New Study Suggests No Link between Zofran and Birth Defects

Los Angeles, CAA new study conducted by researchers at UCLA suggests there is no link between Zofran and birth defects. The study comes as more women are filing lawsuits alleging their infants suffered serious Zofran side effects after exposure in the womb. It also contradicts previous research that suggested a link between the anti-nausea medication and birth defects. Among the side effects alleged in the Zofran lawsuits are an increased risk of heart defects and cleft palate.

Zofran is an anti-nausea medication approved to treat nausea and vomiting linked to cancer treatments. Doctors often prescribe the medication off label to treat morning sickness in pregnant women. But some studies suggest the use of Zofran while pregnant can increase the risk of having an infant with birth defects.

A new study conducted by researchers at UCLA and published in the journal Reproductive Toxicology (7/16) did not find a link between ondansetron (the generic name of Zofran) and birth defects. Researchers led by Marlena Fejzo examined data from 1,070 pregnancies in which pregnant women who suffered from Hyperemesis Gravidarum (HG) were treated with Zofran. There were 771 pregnancies in which women who had HG were not treated with Zofran and 1,555 pregnancies in which women did not have HG and were not treated with Zofran.

They found that women in all three groups had similar rates of ventral septal defects and cleft palate.

“Women with a history of HG who took ondansetron reported less miscarriages and terminations, and higher live birth rates,” the authors wrote. They concluded that the study does not support evidence that Zofran is harmful to unborn babies.

HG is a serious condition in which women suffer from continuous nausea and vomiting. That vomiting can cause other health problems in women, including cracked ribs, according to UCLA. Lead researcher Marlena Fejzo said in a news release that the study suggests it is HG and not the Zofran itself that could be linked to an increased risk of birth defects.

The study, however, contradicts previous research that suggested a link between the use of Zofran during pregnancy and an increased risk of birth defects. One such study was presented at the International Society of Parmacoepidemilogy in 2013 and found that Zofran was linked to an increased risk of birth defects. It further found that the same risk was not seen in a similar morning sickness medication.

As of May 16, 2016, there were 260 lawsuits consolidated for pretrial proceedings in MDL-2657 In re: Zofran (ondansetron) Products Liability Litigation. Lawsuits have also been filed in Canada alleging women were not adequately warned about the potential link between Zofran and birth defects.