnancies, one of which was to a little boy with spina bifida, also a neural tube defect that he developed before I even knew he was there. I've had a friend have a son with a bilateral cleft palate and lip. Both of our sons problems with due to folic acid definitely (doctors said my weight was to blame for my deficiency and her cigarette smoking caused hers) Given my sons diagnosis in my previous pregnancy, my doctor was still confident prescribing me zofran. I wouldn't worry too much about the chatter about birth defects

grlplz · February 2015

This is my 3RD pregnancy and I've been prescribed Zofran for all of them and there haven't been any problems. Doctors know better than people's friend of a friend, if there was any kind of question they'd at the very least warn you.

Mamamads · February 2015

I was just reading up on this. It's true. And just because it's prescribed often does NOT mean doctors know it's 100% safe,
Many things were commonly used and then found to cause birth defects. If you are still taking it stop and don't worry about what's been done already because you can't change it.
I will add this is newer information which is why this medication is still given, I'm sure once it's 100% conclusive that it could be harmful it will no longer be prescribed.

Mamamads · February 2015

agt104 said:
Cleft lip is a genetic condition and not affected by Zofran. My sister took it for both her pregnancies and her kids are fine! Dr. knows best they have much more experience then one person. When something goes "wrong" in a pregnancy people like to blame. A cleft lip is easily fixed and you would know about it by now (the scans should show the lip is not growing together correctly). Take a deep breath and keep taking your Zofran, your baby needs the food!

This is terrible advice. Look up thalidomide.. Something that was once commonly prescribed to pregnant women and lead to TERRIBLE birth defects. Just because something hasn't proven to be harmful or isn't common knowledge to be harmful does not mean it isn't. And your sister having two healthy babies isn't proof it is safe. I'm not sure how new of a drug zofran is but I was readig several articles yesterday about it being linked to birth defects some MUCH worse than a cleft lip, like heart issues etc. So I think people taking this should be concerned and see if the benifets out way the risks.

dreinhardt · February 2015

They will be able to detect a cleft lip and some heart issues during your anatomy scan if that makes you feel better. I don't think defects are linked to Zofran. If there was a link, it wouldn't be prescribed or used.

ThisMakes5 · February 2015

https://www.fertilitycenter.com/fertility_cares_blog/fda-warns-against-zofran-use-in-pregnancy/

The FDS is now warning agianst it.

Just because a doctor says something is safe doeant ALWAYS mean they are corrwct, or even know that it may not be.

This is not to scare anyone into not taking it, just to caution people to do a little research. We ALL have opinions in life and we are not always going to agree.

If you have concerns about medication talk to you Dr. I always research print out things I find and then take them with me. Getting a second opinion never hurts!

agt104 · February 2015

@mamamads Wow... Many other people had the same advice as me....attack others much???

Also I am wondering if you got your Ob degree online since clearly all the information here is to be taken at truth.

to the OP take your Doctor's advice they do know best....

Mamamads · February 2015

agt104 said:
@mamamads Wow... Many other people had the same advice as me....attack others much???

Also I am wondering if you got your Ob degree online since clearly all the information here is to be taken at truth.

to the OP take your Doctor's advice they do know best....

It's not an "attack" so settle
Down. If your reasons for something being safe are "someone I know took it and they/their kids are fine" that is terrible advice and I'm going to tell you so. If you check out the link someone posted right above you, you will see medical opinions are changing on the safety of this drug. Medicine is constantly evolving, something that was once safe etc can change to not be after it's been used
For a few years so just because a dr prescribes it doesn't mean it's always safe. Yes she should definitely talk to her doctor and not take advice from Internet strangers.

masabmom · February 2015

I get that you feel nervous when you hear a story while pregnant. I think I would talk to my pharmacist, they would be able to give you any information you need. It's a quick phone call that can ease your mind and ask if there is something else you could have the doctor prescribe.

k3taeko · February 2015

So I just saw the bad drug commercial and now Zofran is on it and to call if you took it during your pregnancy and your child ended up with a birth defect.

If you are still worried, stop taking it and call your doctor to talk to her about it. Let her know your concerns. That's a part of what she's there for aside from making sure to help you have a healthy pregnancy.

grlplz · February 2015

I just read the FDA warning and it states that they are NOT saying doctors should stop prescribing it or that patients should stop taking it. They are warning people while they investigate the claims that there is a link. They want you to talk to your doctor about any questions you have or if you are concerned and would like to stop taking it.

