What Are the Birth Defects Related to the Use of Zofran?

Published on April 28, 2015 by

Kidney Problems and Beyond

A study published by Australian researchers, Off-Label Use of Zofran (also technically known as “Ondansetron”) in Pregnancy in Western Australia, found that babies born to women who used Zofran during the first trimester had a 20% higher likelihood of being born with medical problems, including kidney defects, malformation of the ureter and hydronephrosis. The researchers said (bold ours):

"This study could not conclude that ondansetron is safe to use in pregnancy, given the small but potentially clinically important increases in several measures of outcome investigated. After adjusting for potential confounders, we found an increased risk of a major birth defect (1.2; 0.6–2.2), preterm birth (1.4; 0.7–2.5), shorter birth length (1.4; 1.0–1.8), and maternal urinary tract infection (1.6; 0.9–2.7).”

Septal Heart Defects

In another association study published in December 2014 in Reproductive Toxicology -- Use of ondansetron during pregnancy and congenital malformations in the infant -- researchers examined association data from 1,349 Swedish mothers who took the anti-nausea drug during their pregnancies and found the following:

“If an association between use of ondansetron and an increased risk for cardiovascular defects is true, the strongly increasing off label use of the drug at nausea and vomiting in early pregnancy must be regarded as unsuitable and should be avoided... a risk increase of cardiovascular malformations and notably septum defects may exist and we suggest that the drug should not be used off label for nausea and vomiting in early pregnancy until further large prospective studies are available.”

It’s important to remember that studies like the two we’ve just discussed are epidemiological – that is, they’re looking at associations between particular phenomena and results. Associations do not necessarily prove causation, as any logician will tell you. And as these Swedish authors themselves noted in their conclusion: “a final answer to the question of moderate teratogenicity [causing birth defects] is seldom obtained from one study… repeated studies are needed.”

In our next post, we’ll take a look at the evidence linking the drug with these problems and the debates surrounding the use of this drug on pregnant women.

To explore the possibility of bringing legal action right away to obtain compensation for Zofran-related birth defects, please call the experienced attorneys here at Marc Whitehead & Associates, LLP at (855)-423-3666. For more information regarding Zofran please download a copy of our free E-book, The Zofran Tragedy.