Other safety alerts
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| Canada: Zofran (ondansetron) - Association with Changes in Electrical Activity in the Heart |
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GlaxoSmithKline Inc., in collaboration with Health Canada, would like to notify the public and healthcare professionals of new information regarding the risk of electrocardiographic QT interval prolongation associated with Zofran (ondansetron). Zofran is indicated in adults of all ages for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting and in adult ≤65 years of age for the prevention and treatment of post-operative nausea and vomiting. Zofran is also indicated in children 4 years of age and older for the prevention of chemotherapy-induced nausea and vomiting.
A recently completed study identified a dose-dependent prolongation of the corrected QT interval (QTc) among healthy subjects treated with ondansetron. QTc interval prolongation can lead to Torsade de Pointes (TdP), a potentially life-threatening heart rhythm abnormality. Findings and recommendations based on this new study are as follows:
1. Ondansetron can cause a dose-dependent prolongation of the electrocardiographic-corrected QT interval (QTc), which can lead to Torsade de Pointes, a potentially life-threatening heart rhythm abnormality.
2. The new maximum recommended single intravenous (IV) dose of Zofran is 16 mg infused over 15 minutes.
3. The 32 mg IV dose of Zofran and the 8 mg intravenous dose followed by a 1 mg/hour continuous infusion of Zofran are no longer recommended and should not be used.
4. Avoid ondansetron in patients with congenital long QT syndrome. Use caution if administering ondansetron to patients with other risk factors for QT interval prol ongation, such as electrolyte abnormalities, congestive heart failure, bradyarrhythmias or use of other medicines that can lead to either QT prolongation or electrolyte abnormalities.
5. Hypokalemia, hypomagnesemia, and hypocalcemia should be corrected prior to ondansetron administration.
Health Canada reminded that there are no changes to recommended oral dosing of Zofran in adults and no changes to recommended oral or intravenous dosing in children.
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/dhp-mps/medeff/../zofran_hpc-cps-eng.php
In Hong Kong, there are 24 registered pharmaceutical products containing ondansetron and are prescription-only medicines. Seven of them are injection products. Related news has been released by the FDA and MHRA, and was posted on the website of Drug Office on 16 September 2011, 30 June 2012 and 3 August 2012. Letters to inform healthcare professionals were issued on 16 September 2011 and 3 July 2012. The issue was preliminary 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. The matter related to dosage will be further discussed in the meeting of the Committee.
Ends/ Wednesday, October 10, 2012
Issued at HKT 14:00 |
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