Many pregnant women have taken Zofran (ondansetron) to treat morning sickness, vomiting and nausea occurring during pregnancy. However, research has linked the prescription drug to serious birth defects that include cleft palates, heart defects and other crippling conditions. As a result, many women who took the drug during pregnancy have filed suit against the pharmaceutical company and their doctors for failing to warn them of the potential risks to their unborn child. Glaxo Smith Kline is the pharmaceutical manufacturer and distributor of Zofran.
Zofran has been proven highly effective for treating nausea and other symptoms of morning sickness. However, prescribing the medication for treating morning sickness is considered an “off label” use of the drug, and does not have the approval of the Food and Drug Administration. Without FDA approval, no conclusive clinical studies have been conducted on pregnant women to determine if any contraindications or side effects were produced in the mother or fetus.
Originally, Glaxo Smith Kline marketed the medication for patients undergoing chemotherapies and surgeries that produced unbearable nausea as a way to control the pain. However, because the pharmaceutical company is a “for profit” corporation, their marketers took steps to purposely push the medication for off label use.
As a result, the U.S. Justice Department ordered Glaxo Smith Kline to pay $3 billion in fines for illegally marketing numerous prescription medications for off label use, including Zofran. Some of the fines by the Justice Department order were to punish GSK for paying kickbacks to doctors prescribing the medication for off label use.
Glaxo Smith Kline conducted a variety of studies on animals in the 1980s that indicated Zofran in fact did cross the placenta from the mother to the fetus. In the last 10 years, numerous studies confirmed the prescription medication rapidly passes in “significant amounts” from human mothers to their child through the placenta. These studies also indicate that the medication tends to remain active much longer in the fetus than in the mother.
The New England Journal of Medicine published a study on Zofran in 2013 reassuring the public that the prescription drug was not increasing the potential risks of birth defects in humans. However, approximately 50 percent of all female study participants only took the medication 10 weeks and longer into their pregnancy, when the risks of major birth defects including heart defects and cleft palates were significantly reduced.
Within months after the published study was released, other researchers studied the same data showing pregnancy outcomes. The team reached the conclusion that the prescription medication had actually doubled the potential risks of creating heart defects in babies, which leads to a 30 percent increase risk. The study concluded that one out of every 20 newborns exposed to Zofran were actually born with a birth defect. This is significantly higher than the one out of every 28 newborns born with birth defects that were not exposed to the drug.
Common Birth Defects
A large study was conducted in 2013 involving 900,000 pregnancies where approximately 1250 expecting mothers from the group took the prescription medication during their first trimester. The results showed that the risk for developing heart defects was approximately 2 to 1 for infants exposed to Zofran. Common defects associated with the drug include:
- Atrial Septal Defect (ASD), also referred to as a “hole in the heart”
- Ventricular Septal Defect (VSD), or a hole between two ventricles (lower chambers) of the heart
- Heart Murmur
- Cleft Palate where the roof of the mouth is split
- Cleft Lip where the upper lip is split
- Kidney Malformation
- Mouth Deformity
- Fetal Growth Restriction
- Musculoskeletal Abnormality
- Fetal Death
Families with a baby born with a birth defect after the mother took Zofran (ondansetron) while pregnant should consider filing a lawsuit to hold those legally responsible accountable for their negligence. This is because the mother more than likely was never told of the potential risks of taking the prescription medication because their doctors and/or Glaxo Smith Kline concealed the truth about the harmful and devastating side effects of the prescription medication. Personal injury attorneys handling Zofran lawsuits are seeking compensatory and punitive damages in an effort to warn other pregnant women of the dangers involved in using the drug.