2012 MotherRisk Update: Zofran Can’t be Assumed Safe for Pregnancy

Published on March 23, 2015 by Sandy Liebhard

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While Zofran birth defect lawsuits are only beginning to mount in U.S. courts, an organization called MotherRisk was cautioning against its use in pregnant women as early 2012. According to an article published that year, the group was unable to conclude that ondansetron, which is sold under the Zofran brand name, could be safely used in pregnancy.

Created in 1985, MotherRisk is a clinical research and teaching program at The Hospital for Sick Children in Toronto, Canada that provides information and guidance to expectant and breastfeeding mothers, as well as healthcare providers. The organization is primarily focused on protecting unborn babies from exposure to drugs, chemicals, diseases, radiation and environmental agents, and maintains several dedicated toll-free numbers to provide pregnant women with advice on various issues, including morning sickness treatments.

Zofran Pregnancy Data

According to an abstract posted on the MotherRisk website in October 2012, Zofran has been increasingly used in the U.S. to treat nausea and vomiting related to pregnancy. However, the medication hasn’t been approved by the Food & Drug Administration (FDA) for this use, and the Zofran label clearly states that there have not been adequate, well-controlled studies of its effects on a developing pregnancy.

Among other things, MotherRisk pointed out that fetal safety data for ondansetron are based on fewer than 200 births. The article further noted that this sample size ruled out only a 5-fold increased risk of major malformations, and not any specific birth defects. The report also cited a later study, which was conducted by the scientists at the Slone Epidemiology Center in Boston, Mass, and the Centers for Disease Control,that had suggested an association between Zofran and cleft palate among children born to women who were prescribed the medication to control nausea and vomiting during their pregnancy.

“Based on the data available today, ondansetron use cannot be assumed to be safe during pregnancy,” the report concludes.

Since MotherRisk issued its 2012 warning, a number of other studies have linked prenatal use of Zofran to birth defects, including serious heart malformations. In August 2013, for example, research presented at a meeting of the International Society of Pharmacoepidemiology suggested that Zofran was associated with a 30% increased risk of birth defects overall, and a two-fold increased risk of heart abnormalities. In December 2014, a study published in Reproductive Toxicology suggested that Zofran could double the risk that a child will be born with septal heart defects, including atrial septal defects and ventricular septal defects.

Learn About the Process for Filing a Zofran Lawsuit

In recent months, Zofran birth defect lawsuits have begun to mount in courts around the U.S. If you believe your baby was harmed by this drug, please contact Bernstein Liebhard LLP today for a free, no-obligation review of your case. Our Zofran lawyers will explain all your legal options, so that you can decide the best way to proceed for you and your child. Call

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