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St. Louis ZOFRAN® Side Effects Injury Lawyers


Zofran® (ondansetron) is approved to treat nausea and vomiting in chemotherapy and surgery patients. The FDA has not approved Zofran® for pregnant women, but some doctors prescribe it “off-label” to treat severe morning sickness.

Zofran® was developed by GlaxoSmithKline (GSK) and approved in the United States in 1991. The first generic versions were approved in 2006.

How Does Zofran® Work?
Zofran® is a 5-HT3 antagonist that primarily acts on the nervous system. It works by blocking serotonin and increases gastric emptying, which helps reduce nausea and vomiting. It basically interrupts the messages sent from the brain to the rest of the body that it should feel nauseous and get ready to vomit.

Off label use: Recently GlaxoSmithKline found a new market for this drug, women who were pregnant, and saw a potential new revenue stream that could generate millions of dollars in revenue for GlaxoSmithKline.

Morning Sickness
Nausea and vomiting are estimated to affect 70-85% of pregnant women during the first trimester (weeks 6-12 of pregnancy), but hypermesis gravidarum, or extreme morning sickness, only affects about 1% of all pregnancies.

The condition is defined as uncontrolled vomiting requiring hospitalization, severe dehydration, nutritional deficiencies, muscle wasting, electrolyte imbalance, and weight loss of more than 5% of body weight — all of which pose serious health risks to both the mother and fetus.

What are the known Zofran® Birth Defects in Newborns?
Though it is uncertain of the timing and dosage use for mothers taking Zofran®, one thing is clear. There is a distinct possibility of newborns being born with:

  • cleft palates
  • cleft lip
  • three types of heart defects including:
    • ASD – (Atrial Septal Defect)
    • VSD – (Ventricular Septal Defect)
    • Heart Murmur
    • Studies Explore Zofran® Pregnancy Issues

The potential link between Zofran® and birth defects has been explored in a number of studies conducted in the U.S. and abroad. In August 2013, researchers reported a two-fold increase in cardiovascular defects born to children whose mothers took Zofran® during their first trimester of pregnancy. The research was published in Montreal at a meeting of the International Society of Pharmacoepidemiology, and revealed that 4.7 percent of individuals who took the drug at the beginning stage of their pregnancy bore children with congenital abnormalities, as opposed to 3.5 percent who did not taken the medication.

Overall, the study’s authors concluded that women taking Zofran®, or ondansetron, were 30 percent more likely to have a child with birth defects.
The study looked at 900,000 pregnant women over a 13-year period, and analyzed data from a patient registry in Denmark.

That previous February, research published in The New England Journal of Medicine found little association between Zofran® and the risk for birth defects, but it should be noted that it looked at fewer patients (2,000), over a shorter period of time (seven years).

GlaxoSmithKline Resolves Civil Liability for Allegedly Promoting Zofran® for Off-Label Uses
GlaxoSmithKline has faced claims by the United States accusing the company of promoting various medications, including Zofran®, for off-label uses (i.e., uses other than the condition for which it was approved by the FDA). In 2012, these claims were resolved in a civil settlement, though the company denies the allegations made against it. Pregnant women who took Zofran® and who delivered children with birth defects were not compensated through the company’s settlement with the government.  

We believe that if you or someone you love have suffered from an injury resulting from the use of Zofran® you should be fairly compensated for your damages. Damages can include:

  • Medical Bills
  • Permanent Injuries
  • Emotional Suffering
  • Loss in the Quality of Life
  • Potential Risk of Future Medical Complications
  • Increased Health Insurance Costs
  • Lost Wages

The Roberts Law Firm, P. C. would like to assist you in pursuing compensation for your injury or the injury of a loved one. We are currently evaluating claims who may have suffered injury. We are representing injured parties on a contingent fee basis which means that there are no legal fees owed unless you are awarded compensation for your injury. For a free, no obligation case review please call 866-585-3690 toll free or fill out our online contact form and we will contact you to answer any of your questions. If you or a loved one has been injured after taking the drug Zofran®, The Roberts Law Firm, P.C. may be able to help.

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