Another Zofran lawsuit has been filed against GlaxoSmithKline alleging that the drug causes birth defects. G.K., a male child, was born without one kidney. He is also missing the connective tissues that would make a kidney transplant possible. Other birth defects include a deferens that is not fully functional, a defect that may limit G.K.’s sexual function as an adult and make it impossible for him to father a child.
The popular anti-nausea drug Zofran (ondansetron), often prescribed for morning sickness, is in the news and the courts again. Angela and Bryan K. recently filed suit claiming that their baby was born with one kidney due to Zofran use. The infant, identified only as G.K., has other birth defects, too.
The suit alleges that GlaxoSmithKline (GSK), Zofran’s maker, failed to adequately warn the plaintiffs of the risk of birth defects. Angela used the drug during her first trimester. G.K. was born in 2007 with a condition known as unilateral renal agenesis. Sadly, he was also born without the connective tissues needed for a kidney transplant. None of this was discovered until 2013, when then six-year-old G.K. was injured in an accident. The injury damaged his kidney leaving him with 38% kidney function.
This damage, and the impossibility of a kidney transplant, creates future difficulties for G.K., including the possibility of dialysis. On top of the missing kidney, G.K.’s parents claim that he was born without a fully functional deferens (part of the male reproductive system). If this claim is true, G.K. will likely be unable to father a child by natural means. It also means he may not have normal male sexual functionality. At this point, G.K. is too young to determine if this is the case.
While Zofran has FDA approval for use treating nausea, that approval is limited to cancer and surgery patients. The drug is not FDA approved for treating morning sickness making such use an “off-label” prescription. Zofran is still commonly prescribed for morning sickness, though.
Several suits have been filed alleging that Zofran causes birth defects, but this is the first claiming kidney related birth defects. The others involve heart defects and babies born with cleft lip or cleft palate. The suits allege that GSK actively marketed Zofran for this “off-label” use despite knowing the risks.