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Zofran Birth Defects: Issues

By Andrew Sullo

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The drug Zofran (Ondansetron), approved by the FDA to prevent the nausea and vomiting caused by cancer chemotherapy, radiation and surgery, has been widely prescribed off-label to help pregnant women suffering from severe nausea. Zofran is in a class of medications known as 5-HT3 receptor antagonists. The drug works by blocking serotonin, a natural substance in the body which may cause nausea and vomiting. Unfortunately, this off-label usage may be responsible for Zofran birth defects. Some of those birth defects potentially related to Zofran include:

• Renal problems and defects;

• According to some studies, double the risk of heart defect;

• Two and a half times the risk of cleft lip and cleft palate;

• Poor fetal growth;

• Defects of the musculoskeletal system, and

• Fetal death.

As more birth defects are being tied to Zofran, Zofran birth defects lawsuits are increasing. Many of these lawsuits allege the manufacturer of the drug illegally marketing Zofran for morning sickness and failed to warn the medical community about the potential risks of using the drug during pregnancy.


When Zofran Received FDA Approval

Zofran received FDA approval in April, 1998 for postoperative vomiting and nausea in adults via intramuscular administration. The IV and tablet form of Zofran had already been approved by the FDA in 1991, however the intramuscular form allowed those with small veins or those who had trouble swallowing pills to receive the drug.  At the time of approval, the negative side effects noted in postoperative clinical tests included dizziness, headache, drowsiness, sedation and constipation as well as skin rashes in some patients. Unfortunately, there were much more serious side effects which would later be tied to Zofran, particularly Zofran birth defects.


The Manufacturer of Zofran and the FDA

GlaxoSmithKline took some major heat for Zofran in 2011 when a Zofran FDA warning linked- the drug to potentially fatal cardiac arrhythmia. The FDA announced it would be conducting ongoing safety reviews of Zofran, and ordered GlaxoSmithKline to conduct its own internal investigation as well.  It was found that Zofran could potentially interfere with the electrical activity of the heart by prolonging a specific point in the heart’s normal rhythm known as the “QT Interval.”

In 2012, GSK faced allegations from the U.S. Justice Department over the off-label promotion of Zofran and other drugs. The manufacturer agreed to pay $3 billion to resolve the criminal and civil charges; at that time the Department of Justice noted the Zofran case resolution was the largest health care fraud settlement in United States history.

In November, 2013, the FDA issued an updated warning for Zofran, specifically related to the use of the drug to treat severe morning sickness. The FDA cited certain studies regarding the potential association between Zofran and congenital cardiac malformations as well as cleft lip and palate in babies whose mothers took Zofran. The FDA also cited potential maternal risks including electrolyte imbalances and the Seratonin Syndrome.


Zofran Birth Defects Lawsuits

While the DOJ may have received “justice” the babies and mothers harmed by Zofran birth defects have not. The many Zofran dangers associated with birth defects were not communicated to mothers who took the drug on the advice of their physician to ease severe nausea. Mothers whose babies suffered Zofran birth defects may want to consider obtaining Zofran legal help in order to determine the strength of their case against GSK. According to a June 2014 Toronto Star Article that analyzed public side-effect report data from the FDA, at least 20 pregnant Canadian women treated with Zofran experienced serious Zofran side effects including two infant deaths and multiple babies who suffered from heart and kidney defects.


Getting Zofran Legal Help from a Zofran Birth Defect(s) Lawyer

If you believe you could benefit from the advice of an experienced Zofran Birth Defect(s) Lawyer, the Zofran Birth Defects Attorneys of Sullo & Sullo would like to hear from you. We understand that you may be confused and are uncertain of what you should do. A knowledgeable and experienced Zofran Birth Defects Lawyer should be capable of providing you sound and reasonable advice on your potential case. To get legal help, consider contacting a Zofran Birth Defects Lawyer today.

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