February 23, 2015 — A woman who had two children with heart defects after taking Zofran has filed a lawsuit against GlaxoSmithKline (GSK).
The woman, Cheri Flynn, is a resident of Minnesota who used Zofran in the first trimester of two pregnancies to treat morning sickness. She says she never would have used Zofran during pregnancy if GSK had adequately warned about the risk of birth defects.
One child, “B.F.,” was born with a congenital heart defect in 2004. She failed to thrive and was in the bottom 5th percentile for growth compared to other children her age. She had surgery to repair the “hole in the heart” defect in 2011.
In 2006, Ms. Flynn had another child, “T.F.,” also with a heart defect. The girl needed 24-hour monitoring with an electronic alarm that would go off if her oxygen levels got too low. Like her sister, the heart defect stunted her growth and development.
According to the complaint (PDF):
“Until recently, Ms. Flynn did not suspect Zofran as the cause of B.F.’s condition, having never been informed until recently that the safety of Zofran treatment in pregnant women has not been established and that Zofran was never FDA-approved to treat morning sickness.”
In the last few years, several studies have found an association between Zofran and birth defects, including one study that found a doubled risk of heart defects (atrial septal defect or “hole in the heart”) and cleft palate. Another study found a 30% increased rate of birth defects in babies exposed to Zofran.