April 6, 2015 — The family of a boy who was born with birth defects after his mother used Zofran during pregnancy has filed a lawsuit against GlaxoSmithKline (GSK) in federal court in Alabama.
The boy’s mother was prescribed Zofran to treat nausea during the first trimester of pregnancy. Eight months later, she gave birth to a boy with a chromosomal defect that caused a wide range of birth defects.
According to the lawsuit (PDF), these birth defects include:
- Distended kidney and ureteral disorder
- High narrow pallet
- Seizure disorder
- Extra digits on his hands
- Non-verbal and delayed reactions
Genetic testing on the boy’s parents found no evidence of hereditary chromosomal conditions that could be passed to the boy congenitally. The lawsuit blames Zofran for his injuries. It also accuses GSK of negligence for failing to warn that Zofran is “defective and unreasonably dangerous.”
Numerous studies published in the last few years have shown that Zofran passes through the placenta and increases the risk of cleft palate, heart defects, and birth defects. Even so, GSK has not updated the warning label on Zofran or conducted studies to fully investigate the risk.
Every year, about 1 million pregnant women are prescribed Zofran “off-label” for the treatment of morning sickness. Many of these women do not realize that Zofran is not approved or recommended for use during pregnancy.