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FDA Reports Indicate Ondansetron Linked to Birth Defects

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Los Angeles, CA: Ondansetron, an antinausea drug used in patients receiving chemotherapy is reportedly causing birth defects in babies born to women who are prescribed the drug for morning sickness. A report in the Canadian newspaper, The Toronto Star in June 2014, stated that ondansetron is being prescribed by doctors for the extreme type of morning sickness called Hyperemesis gravidarum.

For their investigation, The Star looked at Canadian side-effect reports filed with the US Food and Drug Administration' (FDA) database between 2010 and 2013 and found that at least 20 pregnant Canadian women treated with ondansetron experienced side effects, including two infant deaths and several cases of babies born with kidney and heart defects.

Other defects listed, which were all based on physician opinion, included a musculoskeletal anomaly and a mouth deformity, jaundice, heart murmur and two heart defects, including "atrial septal defect,"otherwise known as a hole in the heart.

Four of the babies featured in the FDA side-effect reports the Star reviewed were born weighing as little as four-and-a-half pounds. In six cases, a suspected side-effect of ondansetron was listed as "fetal growth restriction."

Ondansetron is approved for use in chemotherapy patients for the treatment of nausea but it is not approved in Canada for the treatment of nausea related to morning sickness, which means it is being prescribed " off-label". GlaxoSmithKline makes a brand-name version called Zofran and generic versions are made by several other companies.

The use of ondansetron in pregnant women is controversial and the results of several studies looking at its use in this population have produced conflicting results. However, scientists from Toronto to Denmark agree more research is needed.

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Posted by
jordan candelera
My son was born with a VSD that her doctors are extremely concerned about. My son has to regularly visit the pediatric cardiologist. It may grow back. Mayis nice word, for saying you dont know doc

Posted by
My daughter was born with a heart murmur that her doctors are extremely concerned about. My daughter has to regularly visit her pediatric cardiologist. My daughter also was born with a muscular/skeletal defect in the thumb. The doctors are concerned and don't understand what it is or where it came from.


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