I will say if you do stop taking it get in to see your doctor as soon as you can so that you can come up with a "plan B". I get how scary it is to hear this news and I am not telling you what to do either way as I am not a doctor, but I am one of those people whose body responds to pregnancy in a negative way. I have had HG with all three of my pregnancies so I get what you are going through for your doctor to prescribe the drug. So don't just stop taking it a grin and bear it. Work with your doctor to figure out another way for you to survive these 9 months!

grlplz · February 2015

https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm351864.htm

kelckings · February 2015

If you'd like to do some of your own research, Google scholar has lots of studies done all over and will give you some answers. I just did a research project on this topic for a class I'm taking for work and I found that there is no conclusive evidence. Just because someone has had a cleft lip child while taking Zofran doesn't mean it's related and lots of peoples babies are born with cleft lip who had never taken zofran. Read a few studies on a site that explains how the research was done (randomized trial, control groups, etc) to help ease your mind. If you find something alarming, show your Dr. Just remember, baby does need food! But definitely look it up. Google scholar is a good resource for the public. Also, your local library probably has a database with studies too:) good luck!

anicsmith · February 2015

This is something I've been reading up on as well. I saw the commercial last week and made the decision to lay off of it until I speak to my doctor. I think that opinions are great, but when it comes to a life growing inside of you, it's best to be informed instead of basing future outcomes on the successes or mishaps of others.

shaley29 · February 2015

There is a class action lawsuit against them. This doesn't necessarily mean that it's true, like the fda said they have to research it. But obviously it isn't saying it isn't true either. I personally would not take the risk unless you are in dire need, like losing so much weight, baby is growing slow etc.

JHaworth84 · February 2015

Mamamads said:
I was just reading up on this. It's true. And just because it's prescribed often does NOT mean doctors know it's 100% safe,
Many things were commonly used and then found to cause birth defects. If you are still taking it stop and don't worry about what's been done already because you can't change it.
I will add this is newer information which is why this medication is still given, I'm sure once it's 100% conclusive that it could be harmful it will no longer be prescribed.

@Mamamads‌ I agree there is no scientific evidence to say Zofran is safe in pregnancy and there probably never will be due to the ethics of research on pregnant women. The only evidence we have is from observation over time so it is true that new risks can emerge. However I don't feel you should tell someone to discontinue their medication- you are not her doctor and don't know the indications for the medication or her past medical history.

I am a doctor in the UK and take Zofran (well the generic Ondansetron, cheaper but essentially the same) for hyperemesis. It is very difficult to get treatment for HG here in UK due to doctors being very cautious prescribing in pregnancy due to lack of hard evidence and fear of litigation. I am surprised so many ladies here are on Zofran and makes US prescribing seems far more liberal, but for me the benefits outweigh the risks and I'm sure lots of mums on here feel the same. Please don't make mums feel guilty as HG is really a miserable condition and for many we have no choice xx

ThisMakes5 · February 2015

This is in responce to the above post about medication being more liberaly given and NOY ABOUT PREGNANT WOMAN!!!

In america they show commercials for medication so people can self diagnos and then talk to their doctors about medications they think they should be on. It a huge problem I believe and it leads to problems allthe time! Doctors get kick backs from drug ccomepanies for perscribing medications and I honestly feel that many give people what they want at times as sad as it is.

Most people in general want an easy fix, they do not want to hear thst if they stop eating two bags of chips a day and get up off the couch they will start feeling better. They want the doctor to give them meds to help them lose weight while sitting on the couch eating the chips.

Americans are lazy.

mers90 · February 2015

Hello, I live in Mexico and I've never heard of anyone taking it during pregnancy, it is a medicine for cancer patients going through quimo. I read a couple of links about it and here it is NOT recommended during pregnancy. I still have terrible nausea and took something called "bonadoxina" for a couple of months, but I stopped because I prefer to avoid as many meds as I can while pregnant! I learned that eating some yoghurt first thing in the morning and also always having something sweet around (like orange tic tacs) helps me with my nausea! Not everyone's the same but you could try different foods and see if anything works. With my son I had to eat tangerines all day long.

mers90 · February 2015

Oh and btw, you don't need a prescription to buy it here and even then no one takes it during pregnancy.

Lulamae123 · February 2015

Any medication for sickness during pregnancy I would be skeptical of. Look at the Thalidomide babies. I don't even like taking tylenol I only do when necessary. Doctors are not medication specialist. They don't always keeps up with the new studies. I had meds for period cramps and y doctor overdosed me by 125mg thankfully my pharmacist caught it! I always get my pharmacist to double check everything. Doctors can be wrong.

