Zofran Lawsuits

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Pregnancy side effects of Zofran, an anti-nausea medication commonly used for morning sickness, may increase the risk of children suffering severe and debilitating birth defects. 

STATUS OF ZOFRAN LAWSUITS: As a result of GlaxoSmithKline’s failure to adequately research their medication or warn about the risk of congenital malformations, potential Zofran birth defect lawsuits are being pursued by families of children throughout the United States who have developed:

  • Cleft Lip
  • Cleft Palate
  • Heart Defects



OVERVIEW: Zofran (ondansetron) is a prescription medication introduced in 1991 for treatment of nausea and vomiting associated with chemotherapy or following surgery. However, it has been widely prescribed off-label for morning sickness in pregnant women, despite a lack of evidence to establish that it is safe for the unborn child.

The medication can be administered as a pill, oral solution or as an injection. Zofran is a member of a class of drugs known as 5-HT3 receptor antagonists, and works by blocking the actions of serotonin.

Several studies have raised concerns about the risk of Zofran side effects causing unborn children to suffer various birth defects or malformations, including cleft palate, cleft lip and congenital heart problems, such as atrial septal defects or ventricular septal defects.

Use of Zofran has also been linked to a risk of serious and potentially life-threatening heart rhythm problems for users.

ZOFRAN BIRTH DEFECT RISKS: Although Zofran has never been approved for use by pregnant women, it is widely promoted as a morning sickness drug.

For years, the only basis for the safety of Zofran in pregnancy was a small 2004 study published in the BLOG: An International Journal of Obstetrics and Gynaecology, which involved only 176 women using the drug.

While the research found no statistically significant differences in the rates of major malformations between women prescribed Zofran and other groups, the limits of the study were only able to rule out a 5 times risk.

As early as 2006, a study from Hong Kong found evidence that Zofran crosses the placenta when taken by pregnant women. At the time, researchers called for more studies to be conducted on the fetal effects of Zofran on unborn children.

In 2011, as part of the National birth Defects Prevention Study, researchers from Boston found an association between the use of Zofran and an increased risk of birth defects. The finding came as researchers were looking to see if nausea and vomiting in pregnancy itself, commonly referred to as “morning sickness” was linked to birth defect risks. Instead, they found that women who took Zofran had more than double the risk of giving birth to a child with cleft palate malformations.

The next year, Dr. Gideon Koren, director of the Motherrisk Program in Canada, noticed an increase in the prescription of Zofran to pregnant mothers to combat morning sickness, and warned against the drug’s use during pregnancy citing both a risk of birth defects that could affect the child, and heart problems that could affect the mother.

In February 2013, a historical cohort study involving more than 600,000 pregnancies in Denmark was reported to find that there was no link between Zofran and birth defects. However, experts have pointed out that the average gestational age of exposure to Zofran was 10 weeks, so more than half of the women involved took Zofran after the baby was no longer at risk of congenital malformations during the first trimester.

This same data was examined by another group of researchers in August 2013, which involved 900,000 pregnancies over a longer period of time. That study found that Zofran doubled the risk of heart defects (PDF) and may be associated with a 30% increased risk of birth defects overall.

In 2013, Dr. Koren again warned in Pediatric News about the unknown pregnancy risks with Zofran. He indicated that most clinicians appeared to be ignoring or unaware of the risks and called for more monitoring of pregnant women on Zofran, noting that electrolyte imbalances could leave them more vulnerable to Zofran heart problems.

More recently, in 2015, Swedish researchers published a study in Reproductive Toxicity which found that women who took Zofran during pregnancy were 62% more likely to give birth to children with cardiovascular defects.

In October 2015, the U.S. Judicial Panel on Multidistrict Litigation decided to centralize all Zofran lawsuits pending throughout the federal court system before one U.S. District Judge in Massachusetts for coordinated discovery and pretrial proceedings.

ZOFRAN HEART SIDE EFFECTS:  Although warnings have indicated a potential risk of heart rhythm problems on Zofran, known as QT prolongation, the FDA required additional information be placed on the drug in September 2011.

Zofran has been linked to a risk of changes in the electrical activity of the heart, which can cause prolongation of the QT interval of a electrocardiogram (ECG). This may result in an abnormal and potentially fatal heart rhythm, such as Torsade de Pointes.

Updated Zofran warnings indicate that the medication should not be used in patients with congenital long QT syndrome because they may be at a particular risk of Torsade de Pointes from Zofran.

At that time, the labels were also updated to recommend ECG monitoring in patients with electrolyte abnormalities (e.g. hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or in patients taking other medications that can lead to QT prolongation.

GlaxoSmithKline was also ordered to conduct additional studies to assess the risk of QT prolongation from Zofran.

A Zofran recall for a 32 mg single, intravenous dose was ultimately issued due to the heart side effects. Adults and children suffering from nausea and vomiting caused by chemotherapy can continue to receive the lower dose of 0.15 mg/kg, administered every four hours for three doses. The update does not change any recommendations for oral dosing regiments.



