CHILD BORN WITH A BIRTH DEFECT CAUSED BY OFF-LABEL ZOFRAN USE?
Zofran (ondansetron) is a pharmaceutical drug prescribed to patients struggling with nausea or vomiting associated with chemotherapy. Physicians have also pushed the drug for off-label (unapproved) use on pregnant women suffering from morning sickness with similar symptoms. In 1991, the U.S. Food and Drug Administration approved the drug only for use in patients suffering symptoms due to chemotherapy treatment, postoperative treatment, or total body irradiation.
Ondansetron is available in oral tablet, disintegrating tablet, and oral solution. Zofran is manufactured and marketed by GlaxoSmithKline, and other generic versions are available on the U.S. market. Ondansetron has several common side effects, including:
Unfortunately, controversy has swirled around ondansetron and its potentially raising the risk of birth defects in pregnant women. No clinical trials have been conducted involving pregnant women taking the drug.
STUDIES LINK BIRTH DEFECTS TO ZOFRAN USE IN PREGNANT WOMEN
In 2013, an analysis of nearly one million pregnancies showed that mothers who took Zofran during pregnancy were 30 percent more likely to have a baby with a major congenital malformation compared to mothers who did not take Zofran. A two-fold increased risk of cardiac birth defects were detected with ondansetron usage.
Another large case study completed by Sloan epidemiology and the Centers for Disease Control and Prevention (CDC) reported a two-fold increase in cleft palate associated with ondansetron usage in the first trimester of pregnancy.
Zofran has yet to be categorized as a category “A” drug, which means that based on adequate and well-controlled human studies, there is no risk to the fetus during any trimester of pregnancy. Physicians continue to prescribe the dangerous drug despite not knowing if the drug will cause life-altering harm to an unborn child or not.
GLAXOSMITHKLINE SETTLES OFF-LABEL MARKETING LAWSUIT FOR $3 BILLION
In 2012, the United States Department of Justice announced that GlaxoSmithKline plead guilty to fraud allegations and failure to report safety data and would set aside $3 billion to settle civil lawsuits pertaining to the illegal marketing of several drugs for off-label, unapproved uses. In addition, GSK provided kickbacks and benefits to physicians that prescribed these drugs, including Zofran.
CONTACT AN EXPERIENCED PHARMACEUTICAL DRUG LITIGATION LAWYER
If you took ondansetron while you were pregnant and your child was born with a birth defect or malformation, contact Thomas J. Henry. Our experienced dangerous drug injury attorneys are available 24/7, nights and weekends to evaluate your claim. Our firm has the legal resources to take on the pharmaceutical giants, bring them to justice, and get you the compensation you deserve. Contact us today.