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Zofran Birth Defects


Concerns have been raised about the possibility that Zofran side effects could include a risk of birth defects when mothers were prescribed Zofran to treat morning sickness. Although studies have produced conflicting results about the risk of Zofran birth defects, one news investigation has reportedly turned up reports of heart defects and kidney malformations in newborns who were exposed to Zofran prior to birth. The US Food and Drug Administration (FDA) has issued warnings about the risk of serious Zofran adverse events.

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Zofran Side Effects

Zofran (known generically as ondansetron or ondansetron hydrocholoride) is approved by the FDA to prevent nausea and vomiting linked to cancer chemotherapy, radiation therapy and surgery. It is often prescribed off-label to treat morning sickness in pregnant women. Zofran is in a class of medications called 5-HT3 receptor antagonists and is given either orally or through an injection.

In 2011, the FDA issued a warning that use of Zofran could result in an abnormal heart rhythm, including QT interval prolongation and Torsade de Pointes. The FDA advised patients with congenital long QT syndrome should not be treated with Zofran. Additionally, the agency required GlaxoSmithKline to conduct a thorough QT study to determine the degree of risk.

Zofran Birth Defects

ssrisapgarStudies concerning Zofran and birth defects have returned conflicting results. One study, published in The New England Journal of Medicine (2/28/13) found no link between the use of Zofran while pregnant and an increased risk of spontaneous abortion, still birth or major birth defects. A different study based on the same database used for The New England Journal of Medicine Study, but covering a longer period reportedly suggested a two-fold risk of cardiac birth defects.

That second study was presented at the International Society of Pharmacoepidemiology in Montreal in 2013. Researchers found that women who took a different drug, metoclopramide, had no increased risk of having a baby with birth defects.

In 2014 a Canadian newspaper, The Toronto Star (6/25/14) undertook an investigation of Zofran. The investigation found that at least 20 Canadian women who used ondansetron while pregnant experienced fetal side effects, including infant death, low birth weight, and heart and kidney defects. The heart defects included heart murmur and atrial septal defect.

Zofran and Serotonin Syndrome

Concerns have also been raised about the risk of serotonin syndrome in pregnant women who take a selective serotonin reuptake inhibitor (SSRI) and Zofran or another 5-HT3 receptor antagonist at the same time. The concern is that both types of medication modify the amount of serotonin in the patient's brain, which could lead to serotonin syndrome, a potentially fatal condition. Symptoms of serotonin syndrome include confusion, agitation, lethargy, coma, hyperthermia, nausea, vomiting and tremors.

According to a report from the FDA, as of February 13, 2013, the agency had received 39 reports of serotonin syndrome linked to ondansetron.

Zofran Lawsuits

In 2012, the US Department of Justice announced that GlaxoSmithKline, maker of Zofran, would pay more than $1 billion to settle claims that it illegally marketed Zofran and other medications for off-label, unapproved uses. Specifically, GlaxoSmithKline allegedly "promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women." Although doctors are free to prescribe Zofran for off-label use, it is illegal for a drug company to market its medications for unapproved uses.

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ZOFRAN BIRTH DEFECT LEGAL ARTICLES AND INTERVIEWS

Zofran Litigation Making Progress
Zofran Litigation Making Progress Houston, TX: Another Zofran lawsuit filed by parents in Texas joins more than 300 suits filed nationwide against the manufacturer. Most all federal cases consolidated into a multidistrict litigation in Massachusetts are making progress and a first trial date is expected soon [READ MORE]

Zofran Complaints Mounting with Increased Awareness of Birth Defects
Zofran Complaints Mounting with Increased Awareness of Birth Defects Birmingham, AL: Many women who took Zofran during their pregnancy had idea that it is prescribed “off-label”, meaning it wasn’t approved by the FDA to treat morning sickness [READ MORE]

Mothers Regret Taking Zofran
Mothers Regret Taking Zofran Hattiesburg, MS: “Getting money from the Zofran class-action lawsuit isn’t as important to me as getting the word out to the public about how dangerous this drug is,” says Lucy. Her daughter was born with clubfoot, a birth defect associated with Zofran [READ MORE]



READER COMMENTS

Posted by
Lisa W.
on
I was prescribed and took Zofran in November-December 2004. I had severe morning sickness and was also given Zofran by IV. My daughter is 11 but has had 9 years of speech therapy and is approximately 2 grade levels behind in school despite extra circular tutoring, an IEP and constant exposure to reading and math. I am not sure if this is a known defect but she had severe jaundice at birth and her speech was delayed significantly. I'd like to join the lawsuit because of these continuing issues. I really wish I had never listened to my doctors and had just dealt with the nausea.

