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Zofran Birth Defect – Kidney Malformations

Recent research has linked Zofran taken in the first trimester of pregnancy to birth defects, including kidney malformations. Zofran is an anti-nausea drug frequently prescribed to pregnant women for the nausea and vomiting known as morning sickness that typically appears in the first month and lasts through the third or fourth month of pregnancy, according to the National Institutes of Health (NIH). Zofran is prescribed by physicians “off-label,” as it has never been specifically approved for use during pregnancy.

In a study conducted by BioMed Research International, published by the National Center for Biotechnology Information (NCBI) in December 2013, researchers found a 20% increase in the risk of birth defects overall with the use of Zofran in the first trimester of pregnancy. Researchers also found a six-fold increase in the risk of kidney defects, although these findings were based on a small number of cases. In its conclusion, the study states that it could not conclude that ondansetron (Zofran) is safe to use during pregnancy.

If your child has suffered a kidney malformation birth defect and you suspect it was associated with taking Zofran taken during pregnancy, contact Farah & Farah at (800) 533-3555 as soon as possible. Our Zofran birth defect lawyers are currently accepting cases of Zofran-caused birth defects nationwide. We can help you explore your legal options and help you fight for the compensation you will need to cover your child’s medical care and other losses – past, present, and future – suffered by your family.

Significant Amounts of Zofran are Passed to the Fetus

An American Society for Clinical Pharmacology and Therapeutics study published by NCBI found that Zofran passes rapidly through the placenta to the fetus and has a longer elimination half-life for the fetus than it does for the mother. In fact, significant levels of the drug reach the fetus, posing a danger to the forming child.

The FDA issued warnings about the use of this drug for fully-grown adults in 2011 and 2012, and the 32 mg intravenous dosage was recalled in December 2012. Recent research has found increased risk of birth defects, including hole-in-the-heart defects, cleft lip, cleft palate, and kidney malformations with the use of Zofran in early pregnancy.

Case Reports of Zofran Linked to Kidney Birth Defects in Canada

In June 2014, the Toronto Star published an investigative report linking Zofran to a range of birth defects in Canada, including kidney defects. The article states that an analysis of 2012 records revealed more than 20 cases of serious suspected side effects of ondansetron taken during pregnancy, including two infant deaths and multiple newborns with heart defects and kidney malformations.

Kidney Malformation Birth Defects

The Merck Manual reports that birth defects occur more frequently in the kidneys and the urinary tract than in any other body system. A defect can slow or block the flow of urine, which can result in infections or painful kidney stones. It can also result in increased urine pressure, causing the urine to flow backwards from the bladder to the kidneys, damaging the kidneys and other parts of the urinary tract.

Abnormal kidney birth defects can appear in various forms. The kidneys may be:

  • In the wrong location (ectopia)
  • Positioned wrong (malrotation)
  • Joined together (horseshoe kidney)
  • One missing (agenesis)
  • Developed abnormally (polycystic kidney disease, for example)
  • Missing entirely (Potter’s syndrome), which causes death

Some birth defects involving malformation of the kidneys are not detected, as no symptoms are evident. Other kidney birth defects can interfere with kidney function, leading to kidney failure and the need for dialysis, or kidney transplant surgery. Birth defects that cause symptoms or increase the pressure on the kidneys generally need to be corrected with surgery.

Legal Help for Zofran Kidney Malformation Birth Defects

If you took Zofran on the advice of your physician during pregnancy and your child was born with a serious kidney malformation birth defect, your best course of action is to consult with a knowledgeable product liability attorney. At Farah & Farah, our practice is devoted to representing people who have been injured by dangerous drugs and devices.

Contact our office for a free case consultation to find out about your options under the law, and how our firm can help you. We are investigating Zofran birth defect cases nationwide, and you can have confidence that our tenacious Zofran attorneys will fight for the full and fair compensation your family is entitled to receive.


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The pharmaceutical litigation attorneys at Farah & Farah go after negligent corporations that put unsuspecting consumers in harm's way. Pharmaceutical companies not only have a duty to manufacture drugs that are safe, but they also have the obligation to warn consumers regarding dangerous side effects that can be caused by these drugs.

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