tcf-no-longer-accepting-casesMay 16, 2016 — A new study has found no evidence of an increased risk of birth defects among pregnant women who used the anti-nausea drug Zofran.

Out of 952 women who used Zofran, there were five babies with heart defects and one with cleft palate. Among 1,286 non-exposed babies, eight had heart defects and two had cleft palates.

Women with severe morning sickness on Zofran had fewer miscarriages and pregnancy terminations and higher live birth rates compared to women with severe morning sickness who did not take Zofran.

The study was published by Marlena Fejzo, an associate researcher at UCLA, in Reproductive Toxicology.

“Taking this medication helped them get through their pregnancies and gave them their desired outcome, a live birth,” Fejzo said.

Extreme morning sickness can harm a developing baby when the mother becomes dehydrated or malnourished due to excessive vomiting and lack of appetite. Fejzo said it suggests that morning sickness increases the risk of birth defects — not Zofran.

However, several other studies have specifically associated Zofran and birth defects. One study found a doubled risk of “hole in the heart” defects associated with Zofran. Another study found a 2.4-fold increased risk of cleft palate.

As of today, at least 260 federal lawsuits have been filed against GlaxoSmithKline by women who took Zofran during pregnancy and had a baby with a birth defect. The cases are centralized in MDL No. 2657 in the U.S. District Court for Massachusetts, In Re: Zofran (Ondansetron) Products Liability Litigation (Case No. 1:15-md-02657).


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