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March 25, 2015

Concerns about Zofran for expectant moms

by: Kimberly Barone Baden

It’s not as if expecting mothers don’t have enough to be worried about—from trying to purchase the safest possible car seat and products for the newest member of the family, to doing what you can to stay healthy and nurture your growing baby, there’s always some kind of concern or question on your mind. I know when I was expecting my daughter I was a bit overwhelmed by all the books and advice being offered. And as if all of this isn’t enough, some expecting mothers also experience severe morning sickness and turn to their doctor for help in finding relief, such as through prescription medications like Zofran. Of the 80 percent or so of pregnant women who suffer from morning sickness, roughly two percent are diagnosed with hyperemesis gravidarum, a severe form of morning sickness that leads to more than 50,000 hospitalizations each year. We are now learning more about the prescription medication Zofran, which is being prescribed off-label to pregnant women suffering from severe morning sickness, and I have many concerns about it being prescribed as recent studies show that exposure to this drug suggests an increased risk of birth defects in children.

Zofran and morning sickness

In 2012, the manufacturer of Zofran, GlaxoSmithKline (GSK), was fined an unprecedented $3 billion for the “unlawful promotion of certain prescription drugs,” among other charges, making this “the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.” Among the drugs specifically called out by the U.S. Department of Justice were two that have been linked to birth defect risks in unborn children: the antidepressant Wellbutrin and Zofran. In the roughly quarter-of-a-century that Zofran has been around, it has never been approved for anything other than the prevention of “nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery.” In its settlement with GSK, the U.S. Department of Justice resolved allegations “that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women” and “paid kickbacks to health care professionals to induce them to promote and prescribe these drugs.” This off-label use became even more of a concern as research studies began to link the use of ondansetron (the generic name for Zofran) with a doubling of the risk for babies born with cleft palate. In 2013, a large Danish study looking at close to 1 million births showed a two-fold increase in babies born with heart defects where the mother reported taking ondansetron. And in Canada, a report found that at least 20 women treated with ondansetron in 2012 reported serious suspected side effects, including two infant deaths, with one doctor reporting “that ondansetron was the suspected cause of a baby’s mouth deformity, jaundice, heart murmur and two heart defects.” As a mother, I wanted to share this concerning information. As my team continues to learn more about Zofran and other potentially harmful prescriptions for pregnant women, we’ll make sure to provide updates.