Zofran (common name ondansetron) is a prescription drug developed by GlaxoSmithKline (GSK) to treat symptoms of nausea in cancer patients. Zofran use may cause severe birth defects when taken during pregnancy.
Currently, Zofran has not been recalled despite studies linking the drug’s use during pregnancy to severe birth defects and malformations. However, the drug has been recalled in the past for reasons unrelated to use during pregnancy and links to possible birth defects.
Zofran Recall for Irregular Heart Rhythm
On December 4, 2012, the U.S. Food and Drug Administration (FDA) stated that the 32mg does of Zofran and its generic versions were to be recalled (FDA) because it caused irregular heart rhythms (QT interval prolongation). This irregularity could cause a potentially fatal heart rhythm known as Torsades de Pointes.
Zofran Studies Show Link to Birth Defects
Although no Zofran recalls to date have linked Zofran to birth defects, several studies have linked Zofran use during pregnancy to birth defects and severe developmental abnormalities.
One study found that malformations of the mouth, commonly known as a cleft lip or cleft palate, could be related to Zofran use by mothers while pregnant. These malformations range from visible facial marks to severe developmental issues that can cause difficulty eating or breathing.
The Food and Drug Administration (FDA) has a database for reports of injuries from drug use, called the FDA’s Adverse Event Reporting System (FAERS). Adverse event reports from Zofran use during pregnancy include musculoskeletal anomaly, jaundice, heart murmurs, and other forms of heart defects as side effects of Zofran use during pregnancy.
If you’ve taken Zofran during pregnancy and gave birth to a child with birth defects—cleft lip/palate, heart defects or developmental abnormalities—you may have grounds for a lawsuit.
You can find more information on the birth defects linked to Zofran use here, and complete the contact form on this page for a free case evaluation.
Hissey Kientz is currently taking cases and offering a free case evaluation if you have taken Zofran during pregnancy and your child has suffered birth defects from Zofran use. Please don’t hesitate to contact us using the contact form on this page, by calling toll-free at 1-866-275-4454, or by email at info(at)hkllp(dot)com.
File a Lawsuit
If you’ve taken Zofran during pregnancy and your child was born with birth defects including malformations of the mouth (cleft lip or palate), heart defects, skeletal issues, heart murmurs, jaundice or other similar side effects related to the developmental health of an infant, you may have grounds to file a lawsuit. For information about whether you may have a case, contact the attorneys at Hissey Kientz, LLP by filling out the contact form on this page.