The makers of a drug tied to cleft lips and other birth defects alleged in Zofran lawsuits admitted last year that it has not been proven safe for use in pregnant women, the Toronto Star reported.

Among other things, GlaxoSmithKline said in a statement published by the Canadian outlet on June 25, 2014 that “the safety of ondansetron for use in pregnancy has not been established,” despite the fact that it is often prescribed to treat hyperemesis gravidarum, a condition referring to extreme nausea. The Toronto Star delved into the known risks associated with Zofran, which is approved by the U.S. Food and Drug Administration (FDA) to treat chemotherapy and surgery patients, and pointed to a 2011 study that looked at its potential to cause cleft palates. Researchers found that babies exposed to Zofran in the womb were twice as likely to be born with this complication. Findings were supported by complaints logged in the FDA’s Adverse Event Reporting System (AERS) database, the Toronto Star found, but not in reports filed with Health Canada, the country’s regulator.

2013 Study Finds Two-Fold Risk of Zofran Heart Defects

Two years later, a Danish study published in the New England Journal of Medicine analyzed 900,000 births and found a two-fold increase in heart problems associated with Zofran. The more births they included as research went on, the same conclusions were reached.

The findings of research published in a January 2012 issue of the journal Birth Defects Research found that women exposed to Zofran were 2.37 times more likely to have a baby with an oral cleft than those who did not take the drug. Data form 9,000 pregnancies included in the investigation, which was called the National Birth Defects Prevention Study, looked at 9,000 pregnancies.

Birth defects allegedly caused by Zofran likely occur if the medication is used during the woman’s first trimester of pregnancy, which is the most crucial period of fetal development.

Was Your Baby Harmed by Zofran? Call our Firm Today.

If you believe your baby was born with a Zofran birth defect, the time is now to call an attorney at our Firm for legal advice. Our attorneys are investigating potential claims on behalf of children who may have been harmed by this medication in the womb. Speak with a Bernstein Liebhard LLP attorney directly at (888) 881-3077.

Published March 3, 2015 by