The Link Between Zofran and Congenital Heart Defects

    congenital heart defects

    The day a child is born can be one of the happiest of a parent’s life. Discovering that the new baby has a congenital heart defect (CHD), however, can quickly turn this joyful day into one of fear and worry. The term “congenital” essentially means a condition is present at birth, and, according to the Centers for Disease Control and Prevention, CHDs affect nearly 40,000 babies in the U.S. every year.

    A common type of heart defect often sees holes developing in the heart. These holes cause the blood to flow irregularly through the heart, causing serious health issues. For example, babies can be born with holes in the upper or lower part of the septum. The septum is a barrier that divides the two sides of the heart. The right side of the heart is used to filter oxygen-deficient blood to the lungs, and the left side receives the newly oxygenated blood and pumps it to the rest of the body, the National Heart, Lung, and Blood Institute said. When there is a hole in the wall separating these two sides of the heart, the blood can become mixed, sending low-oxygen blood back into the body and oxygen-rich blood back into the lungs.

    Defects usually have negative effects on a child’s health, with babies suffering from low blood pressure, breathing difficulties and poor weight gain, the American Heart Association noted. Heart defects have also been linked to slower development and learning difficulties.

    Defects Associated with Zofran

    Doctors often don’t know what causes congenital heart defects, although a link has been found between septal defects and smoking during pregnancy. In 2014, another causal link was discovered between heart defects and the use of Zofran during the first trimester of pregnancy. The study, published in Reproductive Toxicology, found a statistically significant increase in cardiac septum defects in women who took ondansetron (Zofran) while pregnant.

    Other defects associated with Zofran include:

    • Kidney defects
    • Cleft lip
    • Cleft palate
    • Club foot
    • Spina bifida

    Zofran was initially approved by the U.S. Food and Drug Administration in 1991 to treat nausea and vomiting in chemotherapy patients. Eventually, doctors began prescribing this medication off-label to pregnant women as a remedy for morning sickness. What these people didn’t know, however, is that this drug was not approved for use in pregnant women by the FDA. Many doctors were also unaware of this fact because the manufacturing company, GlaxoSmithKline, had misbranded the medication and was marketing it as a treatment for morning sickness without FDA approval.

    Recent Zofran Lawsuits

    As recently as July 21, 2015, a lawsuit was filed against the manufacturer GlaxoSmithKline (GSK) for negligence and fraud, among other accusations, the lawsuit stated. Parents of the child, referred to as B.B. in the case, claim the use of Zofran during pregnancy caused Tetralogy of Fallot, a congenital heart defect. This condition is rare and involves four heart defects, NHLBI says, including:

    • Ventricular septal defect: A hole in the septum.
    • Pulmonary stenosis: The pulmonary valve, which allows blood to leave the heart, cannot fully open, making the heart work harder to pump blood.
    • Right ventricular hypertrophy: The extra effort caused by the narrow valve, mentioned above, leads to the right ventricular muscle thickening.
    • Overriding aorta: The aorta is located over the ventricular septal defect, which allows oxygen-deficient blood to flow directly into the aorta and circulate throughout the body.

    This condition does not allow the blood to get enough oxygen, often causing a baby’s lips and skin to take on a bluish hue. This problem usually has to be fixed with open-heart surgery.

    Many other families have brought similar birth defect claims against Zofran manufacturers. Parents hope to gain some form of justice and compensation from the pain associated with the use of this drug.

    Contact an Attorney to Discuss Your Zofran Claim

    Birth defects can take a heavy emotional toll on parents who must constantly worry about their child’s health. Finances can also become strained as medication and surgeries to fix these conditions are costly. If you or a loved one took Zofran while pregnant and have a child with a birth defect, you may be entitled to compensation. Get in touch with a lawyer today and discuss the steps you should take to pursue a Zofran lawsuit.


    1. “Congenital Heart Defects (CHDs): Data & Statistics.” Centers for Disease Control and Prevention. July 9, 2014. Accessed July 29, 2015.
    2. “What Are Holes in the Heart?” National Heart, Blood, and Lung Institute. July 1, 2011. Accessed July 29, 2015.
    3. “The Impact of Congenital Heart Defects.” American Heart Association. March 18, 2015. Accessed July 29, 2015.
    4. Danielsson, Bengt, Birgitta Norstedt Wikner, and Bengt Källén. “Use of Ondansetron during Pregnancy and Congenital Malformations in the Infant.” Reproductive Toxicology. December 1, 2014. Accessed July 29, 2015.
    5. “Jury Trail Demanded.” United States District Court of the Southern District of Illinois. July 21, 2015. Accessed July 29, 2015.
    6. “What Is Tetralogy of Fallot?” National Heart, Blood, and Lung Institute. July 1, 2011. Accessed July 29, 2015.

    Jared Heath

    Jared Heath is the author of The Sound in the Silence. In his role as an SEO content and digital marketing strategist, Jared was directly responsible for managing DrugJustice.com's editorial calendar and published articles on this website from 2015 to 2016. He is now pursuing a new career as a chiropractor.

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