  1. E Carter Reply

    Should pregnant women take Zofran for nausea and vomiting?

  2. Judith Reply

    My father was on Zolfran for several years and passed away on 8-23-2000 in the hospital from heart complications. He died in Huntington, West Virginia. I was going to drive up from Florida to help with his care when he was admitted to the hospital .

  3. daniel Reply

    My wife took zofran while pregnant and during child labor iv and my son was born with cdh congenital dyafrmatic hernia. In such we almost lost him like 1/10000 babyie make it passed the first six hrs but duke saved him but there are many other dissabilitys associated with him I feel like if the doc did the last ultrasound on him he would have seen the defect and had time to fix it with a microsurgery. In the womb also among other probs the doc Was LATE FPR A MOVIE SO HE RUSHED LABOR IT TOOK LIKE FIVE MIN TO HACE HIM

  4. Kelly Reply

    It’s been 21years since my twins were born but if i remember correctly i was on zolfran for a few months and one of my twins has alot of the medical issues that are noted in the article

  5. Tommi Reply

    I was prescribed zofran after my first trimester for severe nausea and vomitting. I was told it was completely safe and I could take up to 3 a day. My son was born with two holes in his heart, PDS, and ASD. We are awaiting heart surgery in April.

  6. Rich Reply

    my daughter was born with two holes in the the heart by the generic drug ondansetron.this drug has the same make up as zofran. people need to sue these other makers as well.

  7. randi Reply

    I took zofran while pregnant and my child was a stillborn

  8. Lady Reply

    I went into the emergency room yesterday (7 weeks pregnant) for severe nausea.. The doctor gave me a zofran pill as well as a prescription for more.. Last night I saw a commercial about the birth defects.. My question is if it’s known that zofran causes birth defects why was I prescribed this harmful drug??? If I hadn’t seen the commercial I would have taken more…

  9. bridgette Reply

    I went to the ER yesturday and they gave me Zofran and a prescription for more. i seen the zofran recall commercial and was like wth did they give me this drug if its harmful icd i be damn if i take anymore of them.

  10. diamond Reply

    I am 2 mos pg and I been taken zofran tell just now the er gave them to me what if a am to late and my baby don’t make it or something gose wrong I don’t think I could take losesing another baby I am only 25 and I just lost one not long ago why did the DC give this two knowing how up set I was when I found out I was having a baby cuz my past son didn’t make it pass 5 mos in me I asked the DC if my baby was ok and was going to be healthy and everything I was even crying and so the DC turns around and gives me zofran so I can keep at less something down for my baby but today I see on TV that it could not just hurt my baby but kill it really that’s fucked up this needs to stop cuz no matter what you may get out of a law suit. It will not help the pain that zofran and the DC may have caused

  11. ARP Reply

    Wow, first please let me express my sympathy for all the pain you and your precious little ones have been through. It’s awful when any babies suffer, no matter what the cause. Also,before I go any further, please know that I’m writing this comment with the upmost respect for the parents here who are facing many challenges in caring for their children.
    We have 3 children so far. My oldest, an 8yo son, is the only one with any health issues as of now. He was in the NICU and later developed dental, digestive and colon issues that required surgery, several specialist, physical therapy, and medication, respectively; but I do know, however, that none of this was caused by Zofran. I had awful morning sickness that lasted all 3 trimesters, that was over 8yrs ago, but I had never even heard of Zofran. With my last 2 pregnancies I had severe HG, but I had another child(ren) to raise this time and couldnt be “out of commission” for 9mo again. As a result, I took zofran every day, from my first appt @6wks all the way through to the day I delivered. On a good day, I’d take half. On really bad days I’ve, taken up to three. Both babies had no congenital defects at all. They’re, still very young, so there’s no way to know if/when latent effects could occur.
    Just to be clear, I’m not trying to debunk this based on my kids being alright. I just find it odd that I took much more than most women used, but experienced no congenital defects.
    So, I simply wanted to ask some questions (if you don’t mind answering of course), so I can gain some further knowledge in the event that we have more children.

    1. At what pregnancy week did you start taking it?
    2. What week did you stop?
    3. Brand name or generic?
    4. What Mg dose?
    5. ODT or Pill?
    6. How often did you take it(daily,weekly, etc.)?
    7. What are you hoping to get out of these lawsuits? Better risk discussion? Proper warning on label? Complete recall/ban? Monetary settlement? Pick as many as you need or add your own.
    I really am genuinely curious.
    Thank you so much in advance.

  12. Margo/ California Reply

    I have a 3 year old that while I was pregnant noticed something abnormal with his heart on the ultrasounds. He was born with a heart murmur. Luckily it doesn’t seem to affect him but I can’t help but wonder if its from the zofran I took while pregnant. Can anyone give any advice?

