ADR that result in revision of patient information
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| The United States: Ondansetron (Zofran) IV: Drug Safety Communication - QT prolongation |
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The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that preliminary results from a recently completed clinical study suggest that a 32 mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) may affect the electrical activity of the heart (QT interval prolongation), which could pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes. Zofran (ondansetron) is in a class of medications called 5-HT3 receptor antagonists. It is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. GlaxoSmithKline, the manufacturer of Zofran, has announced changes to the Zofran drug label to remove the 32 mg single intravenous dose. The updated label will state that ondansetron can continue to be used in adults and children with chemotherapy-induced nausea and vomiting at the lower intravenous dose recommended in the drug label, a dose of 0.15 mg/kg administered every 4 hours for three doses; however, no single intravenous dose should exceed 16 mg. The new information on QT prolongation does not change any of the recommended oral dosing regimens for ondansetron. As part of the ongoing safety review of ondansetron, FDA continues to assess data about the risk of QT prolongation and will update the public when more information becomes available.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm310219.htm
In Hong Kong, there are 24 registered pharmaceutical products containing ondansetron and are prescription-only medicines. Seven of them are injection products. The safety news on risk of abnormal heart rhythms of ondansetron has been released by FDA and posted on the website of Drug Office on 16 September 2011. A letter to inform healthcare professionals was issued on the same day. The issue was discussed by the Registration Committee (the Committee) of the Pharmacy and Poisons Board on 28 February 2012 and the Committee decided that the drug product label should include safety information on risk of QT prolongation and Torsades de Pointes associated with the drug. In view of the FDA’s updated recommendation, a letter to inform healthcare professionals will be issued and the matter will be further discussed in the meeting of the Committee.
Ends/Tuesday, July 3, 2012
Issued at HKT 12:00
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