Heart Defects And Zofran Use During Pregnancy

Are you looking for answers to why your child was born with a birth defect? If your baby has a hole in the heart and you took Zofran while pregnant, you may have a case against the drug's manufacturer GlaxoSmithKline.

Zofran/ondansetron was not approved for use in pregnant women by the U.S. Food and Drug Administration (FDA), but it was marketed off-label to treat nausea and vomiting. The experienced attorneys at Kelley & Ferraro, LLP, are now investigating cases of heart defects that may have been the result of taking Zofran during pregnancy. Let us help you find answers and seek compensation.

Studies Show That Zofran Presents Danger To Developing Fetuses

Several studies in recent years have found that Zofran can cause harm to babies when it is taken in the first trimester of pregnancy. A 2013 Danish study reported that the risk for heart defects doubled when mothers took ondansetron during the first 10 weeks of pregnancy. A study conducted by public health officials in Sweden and published in December 2014 also concluded that fetuses exposed to ondansetron during the first trimester were more likely to be born with heart defects.

Babies born to women who took these drugs in the first trimester may have defects that are sometimes referred to as holes in the heart:

  • Atrial septal defects
  • Ventricular septal defects
  • Atrioventricular septal defects

In these types of heart defects, the cardiac tissue does not develop correctly, causing the child to have holes between the heart's chambers. While small holes may close on their own, larger ones typically require surgery to repair the hole. Depending on the severity of the heart defect, the child may need considerable ongoing medical care after the surgery.

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