Mamamads · February 2015

JHaworth84 said:

Mamamads said:
I was just reading up on this. It's true. And just because it's prescribed often does NOT mean doctors know it's 100% safe,
Many things were commonly used and then found to cause birth defects. If you are still taking it stop and don't worry about what's been done already because you can't change it.
I will add this is newer information which is why this medication is still given, I'm sure once it's 100% conclusive that it could be harmful it will no longer be prescribed.
@Mamamads‌ I agree there is no scientific evidence to say Zofran is safe in pregnancy and there probably never will be due to the ethics of research on pregnant women. The only evidence we have is from observation over time so it is true that new risks can emerge. However I don't feel you should tell someone to discontinue their medication- you are not her doctor and don't know the indications for the medication or her past medical history.

I am a doctor in the UK and take Zofran (well the generic Ondansetron, cheaper but essentially the same) for hyperemesis. It is very difficult to get treatment for HG here in UK due to doctors being very cautious prescribing in pregnancy due to lack of hard evidence and fear of litigation. I am surprised so many ladies here are on Zofran and makes US prescribing seems far more liberal, but for me the benefits outweigh the risks and I'm sure lots of mums on here feel the same. Please don't make mums feel guilty as HG is really a miserable condition and for many we have no choice xx

I agree and also agree nobody should be saying to keep taking it and that they are fine doing so. As I said in a different post speak with your doctor and see if the benifets outweigh the risks as should be done with any medication. If you could change what you are eating and when you are eating it vs taking a potentially harmful medication why not start there. Americans are definitely all about the magic "pills" which is sad. Not trying to make anyone feel guilty but this information is new to me and if this came to light on something I was regularly taking I would want to know about it.

JHaworth84 · February 2015

I don't think anyone who can manage their sickness by dietary changes and rest alone should be on medication- that is normal nausea and vomiting of pregnancy and not HG.

@mers90‌ It is true that the drug was developed as an anti-emetic for chemotherapy induced vomiting and in the UK it is only licensed as such, however it is also widely used (off license) for post operative nausea and vomiting and as second line therapy for HG (under specialist obstetric advice only).

JHaworth84 · February 2015

@ThisMakes5‌ I wouldn't go as far as saying 'Americans are lazy' that's a bit of an extreme conclusion (and probably offensive to like 99% of mums using this forum?). It does concern me that doctors may be influenced by financial gain in a private healthcare system, although I would hope most are guided by patients best interests first and foremost assuming they take the same Hippocratic Oath we do in the UK.

ThisMakes5 · February 2015

I think most americans and moms on the board know what I mean when I say Americans are lazy

it wasnt to offend anyone.

grlplz · February 2015

JHaworth84 said:
I don't think anyone who can manage their sickness by dietary changes and rest alone should be on medication- that is normal nausea and vomiting of pregnancy and not HG.

Thank you! Anyone who has or had true HG gets it and understands how hard it's going to be if this medication is not safe to use. I am so sick of hearing, try changing what you eat, take prenatal at night, it's all in your head, blah, blah. If that were true I wouldn't have HG!

tizzie25 · February 2015

I ended up with a zofran pump administered through a PICC line 24/7 for a month when I was pregnant with my daughter. I had HG and could barely function. Even after the PICC line was removed I took a zofran pill every day til the day she was born. I was miserable! This time around I took a zofran pill (or 2) every day in the first trimester just so that I could function enough to take care of my daughter.. I am doing much better now and only feel the need to take one once a week. My daughter was healthy at birth and has had no major health concerns.

JuneBug0611 · February 2015

shaley29 said:
There is a class action lawsuit against them. This doesn't necessarily mean that it's true, like the fda said they have to research it. But obviously it isn't saying it isn't true either. I personally would not take the risk unless you are in dire need, like losing so much weight, baby is growing slow etc.

There was also a class action against the company that made Diclegis (when it was called something else back in the 70s) and it was subject to an FDA warning and yanked from the market with the exact same concerns of correlation with cleft lip and heart defects.... and now it is back as the nausea medicine of choice recommended by the FDA.

The information about Zofran is new-ish (1.5 years old) but not so new that most OBs haven't heard of it. I spoke at length with my OB about this early in my pregnancy because I was on Zofran my whole pregnancy with DD and this warning came out later and I was worried about this LO. We had a great conversation about it and he convinced me that this is a weak link and Zofran is still quite safe and well worth the risks for someone like me who has borderline HG.

Still I tried Diclegis first this pregnancy. It didnt stop my vomiting and it made me feel like a zombie unable to do my job which my family depends on for survival. So I am back on Zofran. Everything looked good in my anatomy scan and I am comfortable with my decision.

It certainly is alarming when the FDA issues a warning about a drug you are taking and it is definitely something to talk about with your doctor, but then you just need to make the best choice for you, that you can live with.