Posted by
Sherry griego
on
I took zolfram for morning sickness with 2 of my children both have enlarged hearts plus not only having an enlarged heart he has ticks unknown to childrens hospital where they came from I wonder if its from this medicine

Posted by
Regina Cane
on
I used zofran after the first couple of months of pregnancy with my first son. He has severe jaundice at birth but was otherwise healthy. I searched the internet about zofran/ondansatron and found nothing negative in 2011 when I was prescribed the medication and told that it was "safe and effective"' I became pregnant in 2014 and started taking zofran from the time I found out thinking that my first child was fine and still at that time there was nothing on the internet negative about taking the drug during pregnancy so I had it prescribed right away. My second son was born with hypospadis (pee hole not in the right place) and underdeveloped foreskin. He will require surgery on his penis to correct this issue at some point in the future. He also had jaundice. He also seems to have issue with constipation even though we are vegetarians. So sad that I believed my doctor that this medication was safe. I would have dealt with the nausea had I thought it would cause my son to be born with a birth defect.

Posted by
jordan candelera
on
it was common when we were in the hospital with our twins to see women having stillbirths all around us(all high risk) when taking of all drugs Zofran. Nurses were like we dont know why but they were pushing it on us and we refused to take it. Didnt know how bad it was until i read more in 2014 on this drug. The nurse ekpt saying well we trust it, you should too. I disagreed then and am glad now

Posted by
Shelly Colegrove
on
I was taking Zofran for morning sickness, however, I did not take the medication for the first trimester. My Doctor told me he could not give me medication for nausea until the second, it was never explained why, I thought he was a high risk doctor and knew what he was doing. He must have know something was not right or he would have given it to me sooner, however, I was uneducated and thought it was a safe thing to do. Doctors and staff assured me if I help the babies seventeen weeks not to worry. I lost them, both girls, on Memorial Day 2015 in less then a 20 minute drive. I went into labor driving, I suffer from PTSD, I was told I was not having a baby and was forced into a bathroom alone to change when I had to catch my first daughter. I always blamed myself,

Posted by
sharleen decarlo
on
After being told zofran was safe for my baby I took it for two days before miscarring my first child

Posted by
katharine madjid
on
I had a stillbirth baby while taking Zofran

Posted by
California
on
Both my girls have had health issues their whole life. Both have had surgeries. I took Zofran for hyperemesis and basically lived on it for three months with both girls. I want to be a part of this lawsuit please.

Posted by
California
on
I suffered a stillborn pregnancy after taking Zofran and my baby never made it to full-term.

Posted by
Texas
on
I suffered a stillbirth in August 2004 after taking Zofran for severe morning sickness. My stillborn daughter's cause of death on her certificate was listed as cardiac arrest (“unknown causes”). Her autopsy found nothing and my doctor claimed it was a “freak accident.”

Posted by
Louisiana
on
I suffered a stillbirth while taking Zofran.

Posted by
Oklahoma
on
My daughter was born with two holes in her heart on the left side and the malformation of artery on the right side. She was born in May in 2008 and underwent surgery in Sept. 2012 . Not only was she caused physical damage but she and I both underwent significant emotional damage. I was prescribed the drug due to severe nausea. I even received the drug through IV at one point when I was hospitalized from conditions of being unable to hold down food. I was also prescribed the drug with my previous pregnancies and each child was born with a less severe heart defect, but very premature at only 31 weeks gestation.

Posted by
Oregon
on
My son had gastroschisis and omphalocele birth defect. He passed away after birth in 1998 from heart failure. I had a heart condition (murmur, racing heart, fainting, panic attacks) with my third pregnancy. My daughter was born with foot abnormalities and a small hernia in 2005. I had a miscarriage in 2013; the baby's heart just stopped. I have used Zofran in all pregnancies.

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