The U.S. Food and Drug Administration has issued a warning against Zofran (Ondansetron) use for treating morning sickness in pregnant women. Zofran was approved by the FDA to prevent nausea related to chemotherapy treatments in cancer patients. However, Zofran has been prescribed off-label to pregnant women to help treat morning sickness.
Zofran was not tested for use in pregnancy and preliminary studies reveal a link to Zofran and birth defects. Lawsuits claim that GlaxoSmithKline, Zofran’s drugmaker, knew there were dangers associated with Zofran for developing babies, yet continued to market its use to treat morning sickness.
According to lawsuits, birth defects linked to Zofran use are:
- Heart defects
- Cleft lips
- Cleft palates