Zofran Birth Defects – New Hampshire Zofran Attorneys

Overview of the Zofran Cases

If you were prescribed Zofran during pregnancy and gave birth to a child with a birth defect, you may have a claim against the manufacturer of the drug. Zofran is an anti-nausea drug manufactured by GlaxoSmithKline (GSK), who failed to properly warn consumers and physicians administering the drug about complications of the medication.

zofran-lawsuit-new-hampshire-2The original intent for Zofran (generic: Ondansetron) was to treat patients undergoing surgery, chemotherapy, or radiation. The drug was approved in 1991 for those uses. However, it has since been often prescribed off-label to help women overcome morning sickness during pregnancy. The drug helps with nausea, but has been known to cause serious birth defects, especially when taken during the first trimester (the most important stage of an infant’s development).

If you were in the unfortunate situation of having a child born with birth defects after taking Zofran during pregnancy, we can help advise you of your rights. Class action lawsuits can often leave people feeling helpless, and just another “number” in a lawsuit. The lawyers at Gottesman & Hollis will consult with you and advise on whether you should be part of a class action, or if it is in your best interest to file an individual claim.

Zofran Used as an Anti-Nausea Drug

Zofran, or known generically as Ondansetron, is a tablet, liquid, or injection used to treat women suffering from moderate to severe morning sickness. The medications are classified as 5-HT3 antagonists, which affect the central nervous system. It was first marketed by GSK in 1991, and generic brands started producing the drug in 2006. The production by generic brands made the drug even more popular for the treatment of morning sickness in pregnant women.

As with all medications, there are warnings of common side effects. The common side effects of Zofran can be an allergic reaction in the form of rashes or hives, fever or chills, difficulty breathing, and swelling in the face, lips, tongue, or throat. Additionally, diarrhea, constipation, headaches, and a tired feeling or drowsiness may occur.

Zofran Can Cause Serious Birth Defects

The above side effects are simply temporary issues, that are often resolved by stopping use of the drug. However, the reason a lawsuit may be in order relates to the far more serious issues Zofran has been known to cause. The drug has caused birth defects in many women, and you may have a valid lawsuit if your child was born with any of the following defects:

  • Cleft Lip or Cleft Palate

    Zofran has been linked to causing cleft lips or cleft palates in newborns as a result of the mother taking the drug. Children can experience feeding problems and health problems, severely impacting their overall well-being. Reconstructive surgery (sometimes involving multiple procedures) is often performed for children born with a cleft lip/palate to correct the defect. This can cause suffering and pain, which could have been prevented if Zofran was never prescribed in the first place.

    Zofran greatly increases the likelihood that a child is born with a cleft lip or cleft palate. A study in January 2012, by Birth Defects Research, reported that women who were prescribed Zofran during the first trimester had a 237% increase in the likelihood of having a baby with a cleft lip/palate (as compared to those who did not take the drug).

  • Heart Defects

    Zofran is continuously being shown to cause an increase in the risk of congenital heart defects at birth. In fact, one study showed that babies born to mothers who took Zofran during pregnancy had a 200% increase in the likelihood of being born with serious heart defects (as compared to mothers who were not exposed to the drug).

    You should consult with a lawyer if your baby was born with heart defects and you took Zofran during your pregancy. The follow conditions are known to be cause by the drug:

    • Heart Murmur
    • Atrial Septal Defect
    • Ventricular Septal Defect

    When child is born with heart defects, the child can require many years of specialty care, and create long-term health problems that can be life-long. Since GSK failed to give proper warnings about Zofran causing heart defects, the company can be held responsible for those defects.

  • Musculoskeletal Defects

    Zofran has been known to cause musculoskeletal abnormalities in children birthed by mother’s exposed the drug. The term “musculoskeletal abnormality” is a very broad term that describes birth defects that affect either a baby’s muscular system or its skeletal system. These abnormalities can affect the baby’s arms, legs, facial structure, spine, or trunk. These conditions range in severity, from very minimal complications, to a lifetime of significant pain and difficulties. Depending on the situation, some of the musculoskeletal abnormalities can be corrected by surgery, and others may be permanent defects.

    In one study, conducted by the Toronto Star in 2014, several babies suffered musculoskeletal abnormalities in which the mother had been prescribed Zofran. One of the cases in that study led the researchers to believe that Zofran was the cause of a baby born with a mouth deformity, jaundice, a heart murmur, and an atrial septal defect.

  • Kidney Defects

    When women take Zofran during pregnancy to help with morning sickness, their babies can be born with developmental issues in the kidneys. Kidney defects have been associated with the drug, and can cause one or both of the kidneys in babies to not function properly. Additionally, Zofran can cause an internal abnormality that prevents proper urine flow, causing the urine to back up into the kidneys. This condition is known as hydronephrosis, and can also cause irreversible damage to the urinary tract.

    Another kidney birth defect caused by Zofran is known as reflux. Kidney reflux happens because the connector of a baby’s ureter and bladder aren’t functioning properly, and causes urine to wash back up into the kidneys. In one study, at least twenty women who had been prescribed Zofran gave birth to a baby with kidney defects, including two of those cases resulting in infant deaths.

  • Fetal Death

    The most serious complication of taking Zofran during pregnancy results in fetal death. These deaths occur when the above complications are so severe the baby isn’t able to survive. While Zofran may not always be the cause of the death, there is strong evidence suggesting that the drug can cause these deaths.

    Zofran was never approved to treat pregnant women, and has been prescribed off-label. Even without the approval, GlaxoSmithKline still marketed the drug as a treatment for severe morning sickness, all while ignoring the possible birth complications.

Contact Gottesman & Hollis

Gottesman & Hollis will consult with you on the issues involving birth defects, complications, and fetal deaths associated with Zofran. If you believe that your child was harmed due to you being prescribed Zofran, please contact us to explore your legal options. We will consider taking your case on a case-by-case basis, and representing you individually, as opposed to a large class-action lawsuit.

By Gottesman & Hollis, P.A. | December 16, 2015 | News

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