The birth of a child should be a joyous event, but a birth defect can lead to a lifetime of worry, stress and grief.
Although some birth defects have no known or preventable cause, others may be linked to environmental factors or the use of certain medications.
A 2014 study published in the American Journal of Obstetrics and Gynecology found 97.7% of prescriptions written for nausea and vomiting during pregnancy are NOT approved for use during pregnancy. In particular, the popular anti-nausea medicine Zofran has been the subject of FDA warnings and scientific research linking it to birth defects.
- The Center for Birth Defects Research and Prevention found ondansetron, the generic form of Zofran, is associated with a twofold increase in the risk of cleft palate when taken during the first trimester of pregnancy.
- Danish researchers found there was a twofold increase in congenital heart defects when ondansetron is used during the first trimester.
- The FDA issued a warning that the use of Zofran may be associated with abnormal heart rhythms and may potentially increase the risk of serotonin syndrome.
Zofran is not approved for use in pregnancy and yet many physicians had prescribed the drug for morning sickness, a practice known as “off-label use.”
In 2013, GlaxoSmithKline pled guilty to civil and criminal charges regarding how it marketed several drugs, including Zofran. The company paid $3 billion to settle claims that, among other things, it encouraged physicians to prescribe the drug to pregnant women and offered kickbacks to professionals that did so.
GlaxoSmithKline has settled with the government, but the company is facing a class action lawsuit from parents who have children with birth defects that may be related to the use of Zofran.
If you took Zofran while pregnant and have a child with a birth defect, you may want to discuss your options with a legal professional.