  13. Kia Reply

    I took Zofran the generic brand back in 2010 while was pregnant with my now5yr old son. At the tender age of 6mths he went in the hospital with RSV then again after his 1st birthday. It didn’t alarm me until he went back in before his 2nd birthday. After that I begin to research this drug and was not very happy abt the results. Here it is 3yrs later and my son has been diagnosed with ADHD, ODD and Anxiety. There is no doubt in my mind that this drug played a big part in his mental illness. If you all can help me in anyway please give me a call and to all the expectant mothers stay far away from this drug. I took it 7mths of my pregnancy and now I have to deal with my son mental illness the rest of our life and it’s not worth it.

  14. April Reply

    My son was born october 2008 and was diagnosed with a congenital diphramatic hernia.. several test was done and everything came back normal as far as it being genetics I took zofran the first 4 months of pregnancy.. my son lived for 18 days and passed away due to his birth defect. whoever created this drug needs to suffer every consequence that comes with it and be banned from the pharmaceutical industry nobody deserves to endure the pain I went through. I will keep everyone In my prayers who have or is going through this.

  15. Harmony Reply

    I had my daughter in 5/2013. She was born with cdh and chd.This was after taking zofran throughout most of my pregnancy. Sadly, she died 5 hours after birth. I spoke to some lawyers about whether I had a case and they said because of Texas laws, I was trying to sue too late. It had to be within two years. I just can’t believe an evil company like Glaxo could get away with this. Heartbreaking and infuriating.

  16. Sarah Reply

    I took zofran due to bad nausea during my pregnancy, I believe it was right between the first and second trimester. Or it could have been right at the beginning of the 2nd trimester, I really don’t remember. Although I do know I took it in November 2011 because Thanksgiving was right around the corner and I was worried I would be too nauseaus to go over to eat Thanksgiving dinner at my parents house. I gave birth to my son in March 2012 and he was born with a cleft palate. This cannot be seen on an ultrasound so we were completely surprised. Needless to say the ensuing months were horrible. Babies who have cleft palate are not able to breastfeed because they are not able to make a sucking motion due to the malformation in the upper palate. We tried every bottle that is made but could barely get any formula down my son. He was so skinny that he literally looked like one of those children they show you in the commercials asking you to adopt a starving child from Africa (or wherever). Needless to say he cried nonstop day and night because the poor thing was starving!! We were at our wit’s end. My husband and I both went for months without any sleep at all. Our marriage was severely affected and we are now in the process of getting divorced. Finally, in July 2012, my sons pediatrician said he had to be hospitalized with a g tube because there was no other way to get food in him. He was not even in the 1st percentile for weight. He was literally going to starve to death. There is a lot more to my story but I’ll leave it at this: if I had known that Zofran was most likely the cause for my son to be born with a cleft palate, I never, NEVER would have taken that pill. These people need to be held accountable for the devastating pain and suffering they have caused to so many families and children.

  17. Christina Reply

    My son was born June 29 2012 I took zofran while pregnate with him the first trimester, he has had multiple health problems he has s shaped scoliosis one point an enlarged liver ,a hernia operation ,constant stomach issues that makes him vomit .he has had oral surgery because most of his baby teeth rotted as soon as they came in he has had surgery to remove his tonsils and has tubes put in both ears and now still might have to have eye surgery ,

  18. Jenny Reply

    I was prescribed zofran since my first tri for my third child. I took it daily several times a day, till my labor. I was sick my whole pregnancy. I had the worse nausea and vomiting beginning to end. What I noticed is that my son had developmental delays. It took him over two years to speak a full sentence. He would cry to try to communicate. Now at 6 it still takes him a while to get a sentence out, he will restart if he doesn’t say it right. He has digestive issues which makes him lactose intolerant. Also has asthma which he needs nebulizer tx, sleep apnea, and fever seizures. He gets aggravated too fast. When he was born he had the worse colic till 6 months. My child gets sick very easily as well. Totally different from my other two. Difference is I took zofran during my last pregnancy. My other children are healthy as oxs. No issues. I’m Convinced all of his issues was caused by this drug.

  19. Candaice Reply

    My daughter became extremely ill in early 2019 and could not eat anything but soft foods due to the feeling of food becoming stuck in her throat and vomiting it back up. For 10 years she had been treated for reflux. I was finally able to talk the pediatrician into doing an upper GI in March of 2019 to see just how bad things were. The test saved her life. My daughter was born with a heart defect that nobody had found until that day. Her aorta is on the wrong side of her heart and cause her to develop a vascular ring in which her blood vessels wrapped around her trachea and esophagus. The vascular ring had just about closed these off completely. In July 2019 she had surgery to correct the vascular ring. Now here we are a year and a half later facing a second surgery to do more repair. I took Zofran all 9 months of my pregnancy with her for extreme nausea and vomiting. I was not on any other medications besides prenatal vitamins. No child should have to suffer because pharmaceutical companies want to stay rich.

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