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FDA Warns: Abnormal Heart Rhythms May Be Associated with Use of Zofran (Ondansetron)
The U.S. Food and Drug Administration (FDA) is conducting an ongoing safety review of the anti-nausea drug Zofran (ondansetron) and its generics. Ondansetron may increase the risk of developing abnormal changes in the electrical activity of the heart called QT prolongation. This abnormal change in the electrical activity of the heart can result in a serious and potentially fatal abnormal heart rhythm.
The FDA has reviewed all available information to date and is making changes to the prescribing information of Zofran and its generics to include a warning to healthcare providers to avoid use of this medicine in patients with the heart condition called congenital long QT syndrome because these patients are at particular risk for abnormal hearth rhythms. Additionally, healthcare providers have been advised to monitor heart rates and rhythms by regularly performing an electrocardiogram (ECG, EKG) in patients taking Zofran or ondansetran who are at higher risk due to: having electrolyte abnormalities (such as low potassium or low magnesium levels in the blood called hypokalemia), having congestive heart failure (CHF), having a slow heart rate, or taking other medications that can lead to abnormal changes in the electrical activity of the heart.
As part of the review, the manufacturer of Zofran (GlaxoSmithKline) is required to conduct a study to assess the potential for the drug to cause abnormal changes in the electrical activity of the heart. The FDA will update the public as new information becomes available from this study.
Zofran (ondansetron) and its generics are used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery.
For more information, please visit:
http://www.fda.gov/Drugs/DrugSafety/ucm271913.htm
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Pure Encapsulations, Incorporated Recalls Prenatal Nutrients Products
Pure Encapsulations, Incorporated has recalled their prenatal product PreNatal Nutrients. The recall was made because the product may contain egg, an undeclared allergen. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume these products. The recall includes PreNatal Nutrients 60-count bottles and 120-count bottles. The recalled lot numbers are 3560111B or 3560111 A with a ‘best by’ date of January 2013.
PreNatal Nutrients was distributed nationwide through healthcare providers.
For more information, please visit:
http://www.fda.gov/Safety/Recalls/ucm270430.htm
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