Drug Linked to Serious Birth Defects When used During Pregnancy

DALLAS (March 9, 2015) – The national law firm of Baron and Budd announced today it is accepting cases from women who used the anti-nausea medication Zofran to treat morning sickness during pregnancy and gave birth to children with serious birth defects, such as heart problems or a cleft palate or cleft lip. A study outlining the potential risks for pregnant women taking the drug was published in the December 2014 issue of the American Journal of Obstetrics and Gynecology.

Zofran is the brand name of the drug Ondansetron and manufactured by GlaxoSmithKline. Zofran prevents nausea and vomiting and is administered through either pills, oral solution or injections. Pregnant women who took the drug during their first trimester of pregnancy have reported serious health issues in their children. These include cleft palate/cleft lip as well as heart problems including atrial septal defects and ventricular septal defects.

Expectant mothers taking Zofran were not warned their children would be at risk for these birth defects. In fact, in many instances, they may have been told Zofran was safe to take to combat morning sickness. According to the study, approximately 110,000 pregnant women received monthly prescriptions for Ondanestron by the end of 2013. This was despite U.S. Food and Drug Administration warnings about the potential for dysrhythmias or abnormal cardiac rhythms in fetuses. The FDA is continuing to evaluate the drug to determine whether there is a need for further regulatory action.

The FDA did not formally approve Zofran for use during pregnancy, meaning any woman who took the drug while pregnant did so “off-label.” While doctors are legally permitted to prescribe drugs for off-label purposes, drug manufacturers and marketers are prohibited from marketing medications for off-label uses. According to information provided by GlaxoSmithKline itself, the drug has not been tested in pregnant women.

“We find it extremely troubling that a drug not specifically approved for use by pregnant women was prescribed to such a large number of expectant mothers throughout the United States,” said Stephen T. Blackburn, an attorney with the pharmaceutical litigation group of the national law firm Baron and Budd.

If you or someone you know took Zofran during pregnancy and gave birth to a child with a health issue such as a heart defect, a cleft palate, or a cleft lip, please contact the national law firm of Baron and Budd to see if you may be eligible to take legal action. Contact us online or call 866-520-2755.

About Baron & Budd, P.C.

The law firm of Baron & Budd, P.C., with offices in Dallas, Baton Rouge, Austin and Los Angeles, is a nationally recognized law firm with a 35-year history of "Protecting What’s Right" for people, communities and businesses harmed by negligence. Baron & Budd’s size and resources enable the firm to take on large and complex cases. The firm represents individuals and government and business entities in areas as diverse as dangerous pharmaceuticals and medical devices, environmental contamination, nursing home abuse, and asbestos-related illnesses such as mesothelioma.