Zofran, also known by its generic name, ondansetron, is a drug that was approved originally to treat nausea and vomiting after chemotherapy or surgery. Doctors began prescribing off-label use of Zofran and its generic equivalent to treat nausea and vomiting related to pregnancy. The drug, however, was never approved for use during pregnancy to treat morning sickness. Recent studies showed that women who used Zofran during the first trimester of pregnancy were more likely to give birth to a child with heart defects and cleft palates or cleft lip. Suthers & Harper is currently investigating claims on behalf of women who took Zofran in the first trimester of pregnancy and who had a child with heart defects or cleft defects.

There are three types of heart defects associated in newborns whose mothers had used Zofran while pregnant. Those defects include atrial septal defect (ASD), ventricular septal defect (VSD), and heart murmur. A ventricular septal defect is a hole in the wall (the septum) that divides the two lower ventricles of the heart. A newborn with such a defect can have one or more holes in different places in the septum. When this happens, it causes the baby’s heart and lungs to have to work harder than normal. If this condition goes on too long without treatment, it places the baby at risk for heart failure, pulmonary hypertension, arrhythmia (irregular heatbeat), and in some cases, a stroke. Signs of a ventricular septal defect in a newborn include heavy breathing, shortness of breath, extreme fatigue during feeding, and sweating. The symptoms usually correlate to the size of the hole in the septum. While a very small hole in the septum may close on its own, larger holes typically require surgery to repair. Ventricular septum defects can usually be diagnosed by the baby’s physician through a physical examination and diagnostic tests, such as an echocardiogram.

While a congenital heart defect may not be readily apparent at birth, a cleft palate or cleft lip is readily apparent at birth. A cleft lip is a separation of the two sides of the upper lip, which not only affects the appearance of the face, but can also create functional problems. A cleft lip can impair a child’s ability to talk, eat and breathe normally. Children born with cleft palates and cleft lips typically require multiple surgeries, with the goal being to restore normal function of the lip and achieve the best cosmetic appearance possible. It is not unusual for plastic surgeons to have to perform multiple procedures as a child grows older in order to diminish the residual effects, such as scarring and scar tissue.

Originally manufactured by GlaxoSmithKline (GSK), the first generic versions of Zofran (ondansetron) were approved in 2006. Another pharmaceutical giant, Sandoz, marketed the initial generic versions of Zofran. Interestingly, in 2012, GlaxoSmithKline paid $3 billion to settle claims brought against it by the United States Department of Justice, concerning the manufacturer’s marketing of several medications, including Zofran. The government accused GlaxoSmithKline of improperly marketing Zofran as a treatment for morning sickness during pregnancy. Recently, Zofran lawsuits were filed in several Federal courts in the U.S. by women who alleged they had used Zofran during their pregnancies and as a result, their children were born with serious heart defects. Both lawsuits alleged that Zofran was never approved by the Food and Drug Administration for use to treat morning sickness in expectant mothers.

Suthers & Harper is currently offering free case evaluations to any family whose child was born with one of these serious birth defects caused by pre-natal exposure to Zofran, contact us online or call us toll free at 1.800.320.2384.

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