September 15, 2011 — The FDA issued a Drug Safety Communication alerting the medical community to the risk of abnormal heart rhythm associated with the anti-nausea medication Zofran (generic: ondansetron or ondansetron hydrochoride). In some cases, the abnormal heart rhythm can become severe, leading to conditions such as Torsade de Pointes, which may be lethal. Patients with predisposed conditions that place them at higher risk of an irregular heart rhythm are being advised to avoid the drug.

What You Can Do & How We Can Help

The Schmidt Firm, LLP is currently accepting Zofran induced injury cases in all 50 states. If you or somebody you know has been injured by Zofran, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Dangerous Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Zofran: An Overview

Zofran was initially approved by the FDA in December 1992 as an oral medication taken to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. Manufactured by GlaxoSmithKline, it belongs to a class of drugs known as 5HT3 receptor antagonists. These work by blocking the action of serotonin, a natural substance in the body that is known to trigger nausea and vomiting.

Recently, however, the FDA announced Zofran is the subject of an ongoing safety review, prompting a change to the product’s label. The FDA states that the anti-nausea drug Zofran may increase the risk of developing abnormal changes in the electricity of the heart, which can result in abnormal and potentially fatal heart rhythms, including Torsade de Pointes.

Those most at risk of developing irregular heart rhythms include patients with underlying heart conditions (like congenital long QT syndrome), those with low levels of potassium and magnesium in the blood, and those taking other medications linked to QT prolongation.

Due to the severity of these risks, patients who have taken Zofran and developed abnormal heart rhythms may want to contact a Zofran lawyer or attorney with The Schmidt Firm, LLP to discuss the possibility of a Zofran lawsuit.

What is Torsade de Pointes?

Changes in the electrical activity of the heart (known as the prolongation of the QT interval, or how long it takes for the heart muscles to contract and recover), may lead to abnormal heart rhythms, which include Torsade de Pointes.

Torsade de Pointes is a potentially fatal abnormal heart rhythm that means “twisting of the points” in French. It describes a rare, but lethal form of ventricular tachycardia — or an irregularly fast heart rhythm. The heart is beating so quickly that it appears as if the waves of an electrocardiogram (ECG or EKG) are twisting. Torsade de Pointes is deadly because it causes less blood to pump to the brain, causing fainting. It can occur without warning and can only be detected through an EKG, making it difficult to treat.

If untreated, episodes of Torsade de Pointes can change from lasting a minute to lasting longer. If this occurs, it leads to ventricular fibrillation — where the heart beats so fast it stops functioning all together. Without medical intervention, like a defibrillation, it can lead to permanent brain damage or death.

Zofran Side Effects

Because most irregular heart rhythms do not cause any symptoms, most doctors can only detect them through an exam or through an electrocardiogram (ECG, EKG). However, some of the warning signs of a possible irregular heart rhythm include:

• Palpitations (feeling of a fluttering heart beat)
• Pounding in your chest
• Dizziness
• Light-headedness
• Fainting
• Shortness of breath
• Chest discomfort
• Weakness or fatigue

Besides the risk of abnormal heart rhythms, Zofran may cause other side effects including:

• Allergic reaction (rash, hives, itching, difficulty breathing, swelling)
• Blurred vision
• Temporary vision loss
• Slow heart rate
• Trouble breathing
• Anxiety, agitation
• Shivering
• Feeling like you might pass out
• Urinating less than usual or not at all

Less serious side effects include:

• Diarrhea
• Constipation
• Weakness
• Fatigue
• Fever
• Headache
• Dizziness
• Drowsiness

FDA Warning and Label Change

In a September 15, 2011 Safety Communication, the U.S. Food and Drug Administration advised the public that it was reviewing Zofran’s safety after medical literature described risks of changes in electrical heart activity. The FDA is also asking Zofran manufacturer GlaxoSmithKline to thoroughly study the potential for the drug to prolong QT intervals. The study’s results should be available in the summer of 2012.

While warnings about possible EKG interval changes (or QT interval prolongation) were already included in the drug label, the drug labels on Zofran products are being revised to include additional information. A new warning will be included, which encourages patients with congenital long QT syndrome (who are at a higher risk of developing Torsade) to avoid Zofran use. Additionally, the FDA is recommending EKG monitoring for patients with:

• Hypokalemia or hypomagnesemia (magnesium or potassium electrolyte abnormalities)
• Congestive heart failure
• Bradyarrhythmias
• Patients taking other medications that can cause QT prolongation

While the FDA waits for the results from the manufacturer study for more information, it offers these recommendations:

• ECG changes including QT interval prolongation have been seen in patients receiving Zofran. In addition, Torsade de Pointes, an abnormal heart rhythm, has been reported in some patients receiving ondansetron.
• The use of Zofran should be avoided in patients with congenital long QT syndrome.
• ECG monitoring is recommended in patients with electrolyte abnormalities such as hypokalemia or hypomagnesemia, congestive heart failure, bradyarrhythmias, or patients taking concomitant medications that prolong the QT interval.
• Patients should be advised to contact a healthcare professional immediately if they experience signs and symptoms of an abnormal heart rate or rhythm while taking Zofran.

Do I Have a Zofran Lawsuit?

The Schmidt Firm, LLP is currently accepting Zofran induced injury cases in all 50 states. If you or somebody you know has been injured by Zofran, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Dangerous Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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