Zofran Studies: Link or No Link to Birth Defects?

Pittsburgh, PAWhile Zofran birth defects lawsuits continue to be filed, a recent study has not found a link between the anti-nausea drug and birth defects.

The study, published in Reproductive Toxicology (May 9, 2016) and conducted by the UCLA Department of Medicine, went so far as to suggest that women who took Zofran during their pregnancy were less likely to suffer a miscarriage or stillbirth.

Titled “Ondansetron [Zofran] in pregnancy and risk of adverse fetal outcomes in the United States,” data was collected on 1,070 women who took Zofran during their pregnancy and compared outcomes to two control groups. Researchers found the following:

• Five heart defects and one cleft palate among 952 infants whose mothers took Zofran during pregnancy.
• Eight heart defects and two cleft palates were reported among the 1,286 infants born to women who did not take Zofran during their pregnancy for morning sickness.

Marlena Fejzo, an associate researcher at the David Geffen School of Medicine at UCLA, said that she believes “this data is critical to guide future decision-making regarding prescribing…one of the most effective and most commonly prescribed off-label treatments for nausea and vomiting.” Fejzo herself suffered severe morning sickness during two pregnancies.

But two previous studies found that Zofran may increase risk of heart defects and cleft palate in children exposed in utero. Although this current study - like the other two studies - can help women make informed choices about whether to expose their fetuses to the medication, it may prove difficult for women to reach a decision. A number of women have such violent nausea and vomiting that it could cause detached retinas, blown eardrums, cracked ribs and torn esophagi. Some women require hospitalization with IV fluids and feeding tubes.

Meanwhile, Massachusetts Judge Saylor issued a court order finalizing a timeline in the Zofran Multi-District Litigation (MDL) 2657 in Boston, where more than 230 lawsuits have been consolidated. The first Zofran lawsuit was filed in 2015 by a Minnesota woman on behalf of her two daughters, both of whom were born with congenital heart defects. The manufacturer, GlaxoSmithKline, tried to have the lawsuits dismissed, but Judge Saylor denied this motion.