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FDA Announces Zofran Recall Due To Potential Cardiac Risks

By Burg Simpson
December 5, 2012
2 min read

Potential for Serious Cardiac Risks with Zofran (ondansetron) Leads to Removal of 32mg, Single Intravenous (IV) Dose from Market.

On December 4, 2012, the FDA announced that Zofran (ondansetron), commonly used to prevent nausea and vomiting caused by chemotherapy, will no longer be marketed in a 32mg, single intravenous (IV) dose, due to potentially fatal cardiac risks.

FDA Announcement

The FDA’s announcement comes after more than a year of investigation into Zofran’s association with abnormal changes in the heart’s electrical activity.  In September 2011, following two published studies and known cardiovascular safety concerns, the FDA announced that Zofran “may increase the risk of developing abnormal changes in the electrical activity of the heart, which can result in a potentially fatal abnormal heart rhythm.”  The FDA, further revised ondansetron labeling and required the manufacturer of Zofran (GlaxoSmithKline) to thoroughly study the effects of its drug on the electrical activity of the heart.

September Safety Announcement

The results of GlaxoSmithKline’s study showed the potential for the prolongation of the QT interval of the electrocardiogram (ECG) associated with the 32mg, single IV dose of Zofran.  This condition can lead to an abnormal and potentially fatal heart rhythm, including Torsade de Pointes.

These findings have led the FDA to work with the brand and generic manufacturers of the 32mg, single IV dose to recall the product from the market completely.

FDA urges patients taking Zofran to seek immediate care if they experience an irregular heartbeat, shortness of breath, dizziness, or fainting.

If you or a loved one has been injured or died as a result of an abnormal heart rhythm following the use of Zofran (onsdansetron) you may be entitled to compensation.  Burg Simpson has a national reputation as being a leader for plaintiffs and victims in personal injury litigation against pharmaceutical manufacturers.  We would be happy to review your records to determine if you have a viable case. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.

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