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Zofran Birth Defect Lawsuits

Zofran, an anti-nausea drug frequently prescribed to pregnant women, may cause abnormal fetal heart development, and the families of over 600 children born with heart defects have sued the makers of Zofran, alleging that exposure to the drug in utero was the cause of the birth defects.

Frequent nausea and vomiting, sometimes called morning sickness, is a common symptom of pregnancy, but finding a safe and effective remedy for it has been elusive. The most severe form, known as hyperemesis gravidarum, is just as hard to treat. The pharmaceutical industry has a troubled history with drugs prescribed to pregnant women to reduce nausea and vomiting. Even though it has been off the market since the 1960s, thalidomide remains the classic example of a drug known to cause birth defects; it was also highly effective at treating pregnancy-related nausea. Drug manufacturers withdrew the other leading morning sickness drug, Bendectin, from the market in 1983 amid lawsuits alleging that it caused malformation of many different organ systems in the developing fetus, despite that research has never conclusively linked the drug to any fetal abnormalities. Since the early 1990s, ondansetron, sold under the brand name Zofran in the United States, has been widely prescribed off-label to treat nausea and vomiting in pregnancy. Families are now alleging that the drug caused their children to be born with heart abnormalities. If your child was born with heart problems after you took Zofran during pregnancy, a Palm Beach County mass torts lawyer can help you pursue justice.

Is Zofran Safe for Pregnant Women?

The Food and Drug Administration (FDA) approved Zofran in 1991 as an anti-nausea drug, but its intended use was for cancer patients who were suffering from nausea and vomiting as a side effect of chemotherapy or radiation. Soon, obstetricians began prescribing it to pregnant women suffering from pregnancy-related nausea and vomiting, despite the fact that the FDA never declared it safe for this category of patients. In fact, its popularity increased until, by 2013, doctors were writing 110,000 Zofran prescriptions per year for pregnant women. Seeing the drug’s popularity as a morning sickness treatment, the drug manufacturer, GlaxoSmithKline, began to market it for that purpose, despite the lack of FDA approval and the reports of children with heart abnormalities being born to mothers who had taken Zofran during pregnancy.

As of 2021, plaintiffs have named GSK as a defendant in at 600 federal lawsuits alleging that exposure to Zofran in utero caused children to be born with heart defects serious enough for the children to require surgery shortly after birth. The plaintiffs claim that GSK acted negligently by marketing Zofran to obstetricians and to pregnant patients, especially given that animal studies conducted before 2013 showed that the drug was not safe for use in pregnancy.

Contact Ged Lawyers About Zofran Product Liability Lawsuits

A mass torts lawyer can help you recover damages if your child was born with heart defects or other congenital abnormalities after you took Zofran during pregnancy. Contact Ged Lawyers in Boca Raton, Florida to discuss your case.