Issue: Cleft palate and heart birth defects
Zofran Drug Birth Defect Lawsuits
In June of 2018, Law360 reported on “bombshell” allegations in Zofran lawsuits that GlaxoSmithKline employed — but later fired — a small team of specialists to secure hedge fund money and deploy pharmaceutical sales representatives to ask every OB-GYN in the country to prescribe the Zofran anti-nausea drug off-label to pregnant patients. The revelations came as plaintiffs in the suits asked the court to extend the discovery deadline so they could gather more information on what two former product managers reportedly described as a mid-2000s plan to get more than 30,000 doctors nationwide to consider prescribing the antiemetic Zofran to pregnant women who allegedly did not actually need the high-power drug, originally intended for cancer patients.
Earlier Developments in the Zofran Heart Defects Lawsuits
The National Law Journal reported on August 13, 2015 that more than 30 lawsuits have been filed by parents alleging that taking anti-nausea prescription Zofran for morning sickness during pregnancy caused birth defects in their children including congenital heart defects, cleft lip and cleft palate. Lieff Cabraser attorney Sarah London noted,
Zofran is a powerful drug approved only for chemotherapy and post-surgery patients. The manufacturer, GlaxoSmithKline, pushed doctors to prescribe this drug to pregnant women, and as a result, babies have been hurt. Now GSK refuses to take any responsibility. Our team at Lieff Cabraser is fighting to achieve justice for those families who have been hurt. We plan to file new lawsuits shortly and are investigating many more potential claims.
Lieff Cabraser represents parents and their children who developed birth defects linked to prescription drugs taken during pregnancy. These cases include birth defect lawsuits due to the use of the anti-nausea drug Zofran (also sold under the generic name ondansetron).
Sarah London Speaks on Dangerous Zofran Birth Defect Injuries & Lawsuits
Zofran was FDA approved in 1991 to treat nausea from chemotherapy and later expanded for use as a treatment for surgical nausea. Lawsuits allege that the drug has been marketed “off-label” (i.e., promoted in the market for uses not approved by the FDA) by GlaxoSmithKline to obstetricians and gynecologists to prescribe to their pregnant patients to control the pregnancy nausea commonly referred to as “morning sickness.”
Troubling new evidence links Zofran taken during pregnancy with increased risks of certain birth defects including cleft palates, certain heart defects, and other injuries.
Studies on Birth Defect Risks of Anti-Nausea Zofran During Pregnancy
Zofran and Infant Heart Birth Defects
In 2014, the American Journal of Obstetrics and Gynecology published a study highlighting increased risks of serious cardiovascular incidents in pregnant women taking Zofran and discussing conflicting studies that could not rule out similar dangers to the fetus. In addition, in 2013 a Danish study found that in 600,000 pregnancies studied over a seven-year period, where the drug was started earlier than ten weeks into the pregnancy there was a two-fold increase in congenital heart birth defects.
Zofran and Cleft Palate
In January 2012, the Center for Birth Defects Research and Prevention identified a two-fold increased risk for cleft palate associated with exposure to Zofran during pregnancy when taken in the first trimester. There were more than 9,000 pregnant women in the study overall, both cases and controls.
FDA Warning on Use of Zofran During Pregnancy
In July 2014, the FDA issued a safety warning on “serious risks” for mothers associated with taking Zofran, especially in pregnant women with electrolyte imbalance due to severe nausea and vomiting.
In addition, based on recent studies regarding the association between Zofran use in early pregnancy and congenital cardiac malformations and oral clefts (cleft lip and palate), the FDA has strongly cautioned against Zofran’s use in pregnancy.