其 他 安 全 警 示
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| The United States: Zofran (ondansetron) - Drug Safety Communication - risk of abnormal heart rhythms (English Only) |
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FDA notified healthcare professionals and patients of an ongoing safety review and labeling changes for the anti-nausea drug Zofran (ondansetron and ondansetron hydrochloride). Ondansetron may increase the risk of developing prolongation of the QT interval of the electrocardiogram, which can lead to an abnormal and potentially fatal heart rhythm, including Torsade de Pointes. Patients at particular risk for developing Torsade de Pointes include those with underlying heart conditions, such as congenital long QT syndrome, those who are predisposed to low levels of potassium and magnesium in the blood, and those taking other medications that lead to QT prolongation. The labels are being revised to include a warning to avoid use in patients with congenital long QT syndrome because these patients are at particular risk for Torsade. Recommendations for ECG monitoring in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or in patients taking other medications that can lead to QT prolongation, are being included in the labels.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm272041.htm
In Hong Kong, a total of 21 ondansetron-containing products are registered and are prescription-only medicines. In view of FDA's action, a letter to inform healthcare professionals will be issued and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Friday, September 16, 2011
Issued at HKT 12:30
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