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Zofran Caused Heart Defects, Facial Abnormalities

Aug 8, 2016

A recently filed lawsuit alleges that Zofran, an anti-nausea medication manufactured by GlaxoSmithKline (GSK), is to blame for a child's congenital abnormalities, including two cardiac defects and facial dysmorphia. The suit was filed on behalf of a woman who says that she was prescribed Zofran to treat morning sickness and migraines during her first trimester of pregnancy. In May 2007, her daughter was born with atrial and ventricular septal defects. These “hole in the heart” defects occur when there is a hole in the septum, the muscular wall separating the left and right sides of the heart; this prevents blood from being shunted properly throughout the heart and may lead to a host of problems.

According to the lawsuit, the child had a low birth weight when born and continues to suffer developmental delays. She requires specialized education services, her mother says. Additionally, she also alleges that the child has hydronephrosis, or swelling of the kidneys. The lawsuit states that the child was born with numerous facial abnormalities, including a high palate, recessed chin, small jaw and clinodactyly, a condition in which the pinky fingers bend inward from the topmost knuckle.

The lawsuit alleges that these defects are a result of the mother taking Zofran during pregnancy. The lawsuit also alleges that genetic testing had been performed, and no genetic anomalies had been identified. Studies have suggested that Zofran may lead to septal defects when used during pregnancy. In 2013, researchers in Denmark published a study showing that cardiac septal defects are two to four times as likely to occur in children exposed to Zofran in utero compared to those who are not.

The U.S. Food and Drug Administration (FDA) has approved ondansetron, Zofran's main active ingredient, to treat nausea caused by chemotherapy, radiation therapy, and anesthesia associated with surgery. The drug is not approved to treat morning sickness. The lawsuit alleges that GSK illegally promoted Zofran for off-label use in pregnant women, placing these women’s children at risk for birth defects. The case was transferred to Boston court, alongside more then 270 similar lawsuits.

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