What are the Side Effects Of Zofran?

Zofran (Ondansetron) is a medication that is commonly prescribed for the treatment of nausea and vomiting that occurs after surgery, or due to chemotherapy. This is drug is also used “off label” for the treatment of morning sickness. Unfortunately is has been found that this drug used while pregnant may cause heart murmurs, cleft lip or palate, atrial septal defects, ventricular septal defects, heart defects and fetal death. If you have taken Zofran during pregnancy and your child has been diagnosed with a birth defect, it is important to take prompt action. You could be entitled to compensation for your injuries which may include reimbursement for medical expenses, pain and suffering and loss of income. Contact the Bradley Law Firm for guidance and a free consultation.

This drug is known as a 5-HT3 receptor antagonist. It works by encouraging gastric emptying and blocking serotonin. This combined action reduces the incidence of nausea and vomiting in patients. This drug is manufactured by GlaxoSmithKline and has been illegally marketed for “off label” use by pregnant women for preventing morning sickness. It appears that GlaxoSmithKline has been illegally marketing the drug to pregnant women and intentionally withholding information.

Zofran and Birth Defects

Zofran is classified as a “pregnancy category B” drug, which means that it showed no risk to pregnant women. This classification flies in the face of several studies that suggest otherwise. In 2012, there was a large study that found a link between the drug and the presence of cleft palates in children whose mothers took Zofran. It stated that women taking the drug were 2.3 times more likely to have a child with a cleft palate.

A cleft palate is a defect where the baby’s mouth does not close during development. This defect may also include a cleft lip. Unfortunately, babies with this defect often experience:

  • Dental problems
  • Hearing issues
  • Speech delays
  • Chronic malnutrition.

In earlier studies, it was suggested that Zofran use by pregnant women caused heart problems in infants that included:

  • Heart murmurs: extra sounds and heart beats
  • Ventricular defects: Involves a hole in the wall of the lower chamber of the heart which causes blood to get pumped into the lungs
  • Atrial septal defects: A hold in the wall of the heart between the upper chambers.

According to the FDA, there are a growing number of women who have reported numerous adverse side effects from taking the drug. This included claims of rashes, shortness of breath, fainting, dizziness and irregular heartbeat. In addition, there was one reported infant death, and four reports of infants being born with “fetal growth restriction.”

Zofran Lawsuits

Because GlaxoSmithKline failed to warn consumers that this drug was unsafe for pregnant women, lawsuits are being filed across the country. These cases contend that the manufacturer knew or should have known that Zofran was not safe. The company appears to have put their financial well-being over that of the consumer by encouraging the use of the product.

Lawsuits against the company are stacking up, as every day more women come forward reporting birth defects in their children after taking Zofran. These lawsuits claim:

  • GlaxoSmithKline had a duty to ensure that the drug was safe for the consumer.
  • The company failed to warn the public of the dangers of taking this drug.
  • The company advertised that the drug was safe to use “off label.”
  • Misrepresented animal studies that reported that Zofran caused toxicity and abnormal bone growth.

In 2012, the company agreed to pay 3 billion dollars as a settlement for off label marketing and withholding safety data. The U.S. Department of Justice called the settlement “the largest health care settlement in history.”

While the settlement included other drugs and offenses, it ordered that 2.3 million dollars be paid by GlaxoSmithKline to the U.S. Government for fraudulently marketing Zofran. Another $56 million was to be paid for the kickbacks they were paying physicians to encourage the use of the drug off label.

Contact Us

E. Ryan Bradley understands that if you have experienced complications from taking Zofran, you are likely confused about where to go from here. Contact Mr. Bradley for a free case evaluation. You can have your questions answered and learn what legal options may be available to you. Contact the firm at 314-400-4000.

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