One lawsuit recently filed by the parents of two children who were born with birth defects, alleges both children’s birth defects were linked to the use of Zofran while the mother was pregnant. Furthermore, the lawsuit alleges, GlaxoSmithKline did not carry out a single study to determine whether Zofran would affect a growing fetus or pregnant mother before it began marketing Zofran for off-label use.
“GSK knew as early as 1992 that Zofran passed through the placenta and into a developing fetus,” the lawsuit alleges.“GSK knew as early as 1992 that Zofran presented ‘unreasonable risk of harm’ to developing babies because the drug passes through the human placenta.” Despite having this information - the lawsuit claims that by 2000, GlaxoSmithKline had 32 reports of birth defects linked to Zofran - GlaxoSmithKline marketed the drug to pregnant women through 2011. Among the reported side effects were congenital heart defects, intrauterine death, stillbirth and kidney malformation.
Although it is not illegal for doctors to prescribe medications off-label, it is illegal for companies to market their drugs for uses not approved by the FDA. Zofran is approved to prevent nausea and vomiting linked to chemotherapy, radiation or surgery. In 2012, the US Department of Justice announced that GlaxoSmithKline would pay more than $1 billion to settle claims concerning the illegal marketing of Zofran and other medications.
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Those risks, according to the lawsuit, include 2.37 times the risk of cleft palate, twice the risk of a heart defect and 20 percent increased risk of any birth defect. However, not all studies have found a link between the use of Zofran and the risk of major birth defects. A 2013 study published in The New England Journal of Medicine (2/28/13) found no significantly increased risk of spontaneous abortion, stillbirth or major birth defects when pregnant women used Zofran.
The lawsuit is Hill v. GlaxoSmithKline, case number 1:15-cv-00637-UNA, filed in US District Court for the District of Delaware.