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Medicolegal, pregnancy

I took Zofran in pregnancy. My son has a heart defect. I’m not suing. Here’s why.

I suffered with extreme nausea during my pregnancy, I had triplets and I’m pretty sure I had a triple dose. I never threw up, but you know how your mouth salivates the moment right before before you vomit, that sensation that sends you running to the bathroom? I had that. All. Day. Long. For four weeks.

By day four or five I was beside myself. I was drooling on my knees into a trash can or a toilet almost constantly. I kept a kidney basin beside me as I charted in the office and my colleagues knew to leave a bathroom free. Just in case. If I could have been off work I would have, except I knew I would have to stop working around 20 weeks and I only had so much sick leave and vacation stockpiled. Besides, when you have a very long wait at your office and you know you’re going to be away for six months canceling clinics on short notice just isn’t an option. 

I tried saltine crackers, frequent small meals, low fat foods, ginger candy, ginger snaps, ginger tablets, ginger beer, vitamin B6, vitamin B6 mixed with doxylamine (I used Unisom OTC), Phenergan, and ondansetron (Zofran). All before 8 weeks. I tried everything for several days, if it didn’t work I moved on. 

The only thing that worked was the ginger beer. It was some local concoction and tasted disgusting, but sipping it slowly all day stopped the salivation and extreme nausea. I didn’t feel great, but it was the best of the bunch.

Fast forwards to my very premature delivery. Two of my sons survived and one, Oliver, had a very serious heart defect that required two surgeries and will need a third. I thought nothing of what I had taken during my pregnancy until I started seeing ads and articles pop up about Zofran lawsuits. Like these:

ZofrancardiacCould the Zofran I took for three or four days around 6 weeks be related to my son’s heart defects?

The problem with linking medications and birth defects is that unless there is an obvious clusters of defects (think thalidomide and limb reduction defects) or animal data suggesting a risk it’s pretty hard to study. Some drugs don’t cause birth defects in animals but do in humans and vice versa. Then throw in a background rate of birth defects of 2-3% and mix in a multitude of cofactors that are also related to heart defects like genetics, smoking, obesity, multiples, and opioid medications and all of a sudden what causes what becomes very unclear. A definitive study would need thousands and thousands of women. Drug companies are not eager to do prospective studies in pregnant women – if they guess wrong and there is a birth defect connection the legal implications would be huge. Pregnant women are understandably not eager to try new medications.

For this reason we often rely on birth registries to track down links between drugs and birth defects. These have inherent issues as many registries aren’t specifically designed to yield that information, but sometimes the data can be hotwired (or tortured, depending on your perspective) to see if there is a connection. The legal salivation over Zofran was likely triggered by one such study involving the Danish Birth Registry.     

Andersen et al published in Reproductive Toxicology a retrospective review of 1.5 million births and identified 1326 pregnancies that used Zofran in the 1st trimester. This study found no overall increase in birth defects with the exception of a specific type of heart defect called a septal defect, which occurred in 0.7% in non Zofran exposed pregnancies and 1.26% in Zofran exposed pregnancies. The authors concluded Zofran should be avoided in pregnancy based on these results.

Hmmm, I thought. Interesting. Especially as my son had a septal defect. Interesting, but flawed. First of all retrospective studies have inherent issues, so the study is FAR from definitive. While an almost two fold increase is concerning, it still means the absolute risk (1.26%) is very low. However, my real issue is with the actual numbers – 17 Zofran pregnancies had a defect. So while 1,326 pregnancies sounds like they looked at tons of people it all boiled down to 17 patients. Can one really draw any conclusions based on 17 affected pregnancies especially when two-thirds of the women took the drug after 8 weeks (meaning too late to have an impact). The study also did also not address dosing.

But it gets murkier. Another group looked at the same registry in a different way and published their data in the New England Journal of Medicine. They looked at fewer pregnancies (still more than 600,000) and identified 1,970 women exposed to Zofran. The investigators matched each woman who took Zofran with four who did not (this helps to control for other factors the registry may not have recorded) and there was no connection between Zofran and birth defects. However, half the women were 10 weeks or more and so Zofran possibly have been a factor for them. 

There are some older smaller studies looking at Zofran, but they are too small to draw any conclusions. Based on the Danish Registry Data, no matter which study you side with, I don’t think there is robust evidence that currently links Zofran with cardiac defects.

