Personal Injury

Zofran Birth Defects

Issue: Cleft palate and heart birth defects

Zofran Drug Birth Defect Lawsuits

The National Law Journal reported on August 13, 2015 that more than 30 lawsuits have been filed by parents alleging that taking anti-nausea prescription Zofran for morning sickness during pregnancy caused birth defects in their children including congenital heart defects, cleft lip and cleft palate. Lieff Cabraser attorney Sarah London noted,

Zofran is a powerful drug approved only for chemotherapy and post-surgery patients. The manufacturer, GlaxoSmithKline, pushed doctors to prescribe this drug to pregnant women, and as a result, babies have been hurt. Now GSK refuses to take any responsibility. Our team at Lieff Cabraser is fighting to achieve justice for those families who have been hurt. We plan to file new lawsuits shortly and are investigating many more potential claims.

Lieff Cabraser represents parents and their children who developed birth defects linked to prescription drugs taken during pregnancy. These cases include birth defect lawsuits due to the use of the anti-nausea drug Zofran (also sold under the generic name ondansetron).

Lieff Cabraser has been recognized by U.S. News, Best Lawyers, and the National Law Journal as one of the top plaintiffs’ law firms in the nation. Please contact us by completing the contact form below or calling us toll-free at 1 800-541-7358.

Contact a Zofran Birth Defect Lawyer

If you have been prescribed Zofran/ondansetron for use during pregnancy, and your child was born with birth defects, we welcome the opportunity to speak with you. We will promptly review your case for free, confidentially, and in a caring, compassionate manner.

Alternatively, you may call us toll-free at 1 (800) 541-7358 and ask to speak to attorney Sarah London.

First Name (required)

Last Name (required)

Email address (required)

Street Address




Telephone Day

Telephone Eve

How did you find our site?

Are you currently represented by an attorney?

Did you take Zofran/ondansetron during your pregnancy?

Please describe your injury caused by Zofran/ondansetron:

If applicable, please tell us the date of birth of the affected child:

Any additional comments:

Please sign me up for your Consumer Law newsletter. Yes

Sarah London Speaks on Dangerous Zofran Birth Defect Injuries & Lawsuits

Zofran was FDA approved in 1991 to treat nausea from chemotherapy and later expanded for use as a treatment for surgical nausea. Lawsuits allege that the drug has been marketed “off-label” (i.e., promoted in the market for uses not approved by the FDA) by GlaxoSmithKline to obstetricians and gynecologists to prescribe to their pregnant patients to control the pregnancy nausea commonly referred to as “morning sickness.”

Troubling new evidence links Zofran taken during pregnancy with increased risks of certain birth defects including cleft palates, certain heart defects, and other injuries.

Studies on Birth Defect Risks of Anti-Nausea Zofran During Pregnancy

Zofran and Infant Heart Birth Defects

In 2014, the American Journal of Obstetrics and Gynecology published a study highlighting increased risks of serious cardiovascular incidents in pregnant women taking Zofran and discussing conflicting studies that could not rule out similar dangers to the fetus. In addition, in 2013 a Danish study found that in 600,000 pregnancies studied over a seven-year period, where the drug was started earlier than ten weeks into the pregnancy there was a two-fold increase in congenital heart birth defects.

Zofran and Cleft Palate

In January 2012, the Center for Birth Defects Research and Prevention identified a two-fold increased risk for cleft palate associated with exposure to Zofran during pregnancy when taken in the first trimester. There were more than 9,000 pregnant women in the study overall, both cases and controls.

FDA Warning on Use of Zofran During Pregnancy

In July 2014, the FDA issued a safety warning on “serious risks” for mothers associated with taking Zofran, especially in pregnant women with electrolyte imbalance due to severe nausea and vomiting.

In addition, based on recent studies regarding the association between Zofran use in early pregnancy and congenital cardiac malformations and oral clefts (cleft lip and palate), the FDA has strongly cautioned against Zofran’s use in pregnancy.