Zofran NOT Approved for Use In Pregnant Women
Zofran (ondansetron), made by GlaxoSmithKline (GSK), has been on the market since 1991. It works by reducing the effects of serotonin, which is known to cause nausea and vomiting.
Originally approved as an anti-nausea drug for chemotherapy and surgery patients; GSK saw another, unapproved use for the drug: easing morning sickness in pregnant women.
It is important to know that the FDA has never approved Zofran for use in pregnant women and classifies the drug as a “Pregnancy Category B” medication, meaning that it is unknown whether the drug is safe to take.
Is Zofran Responsible for your Baby’s Birth Defect?
The attorneys at Nash & Franciskato are investigating potential lawsuits on behalf of mothers prescribed Zofran during their first trimester of pregnancy and who gave birth to children with birth defects.
Recent studies have shown that expecting mothers who took Zofran are at a higher risk for delivering children with birth defects such as:
- Heart defects, including Atrial Septal Defects, Ventricular Septal Defects and heart murmurs
- Craniofacial defects, including cleft palates and cleft lips
- Kidney malformations
- Musculoskeletal defects
- Fetal growth restriction (poor growth in the womb)
- Club foot
- Skull deformities
Studies Linking Zofran to Increased Risk of Birth Defects
January 2012, Researchers found that pregnant women who took Zofran or its generic form for morning sickness were at a higher risk of giving birth to children with craniofacial defects.
February 2013, a study published in the New England Journal of Medicine looked at data from Denmark and found no association between Zofran and birth defects; however, other researchers looked at the same data using more pregnancies and a longer time period and found that women who took Zofran during the first trimester were at an increased risk for giving birth to children with major congenital heart defects.
December 2014, The Toronto Star reported that heart defects and other birth defects have been linked to the use of Zofran during pregnancy, finding 20 cases where Canadian women were treated for morning sickness with Zofran and gave birth to children with heart defects and kidney malformation.
March 19, 2015, The FDA warns about heart problems from Zofran, which could be very serious for pregnant women with electrolyte imbalances due to severe morning sickness.
July 17, 2015, the FDA has received 475 reports of birth defects and other fetal adverse outcomes linked to Zofran since it was approved in 1991.
GSK Settles Civil Suit
Accused of marketing several medications, including Zofran, for off-label use, in 2012 GSK faced a civil suit, paying a $3 billion settlement for the illegal promotion of these medications.
However, pregnant women who took Zofran and who delivered children with birth defects were not compensated through the company’s settlement with the government.
Why File a Lawsuit?
GlaxoSmithKline has a duty to consumers to ensure the drugs it manufactures are safe before being offered to the public. Lawsuits being filed accuse GSK of:
- Failing to determine safety risks before selling the drug
- Failing to warn the public about the drug’s dangerous side effects
- Advertising the drug as a safe treatment for morning sickness even though it was not approved for this use
- Failing to properly evaluate all data and safety information on the drug for use in pregnant women and fraudulently claiming the drug was safe for pregnant women
- Producing a defective drug
Receive a Free Evaluation
It’s time to hold pharmaceutical companies accountable for the drugs they produce. The lawyers at Nash & Franciskato Law Firm are ready to help you take legal action against these companies to obtain compensation for your pain and suffering. Contact the Nash & Franciskato Law Firm for a free, no-obligation case evaluation