What if a future study study showed the increase in cardiac defect does go from 0.7% to 1.26% with Zofran? Well, it’s all perspective. For example, there are some medications for epilepsy that cause birth defects but sometimes the risk of changing anti-seizure medications in pregnancy are too great and so the risk benefit ratio falls with taking the medication and accepting the consequences. When it comes to morning sickness if you have some mild nausea there is not likely any risk with treatment that you would be willing to endure, however, if you have been vomiting non stop for a week you might have a different perspective on what constitutes potential risk. These conclusions take informed, collaborative decision making.

There is no study on birth defects with ginger beer so as far as I am concerned Oliver’s defect might well have been caused by the ginger beer. Or genetics (one grandparent had a cardiac defect that required surgery). Or that he was a multiple. Or bad luck. 

If GlaxoSmithKline hid information about Zofran then then that’s a different story, although drug companies typically can’t contaminate birth registries so given the registry data it’s hard to think there’s a treasure trove of bad safety data that would trump the registry findings. If there is data it should come out, but the cynic in me doesn’t think that’s the real purpose of these civil suits.

Is it possible more studies could show a risk? Yes, birth defect registries are specifically set up to answer that (and are the best thing short of randomized trials). Would that change anything? Not likely as Zofran isn’t the first line treatment, we only recommend it when things are really bad and everything else has failed. 

Medications should never be the first line for nausea and vomiting. There are other things to try first, but for some women, like me, these things will fail and then every woman has to decide her individual risk benefit ratio. Simply handing a pregnant women a prescription for Zofran with no counseling is bad medicine, going through the escalating interventions for nausea and vomiting and then ending up at Zofran when everything else fails and your patient is miserable and begging for help is a completely different thing. WIthout large randomized clinical trials and transparent data no one can say any medication is truly safe. Given there is a conflict from the same data set that should help people understand how hard it is to actually get clean data and good answers.

 And remember every time some personal injury lawyer decides a potential slight increased risk from a conflicting study means “let a jury decide” there is a direct negative effect on the willingness of companies to invest in studying morning sickness and fewer doctors will be willing to prescribe anything except Saltine crackers and sympathy.

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I have no industry conflicts to disclose

Discussion

23 thoughts on “I took Zofran in pregnancy. My son has a heart defect. I’m not suing. Here’s why.

  1. Not just epilepsy drugs; the acne drug Roaccutane is teratogenic. In the UK, girls/women who take it must have a pregnancy test first, and be on the oral contraceptive. If they want to have sex, they must also use condoms.

    Posted by korhomme | May 1, 2015, 1:19 am
    • I wish the er doc that saw me while I was pregnant would have given me zolfan. But I didn’t know there was any thing like that, so I was sooooo sick for 3 and a half months.

      Posted by Carol Jahnke | November 23, 2015, 5:29 am
  2. This was such a well-written article. I had been wondering about the recent blame of Zofran on birth defects. Thank you for putting this article together with facts and not speculative hype and fear tactics.

    Posted by elizabetcetera | May 1, 2015, 1:52 am
  3. really surprised you didn’t sue. well written article.

    Posted by clairvoymagt2 | May 1, 2015, 6:46 am
  4. I took zofran for months for three different pregnancies and still ended up in the ER for severe dehydration. Thank you for writing a well balanced and nuanced analysis. Cost benefit analysis indeed. Is zofran or severe morning sickness more dangerous? I eventually stopped taking zofran because it didn’t help me that much. They put me on even stronger drugs, that also didn’t help. All three of my children are completely fine (sure, my anecdote means squat in terms of statistics), but the misery of morning sickness and its affect on pregnancy can’t be underestimated. In fact, I was more depressed during those months of sickness than with the baby blues or borderline ppd. Those months were very dark and trying to explain constant, unending, dehydrating, exhausting, scary sickness like that is difficult to those who haven’t experienced it. Having such severe morning sickness is not just a physical, but also a psychological issue (and economic for many women), all factors that need to be taken into consideration when assessing risk based on, as you say, a necessarily flawed methodology.

