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Zofran pregnancy use could result in cleft lip and palate or heart defects
Zofran pregnancy use could result in cleft lip and palate or heart defects

Zofran® was approved by the U.S. Food and Drug Administration (FDA) in 1991 to treat nausea and vomiting caused by chemotherapy and radiation. The drug was also prescribed to treat morning sickness in pregnant women, but it was not approved by the FDA for this use.

The Center for Birth Defects Research and Prevention published a study in 2012 suggesting that women who used Zofran® during the first trimester of pregnancy had a twofold increase risk of having a child with birth defects.

Possible Zofran birth defects may include cleft lip, cleft palate, and congenital heart defects. Although Zofran® was not approved by the FDA for morning sickness, GlaxoSmithKline (GSK) promoted off-label use of the drug. GSK agreed to pay $3 billion in 2012 to settle numerous allegations including illegally marketing Zofran® for non-approved use.  Mothers who took Zofran® during pregnancy and had a child with cleft lip, cleft palate, or heart defects may be entitled to compensation.  Contact a Zofran lawyer to find out if you and your child are eligible for compensation.


  1. Gravatar for joel santiago
    joel santiago

    my fiancee has been taking zofran through out her pregnancy-she's 5 months pregnant- because she's been suffering from severe morning sickness , should she stop taking zofran now? she takes the med 3 times a day.

  2. Gravatar for angel

    My daughter was taking zofran up to 4 months pregnant and is now 7 months pregnant. She took a few last week because naseua came back. Is there a way to know if it affected the baby?

  3. Gravatar for Marlyn

    My son was born with clubfeet and I took Zofran during the first few months of my pregnancy. Did Zofran cause my child to be born with this birth defect?

  4. Gravatar for Christine

    I took zofran during pregnancy my son died at 7 weeks old of heart issues

  5. Gravatar for Brandi Marble
    Brandi Marble

    I took Zofran once, and then heard about that little use something that could affect my baby?!?!

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