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Zofran Use May Be Linked to Birth Defects

April 30, 2015  ·  By HM&M

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Parents want their infants and children to be healthy and thrive. It can be a devastating blow when they find out their child may or will have a life-long condition that may be life-threatening. Congenital heart defects are heart problems that develop before the child is born and are often referred to as a hole in the heart. Congenital heart defects can lead to heart failure, high blood pressure, infection, or other problems from the moment they are born or later on in life. In some cases, the congenital heart defect is caused by defective drugs, such as Zofran.

Zofran is manufactured by GlaxoSmithKline and has been approved by the Federal Drug Administration (FDA) for use as an anti-nausea medication for cancer patients going through chemotherapy. It has not been approved, or ever tested or studied, as an anti-nausea drug for pregnant women. This has not stopped GlaxoSmithKline from marketing Zofran for “off-label” use to hospitals and consumers as an anti-nausea medication for pregnant women with severe morning sickness, according to a report from the Department of Justice.

A mother from Oakland, California, filed a lawsuit against GlaxoSmithKline, stating they knew about the negative side effects Zofran caused during the prenatal stages of growth in infants and still marketed the drug to pregnant women. She alleged that the use of Zofran during her pregnancy caused her son’s supraventricular tachycardia, a serious heart defect. Supraventricular tachycardia (SVT) causes the heart to beat too fast or irregularly. It causes an insufficient about of blood supply throughout the body. SVT is treated with medication, surgery, or a combination of both and in the future may cause heart failure.

GlaxoSmithKline received reports of defects and continued to falsely advertise Zofran as safe and effective for use in pregnant women. They should not have advertised Zofran for an “off-label” use in pregnant women after receiving these reports. They should have gone through the proper clinical trials and approval process through the FDA to make sure it had no negative side effects. Many families will now have life-changing conditions in their children due to heart defects. Some of these children may not survive. No family should have to go through the worry and heartache of losing a child due to a defective drug.

Using drugs for “off-label” uses is not acceptable. It can lead to devastating effects on those taking the drugs, as well as unborn children if pregnant, if used without being tested for side effects first. Contact an attorney today if you or a family member has a heart defect caused by Zofran or was prescribed Zofran while you were pregnant.

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