Zofran Blamed as Cause for Cleft Palate in New Lawsuit

On October 3, 2016, a mother claimed that the active ingredient in the anti-nausea drug Zofran’s caused her son to develop cleft palate and cleft lip in the womb. The woman, from Oneida, New York, filed her case in the U.S. District Court of Massachusetts, where more than 280 additional Zofran lawsuits are currently consolidated.

In 2012, researchers at Harvard and Boston University discovered that women prescribed Zofran for nausea during pregnancy were more than twice as likely to deliver children with a cleft palate. Zofran’s warning label, however, does not mention a potential increased risk for cleft palate.

In this most recent complaint, the mother maintains that she was prescribed a generic version of Zofran for her first and second trimesters. Her son, now 4 years old, was born with “a cleft hard palate [and] unilateral right cleft lip,” court records report. The mother is demanding a total of $10 million in compensation, saying that she and her son have suffered “severe and permanent pain and suffering mental anguish [and] medical expenses.”

Zofran’s active ingredient has never been approved for use during pregnancy, but nonetheless, it has become a popular choice among obstetricians to prescribe the drug for its anti-nausea effects to treat morning sickness.

The U.S. Department of Justice allegedly suggests that GlaxoSmithKline may have marketed Zofran as an “off-label” morning sickness treatment, in violation of federal law. Families from all over the country have renewed this allegation in more than 280 lawsuits, accusing GlaxoSmithKline of promoting a drug, one with links to birth defects, directly to gynecologists and obstetricians.

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