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Study Finds No Risk of Birth Defects from Zofran


May 16, 2016 — A new study has found no link between the anti-nausea drug Zofran and birth defects when it is used by women with morning sickness.

Out of 952 women with severe morning sickness (hyperemesis gravidarum) who used Zofran, one baby had a cleft palate and five had heart defects. Out of 1,286 women who did not use Zofran, two babies had cleft palate and eight had heart defects.

However, women who used Zofran had fewer miscarriages and pregnancy terminations and higher live birth rates.

The researchers believe the study shows that severe morning sickness causes birth defects — not Zofran — when pregnant women become malnourished and dehydrated due to nausea and vomiting.

The study was published in Reproductive Toxicology. The lead author of the study, UCLA associate researcher Marlena Fejzo, said:

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

At least 260 lawsuits have been filed by women who had babies with birth defects after taking Zofran. They accuse GlaxoSmithKline (GSK) of failing to adequately warn women about the risk of birth defects.

Zofran is a powerful anti-nausea drug for chemotherapy patients. It is not approved for pregnancy-related nausea.

The lawsuits cite several recent studies, including one study that found a doubled risk of “hole in the heart” defects associated with Zofran and another study that found a 2.4-fold increased risk of cleft palate.

The cases are centralized in a federal Multi-District Litigation (MDL No. 2657) in Massachusetts, In Re: Zofran (Ondansetron) Products Liability Litigation (Case No. 1:15-md-02657).

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