    Posted by Meredith (@meremotherfig) | May 1, 2015, 8:07 am
  5. I loved reading this, and am really enjoying your blog. I’m also an attorney, so I’m personally impressed (and pleased – I’m not a plaintiff’s attorney😉 that you didn’t sue. So many people would, and do…I have two boys, ages 2 and 4, and with both pregnancies I had to take zofran (8mg dose during first pregnancy, 8 and then backed off to 4mg dose during second pregnancy) every single night in order to sleep (I cannot sleep through nausea AT ALL). Without it, as soon as my blood sugar dropped even modestly, I would become sick (either the way you describe – almost desperate TO puke) or actually vomiting). The first time, I was so afraid to take anything, and my RE was appropriately cautious in offering it, but in the end I was too miserable and couldn’t work or sleep. I was on zofran, with my first, from 6-8 weeks till the day I gave birth, and with the second (when I felt much more comfortable with the drug, from six weeks until I gave birth.) My boys are absolutely fine (thank God) and I give thanks EVERY day (as well as every time we get a stomach bug in the house!🙂 for that drug. For me it was truly a lifesaver. Thank YOU for your perspective and this awesome blog. I look forward to reading more!

    Posted by Angela | May 1, 2015, 9:47 am
  6. Dr Jen, I know you were impressed with the NHS after your experience a few months ago. Sadly, ‘financial pressures’ can make zofran unavailable for some. This is a ghastly story:

    http://www.theguardian.com/commentisfree/2015/apr/24/abortion-extreme-morning-sickness-hyperemesis-gravidarum

    Posted by korhomme | May 1, 2015, 10:06 am
  7. Truth is, all RCTs and case-control studies are horribly underpowered when it comes to investigating the true risk of ‘rare’ side effects. 5 or 10% confidence is basically no confidence at all.

    You can choose not to sue. That is your choice. But that has nothing to do with the true risk of this drug.

    Posted by Andrew | May 3, 2015, 7:23 am
    • In the US true risk has nothing to do with lawsuits. Regardless, the current data does not show risk – 6 exposed patients (2/3 of 17) from a retrospective review of a birth registry does not equate with anything except statistical manipulation.

      Posted by Dr. Jen Gunter | May 3, 2015, 12:07 pm
  8. I’m no that into kids, but that one is pretty darn cute!

    Posted by Colleen | May 4, 2015, 11:00 am
  9. Never have been pregnant and never will – wrong chromosomes! – but I do love Zofran. Got me through chemo for CLL without vomiting once.

    Posted by lancelotgobbo | May 11, 2015, 5:54 pm
  10. I think this is a very good article and like everyone said, it was well written. I took Zofran when I was pregnant with my second son. The thought of food made me gag and throw up. I thought everything was fine until he turned 2. I noticed he had a hard time talking and socially things were off. He is now 3 and has been diagnosed with Expressive Language Disorder and Sensory Processing Disorder. My other 2 children…his older brother and younger brother were both healthy. Unfortunately, as you stated there is not sure way to link these side effects to the drug, but I think the fact that Zofran was even prescribed to us without letting us know that it was not meant for pregnant women was ridiculous! I think we should have been told that the FDA did not clear the medicine for pregnant women instead of everyone raving that it worked so well. I feel betrayed that I trusted the doctor and now I’m teaching my son how to talk and how to stay calm when he hears loud noises. Another girl I work with took Zofran and her son is autistic. I think the basis of any lawsuit should be the fact that it was prescribed to pregnant women and the FDA never cleared it to be used in that way.

    Posted by Jacqueline Childs | July 11, 2015, 12:52 pm
    • ALmost every single medication a pregnant woman takes during pregnancy has not been approved for use in pregnant women by the FDA. Many of them have not even been tested in pregnant women. COmpanies don’t want to risk a bad outcome, as I explained above. Tylenol for starters. Codeine. Morphine. In fact every single drug for pain.

      The issue with Zofran is not that it is unsafe, the data do not tell us that. Regardless, it should only ever be prescribed appropriately, that is after more tested options have failed and when a pregnant woman is in real distress with her nausea/vomiting.

      Posted by Dr. Jen Gunter | July 11, 2015, 11:43 pm
      • I know this is a late comment, but I think it’s interesting that you posted this before the latest tylenol studies came out indicating an increase in ADHD/sensory processing issues in women who took tylenol often during their pregnancies (I think the cutoff was more than 27 times). Not that the study was any more well-designed than the Zofran study, but the orginal poster could point to any number of things happening during her pregnancy to account for her child’s problems, including just being a normal part of statistics which happen even in completely chemically pure pregnancies (not that there is any such thing in today’s modern world).

