Zofran Birth Defects
The Ohio dangerous drug lawyers at Clark, Perdue & List are investigating claims related to Zofran birth defects.
Zofran (generic name: ondansetron) is a prescription drug manufactured by GlaxoSmithKline. It was approved for treatment of nausea and vomiting in patients undergoing chemotherapy and surgery, and it has been marketed in the United States since 1991. Although Zofran was never approved by the Food and Drug Administration for use during pregnancy, many physicians prescribed Zofran “off-label” for treatment of morning sickness.
In 2012, GlaxoSmithKline agreed to pay $3 billion to settle U.S. Justice Department allegations that the company illegally promoted Zofran for “off-label” use during pregnancy and that the company disseminated false information regarding Zofran’s safety and paid kickbacks to prescribing physicians.
Several studies have linked Zofran to a greatly increased risk of certain birth defects, including serious heart defects, cleft lip and cleft palate. A Danish study suggested that infants born to woman who used Zofran in the first trimester of pregnancy had double the risk of developing atrial septal or ventricular septal heart defects and a 2.4 fold increase in the risk of developing a cleft palate.
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Taken during early pregnancy, Zofran birth defects include:
Cleft palate – This disorder occurs when the two plates of the skull that form the roof of the mouth are not joined completely, leaving an opening into the nose. In most cases, a cleft lip is also present.
Cleft lip – A cleft lip contains an opening in the upper lip that can extend into the nose. The opening may be in the middle of the lip, on one side of the lip or both sides of the lip. During critical stages of fetal development, tissues of the face do not properly join together. In addition to the cosmetic implications, cleft lips and cleft palates can cause problems with feeding, speech and hearing
Atrial septal defect – This is a heart defect in which blood flows between the upper chambers of the heart (the “atria”). ASD allows oxygen-rich blood to leak into the oxygen-poor heart chambers. It can result in low oxygen level of the blood that supplies the brain, organs and tissues.
Ventricular septal defect – VSD is a hole in the wall separating the lower chambers of the heart (the “septum”). VSD allows blood to flow from the left side of the heart to the right side of the heart, causing oxygen-rich blood to be pumped to the lungs rather than to the rest of the body. VSD can result in higher pressure in the heart and/or reduced oxygen to the body.
Contact the Zofran birth defects attorneys
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