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Zofran FAQs

Frequently Asked Questions

Our knowledgeable pharmaceutical litigation lawyers at Farah & Farah are investigating cases nationwide for individuals and families who have suffered harm from the use of Zofran. The drug was manufactured and marketed by pharmaceutical giant GlaxoSmithKline. We have devoted our practice to representing people injured by dangerous drugs and devices, and you can have confidence in the diligent representation we provide. Here we have answered some frequently asked questions about Zofran.

 

What kind of drug is Zofran?

Is Zofran safe to use during pregnancy?

Why do doctors prescribe Zofran to pregnant women when it hasn’t been FDA approved for use during pregnancy?

What birth defects are linked to Zofran?

Can Zofran cause heart problems?

What are the symptoms of heart rhythm issues caused by Zofran?

What action has the government taken against the drug company that makes Zofran?

How can a pharmaceutical litigation lawyer help someone who has been harmed by Zofran?

 


 

What kind of drug is Zofran?

A: Ondansetron (Zofran) is an anti-nausea drug for patients who are undergoing chemotherapy or radiation treatment for cancer and to prevent nausea after surgery, FDA approved for those purposes — with warnings. It works by partially blocking serotonin, a brain chemical needed for the nausea response and many other functions of the body. Zofran has not been approved for use during pregnancy, but many doctors have prescribed it “off-label” for pregnant women suffering from severe morning sickness.

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Is Zofran safe to use during pregnancy?

A: Although some physicians have prescribed it off-label, Zofran was never FDA approved as a drug safe for use during pregnancy. Recent research has revealed that the drug is not safe for use by pregnant women. The FDA cautioned against the use of Zofran for patients with electrolyte abnormalities, and many women have electrolyte imbalances during the term of a pregnancy. Even more alarming are the recent studies that have linked the use of Zofran in the first trimester of pregnancy to a number of serious birth defects.

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Why do doctors prescribe Zofran to pregnant women when it hasn’t been FDA approved for use during pregnancy?

A: Doctors prescribe a number of medications to pregnant women that have not been FDA approved for use during pregnancy. Severe morning sickness can cause weight loss and dehydration and interfere with the baby’s development. Until doxylamine and pyridoxine received FDA approval specifically for nausea and vomiting during pregnancy in April 2013, there was no anti-nausea, FDA approved drug for use during pregnancy available to American women, an issue that continued for three decades. A lawsuit brought by the government against Zofran’s manufacturer alleged that the company improperly promoted the drug for off-label (not approved by the FDA) use.

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What birth defects are linked to Zofran?

A: Researchers in recent studies have found increased risk of birth defects for infants whose mothers took Zofran in early pregnancy. Birth defects linked to Zofran include: craniofacial defects (cleft palate and cleft lip); heart defects (holes in the walls between the chambers or in the center of heart); and kidney malformation defects.

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Can Zofran cause heart problems?

A: Yes. The FDA issued a warning about Zofran in September 2011 and updated its information in June 2012 because of heart rhythm issues linked to the use of this drug. The FDA warned physicians and patients that ondansetron (Zofran) may affect the heart’s electrical activity (QT interval prolongation) and cause the patient to be predisposed to abnormal and potentially fatal heart rhythms, a condition known as “Torsades de Pointes.” Following its safety warnings, the FDA announced a recall of the 32 mg single intravenous dosage of Zofran in December 2012.

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What are the symptoms of heart rhythm issues caused by Zofran?

A: In its first safety warning issued in September 2011, the FDA warned patients using Zofran that their doctors may order electrocardiograms to monitor their heart rhythms and heart rate. It advised them to seek immediate medical attention if they experienced any of the following symptoms:

  • Irregular heartbeat
  • Shortness of breath
  • Fainting
  • Dizziness

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What action has the government taken against the drug company that makes Zofran?

A: The U.S. Department of Justice announced in a July 2012 press release that Zofran manufacturer, GlaxoSmithKline (GSK), agreed to plead guilty to criminal charges and pay $3 billion to resolve its civil and criminal liability resulting from GSK’s unlawful promotion of prescription drugs, failure to report safety data to the FDA, and alleged false price reporting. This is the largest payment ever made by a drug company and the largest settlement for health care fraud in U.S. history.

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How can a pharmaceutical litigation lawyer help someone who has been harmed by Zofran?

A: Drug manufacturers have a responsibility to ensure their products are safe to use. At Farah & Farah, we believe in holding big pharmaceutical companies accountable for the harm caused by dangerous drugs. Our Zofran injury attorneys have the knowledge, skills, and dedication to help you pursue the compensation you deserve for all damages, both economic and non-economic. Contact us at (800) 533-3555 for a free case consultation.

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Who We Are

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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