Zofran Linked to Birth Defects
Zofran causes cleft palate and cardiac malformations in infants
Zofran (ondansetron) is a member of a class of medications known as 5-HT3 receptor antagonists. Zofran works by reducing the effects of seratonin in the body, which is known to cause nausea and ultimately vomiting. Zofran was approved by the FDA more than 20 years ago for the treatment of nausea in chemotherapy and surgery patients. It soon became popular to prescribe Zofran to pregnant women to combat morning sickness during pregnancy. It is not approved for use in pregnant women but has gained an increasingly widespread market share as an “off label” prescription for expectant mothers.
In 2013, researchers from Denmark presented a study that followed nearly 900,000 pregnant women between 1997 to 2010. The study revealed a 2-fold increased risk of cardiac malformations while taking Zofran, leading to an overall increased risk of major malformations of 30%.
In 2006, a study in Hong Kong found that Zofran has the ability to cross the human placenta in the first trimester of pregnancy. The researchers detected Zofran in every sample of fetal tissue taken among 41 patients.
Recently, a large study of over 9,000 pregnant women undertaken by the Slone Epidemiology Center and the National Center on Birth Defects and Developemental Disabilities detected a 2-fold increased risk for cleft palate associated with Zofran (ondansetron) taken for nausea and vomiting in pregnancy in the first trimester of pregnancy.
A 2014 Danish study conducted in part by the National Board of Health and Welfare found that the use of Zofran (ondansetron) during pregnancy significantly increased the risks for cardiovascular malformations in infants—most notably defects in the cardiac septum. An Australian paper published in late 2013 noted a 20% increased risk of a major birth defect among children exposed to Zofran (ondansetron) in the first trimester.
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If you or a loved one took Zofran while pregnant and had a child born with cleft palate or cardiac malformations, contact the Zofran class action lawsuit attorneys of Aylstock, Witkin, Kreis & Overholtz at (844) 794-7402.
More information can be found at the National Institutes of Health: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3299087/