UCLA Study: No Evidence Linking Anti-Nausea Drug Zofran To Birth Defects

LOS ANGELES (CBSLA.com) — There's no evidence that taking the anti-nausea drug Zofran while pregnant leads to an increased risk of birth defects, according to a new study authored by a UCLA researcher.

The study, published Monday in the journal Reproductive Toxicology, comes after two other studies found the drug may increase the risk of heart defects and cleft palate in children exposed to the drug in utero.

Marlena Fejzo, an associate researcher in the David Geffen School of Medicine at UCLA who authored the study, found that women who took Zofran reported fewer miscarriages and pregnancy terminations and higher live birth rates than women with extreme morning sickness who did not take the drug.

"We did not see any increased risk of birth defects," Fejzo told KCAL9's Kristine Lazar.

Pregnant women suffering from extreme morning sickness often look to the drug for relief. Symptoms of extreme morning sickness can include continuous nausea and vomiting so violent that women can suffer from detached retinas, blown eardrums, cracked ribs and torn esophagi.

But concerns about the impacts of the drug on fetuses are widespread. More than 190 lawsuits have been filed in 2015 against the drug's manufacturer, GlaxoSmithKline, alleging birth defects from Zofran exposure.

Ferzo suffered from extreme morning sickness during her two pregnancies and was prescribed Zofran.

"It was torture," she said of her experience. "I would just stare at the wall."

Her experience guided her into researching the drug. She said she hopes the results of her study help doctors and patients make informed decisions on treatment.

"I believe this data is critical to guide future decision-making regarding prescribing what is one of the most effective and most commonly prescribed off-label treatments for nausea and vomiting," she said in a statement. "The overall results do not support an increased risk of birth defects."

In the study, data was collected on 1,070 pregnant women exposed to Zofran and compared to outcomes in two control groups, 771 pregnancies in women with a history of extreme morning sickness with no Zofran exposure and 1,555 pregnancies with neither a history of extreme morning sickness nor Zofran exposure.

The study's data revealed that heart defects were reported in five of 952 infants in the extreme morning sickness/Zofran-exposure group and in eight of the 1286 infants born to women who did not have extreme morning sickness and were not exposed to Zofran.

Cleft palate was reported in one of 952 live births in the extreme morning sickness/Zofran-exposure group and in two of 1286 in the women who did not have extreme morning sickness and did not take Zofran.

"What was really significant to me was that women with extreme morning sickness who took Zofran reported fewer miscarriages and terminations and experienced higher live birth rates," Fejzo said in a statement. "Taking this medication helped them get through their pregnancies and gave them their desired outcome, a live birth."

"This study suggests that having a history of (extreme morning sickness), not the exposure to Zofran, may be associated with an increased risk of birth defects," she said. "Women have to weigh the evidence of the efficacy of one of the most effective drugs for nausea and vomiting against the risk of birth defects. Women and their babies need nutrition during pregnancy, and if they have less nausea and vomiting that goal may be accomplished."

Fejzo has twin daughters, and she feels a responsibility to conduct further research on extreme morning sickness on their behalf.

"It would be devastating to see my daughers go through what I did, and I know i didn't do everything in my power to try to make things better."

The study was supported, in part, by the Hyperemesis Education and Research Foundation and the Janice and Paul Plotkin Family Foundation, the university said.