Approved to treat: Nausea and vomiting
Drug category: serotonin 5-HT3 receptor antagonist
Year approved: 1991
Studies suggest that babies exposed to Zofran in the first trimester of pregnancy are at an increased risk of the following birth defects:
Study: Zofran Doubles Risk of Birth Defects
Zofran is not approved by the Food and Drug Administration to treat morning sickness in pregnant women, but this is a common off-label use. Yet a 2012 study documented a 2.37x increased risk of cleft palate defects in babies exposed to Zofran. Further, when Danish researchers examined nearly 100,000 births, they found that babies exposed to the drug in the first trimester were twice as likely to suffer a heart defect.
Manufacturer GlaxoSmithKline has paid billions in fines for marketing its drugs for off-label uses and for giving kickbacks to doctors who prescribe them. The company needs to be held accountable for any harm caused by its products.
If your baby was harmed by Zofran, our attorneys may be able to get your family what you need to move past this. Contact us today.