A powerful medication designed to combat the nausea and vomiting symptoms associated with surgery and cancer treatments like chemotherapy and radiation, GlaxoSmithKline’s popular Zofran drug is also commonly prescribed off-label to pregnant women suffering from extreme morning sickness. However, serious concerns have been raised recently about the safety of Zofran use during pregnancy, as a growing body of research has linked the anti-nausea medication to an increased risk of severe birth defects among babies exposed to the drug in utero. If you took Zofran while pregnant, and your child has suffered from serious birth defects like cleft lip, cleft palate or heart abnormalities, contact an experienced Zofran attorney today for legal help.
Zofran (ondansetron) is a 5-HT3 receptor medication manufactured by GlaxoSmithKline and approved by the FDA in 1991, as a means of preventing nausea and vomiting caused by cancer drug treatment and radiation therapy. In some cases, Zofran is also used as a treatment for nausea and vomiting associated with surgery, and works by blocking one of the body’s natural substances – serotonin – which causes vomiting. In recent years however, doctors have begun to prescribe Zofran off-label to pregnant women suffering from hyperemesis gravidarum, an extreme form of morning sickness characterized by unrelenting, excessive pregnancy-related nausea and/or vomiting that limits adequate intake of food and fluids.
Although Zofran has been on the market in the United States for more than 20 years, it wasn’t until a few years ago that researchers began examining the potential adverse effects of Zofran use in pregnancy. In a study published online by the National Center for Biotechnology Information (NCBI) in 2011, researchers found that pregnant women who took Zofran for morning sickness had double the risk of giving birth to babies with a cleft palate birth defect, a malformation occurring when the tissue that makes up the roof of the baby’s mouth fails to join together completely during pregnancy. Two years later, a study analyzing 900,000 Danish births found a two-fold increased risk of heart defects associated with Zofran use in pregnancy.
As more information comes to light about the potential risk of birth defects associated with fetal exposure to Zofran, attorneys across the country are evaluating Zofran side effect claims, and in 2012, the U.S. Department of Justice ordered GlaxoSmithKline to pay $3 billion to resolve allegations that the drug company paid kickbacks to doctors in exchange for promoting a number of its drugs for off-label uses not approved by the FDA, including Zofran as a treatment for morning sickness. If you believe your child has been adversely affected by side effects of Zofran, including heart malformations, cleft lip or cleft palate birth defects, our consumer advocates at the Consumer Justice Foundation can help put you in touch with a reputable lawyer who has experience handling Zofran birth defect claims.