JHaworth84 · February 2015

Here in the UK you wouldn't be able to file a legal claim against the drug companies as the drug is not license for use in HG. You could only seek legal action against the prescribing doctor, hence the reluctance for doctors to prescribe it.

@grlplz‌ Sorry you are having a miserable time, it is something that is definitely poorly understood or appreciated. Considering I am a doctor working with a bunch of other doctors and nurses I have had very little empathy in any of my pregnancies, mostly just bitching that I've had to take quite a few weeks off work in early pregnancy! Now everything is much more controlled but I know from previous experience I won't be able to stop the medication until after delivery which is rubbish. There are quite a few unpleasant side effects, constipated much?! X

MEXARAB · February 2015

Just saw commercial about this.

twindlej · February 2015

If u are concerned stop taking it. Remember many medications that are thought to be safe later prove to be not always so. Dr. are not always up to date on these things if they aren't of a continuing education mind. U need to be an advocate for yourself. In most cases it is probably safe and if u simply cannot go of because u cannot keep anything down, well malnourishment will certainly do more harm, but if u can I'd stop taking it. The stress isn't worth it.

lburgundyr · February 2015

My sister in law's son was born deaf, he is four years old and they still do not know what caused it. They have done genetic testing but that was no help at all. They are wanting to know about the medications she was on. She was given Zofran throughout her pregnancy. She talked to her ob and to a law firm. Both confirmed a recall. However it is specifically Zofran not the generic version.

Chellz0684 · March 2015

I had a friend today who called me to tell me she can't believe I'm taking it. That she would never take it and put her baby at risk with the claims it's starting. She is also pregnant. Of course I felt bad. But she does alot of things I wouldn't do either.

k3taeko · March 2015

ThisMakes5 said:
....Most people in general want an easy fix, they do not want to hear thst if they stop eating two bags of chips a day and get up off the couch they will start feeling better. They want the doctor to give them meds to help them lose weight while sitting on the couch eating the chips.

Americans are lazy.

Although I partially agree with your comment, I have to disagree that "Americans are lazy." I'm American and I workout and eat mostly healthy (so does my husband and our children will be active as well). I do however understand how that generalization is often made about Americans because boy, A LOT of them sure are lazy. I used to be a fitness coach but just could not deal with people moaning and groaning about their weight issues. These same people complaining also would do absolutely nothing to change it. It's ridiculous.

Anyway, on to the original post. I was on Zofran during my pregnancy for the nausea because I just personally could not tolerate it. I tried natural remedies but nothing helped. I could barely get out of bed to use the restroom without getting sick let alone even look at any food without having my stomach churn. I don't regret taking it and would continue if I still had an issue with all the nausea. It was the only way I could actually eat and properly nourish my baby.

Sanine · March 2015

I took zofran at the beginning of this pregnancy, but luckily don't need it anymore. But all I had to do to get it was mention I am nauseous and the Dr. prescribed with no further questions.

I think it depends on the doctor, but there are some here in America quick to prescribe medicine. When I lived in a different state I was able to get narcotic meds and antibiotics very easily. Where I live now its not easy at all and I have to prove I need either one. (This sounds like I was addicted but never was. I actually have a fear of being addicted to any medicine or alcohol).

AmommyB · March 2015

I've heard both sides and will give you my experience. I took it 12 years ago with my daughter and she was/is healthy as can be. I was also given Zofran with this pregnancy and so far it's been fine. I have also heard from people in the medical field that this current scare is more lawyer driven than medical driven. I am only sharing what I've personally been told and the experience I've had with it. I'm not a doctor lol. I think if you are really worried, there are other options. I was on phenergen this time around too and had success with it as well. I had such bad HG that I couldn't even hold down water, I had to take something. I wish you the best!

mamajbee · March 2015

I have major HG and my doctor didn't prescribe it till my 2nd trip to ER for moderate dehydration. I couldn't even keep water down. I did stop taking it out of concern and now am back to vomiting constantly and in my eyes, dying a slow death, lol. It just sucks because even on the generic version of it I was still miserable.

Make your own choice, talk to your doctors, I told mine I wanted to stop taking them just in case. My anatomy scan came back normal and no concerns but I'm dreading the next 17 weeks, I don't know if I can survive.

I wouldn't believe everything online nor those stupid lawsuit ads on tv for warnings. Speak to a pharmacist who gets that type of information a lot sooner than your doctor would. My aunts a pharmacist and she said it's fine and to take caution using any meds because if your just having mild pregnancy issues try the natural way first before medicating.

Good luck to all you moms suffering and those that aren't. ❤️ almost done with pregnancy and soon beautiful baby.

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