        Posted by Christina | July 3, 2016, 4:55 am
  11. Dr. Gunter,

    My name is Michael Monheit. I’m the personal injury attorney in the screenshot you used. I lead my own law firm, Monheit Law, and along with a number of other lawyers have established two websites that focus on Zofran, its potential link to birth defects and the litigation against GlaxoSmithKline.

    I don’t have any problem with you using my likeness. But I have written a response to your arguments. It’s published here: http://zofranlegal.com/why-we-file-zofran-lawsuits/ and I’d welcome a response. Feel free to post a comment on my blog if you’d like to leave one.

    – Michael Monheit, Esq.
    Monheit Law, P.C.

    Posted by Michael Monheit | September 14, 2015, 8:42 am
  12. I was searched for info on this topic and was thrilled to see you’d covered it! I have nine-year-old twins born at 23 weeks, so your story is close to my heart (and I’d love to have coffee with you someday to discuss the long-term impacts of treatments for prematurity). Could you please clarify this sentence? “However, half the women were 10 weeks or more and so Zofran possibly have been a factor for them.” I think you meant it wouldn’t be a factor.

    Posted by Courtney | September 24, 2015, 8:53 am
  13. I agree, Medications should never be the first line for nausea and vomiting. Besides heart deficiencies Zofran has been linked to musculoskeletal abnormalities, club foot, cleft lip and/or palate and jaundice.

    Posted by Tammy Corbett | September 30, 2015, 6:05 am
  14. I had severe NVP, 24/7 with all three of my children. I couldn’t eat or even drink water without throwing up. At that time Zofran was not approved in Canada but I got a dose after I passed out in the bathroom on a work trip in the US at 6 weeks along. When I came back home I was left to suffer and lost 25 lbs. as there was an acute lack of information on hyperemesis. My other children are here because of Zofran which was later approved (not for pregnancy, but used off label)- a statement I don’t make lightly as I normally shy away from medication. This is a miracle drug for people like me, so it’s a difficult call. If you have not experienced the incredible suffering of vomiting 100 times a day for 8 months, bursting blood vessels your face, being unable to bathe or move from weakness and begging for someone, anyone to end your suffering – you cannot judge a woman willing to take this drug to continue her pregnancy. I blame the medical/research establishment who put women into these positions by not allocating proper resources for women’s health issues in the first place. If men had to vomit for 8 months straight, believe me there would be extensive studies and serious treatment protocols, not obnoxious doctors telling them to eat crackers and “tough it out” while they threw-up blood and wasted away.

    Posted by Stephanie | December 10, 2015, 6:59 pm
  15. Now that I have come across your medical background I wonder if you prescribed this drug to your patients and has that effected your decision to not seek legal action?

    Posted by jacksheart | February 25, 2016, 10:20 am
  16. Unfortunately my heartfelt response to your thoughts didn’t come through which was very disappointing.

    Posted by jacksheart | February 27, 2016, 6:36 pm
  17. I wanted to share my story as I took Zofran with my first pregnancy from 6 weeks until the day I delivered. I started actually vomiting before the your pregnant line even showed on the home test, and continued every day after for all 9 months. I threw up 8-12 times a day and couldn’t even keep water down. By the time I was 8 weeks pregnant I had already been hospitalized 3 times for severe dehydration and then I began to seizure. The ER was the first to prescribe Zofran, but they would only give me about 5 pills and once ghost ran out I was back in the ER a few days later. My OB then gave me a full script which I started taking daily and took until my delivery. My beautiful girl was born completely healthy and I am so grateful, but honestly if it wasn’t for the Zofran I might have lost her. For each person I believe you have to weigh your own risks.

    Posted by monni1489 | May 6, 2016, 10:55 am
  18. Thank you for writing this. My nausea and vomiting has been horrible and I was prescribed zofran. I do wish my doctor would have gone through the risks with me (especially when I bluntly asked) but zofran has really helped me through this pregnancy. What hasn’t helped are the numerous moms that make snotty comments about zofran and make me feel like I’m already a bad mom. Sorry that your son has a heart defect but it’s nice to see that you have a reasonable head on your shoulders.

    Posted by Joelle | August 19, 2016, 12:59 pm

Trackbacks/Pingbacks

  1. Pingback: Only Kim Kardashian can afford Diclegis, the Birkin Bag of morning sickness medication | Dr. Jen Gunter - August 19, 2015

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