Other safety alerts
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| Canada: Association of REMERON® / REMERON RD® (mirtazapine) with QT Prolongation/Torsades de Pointes |
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Merck Canada Inc., in consultation with Health Canada, informed healthcare professionals and the public of new warnings for REMERON® and REMERON RD® (mirtazapine) regarding post marketing cases of QT prolongation and torsades de pointes reported with the use of mirtazapine. REMERON® / REMERON RD® is indicated for the symptomatic relief of depressive illness.
Most cases occurred in association with drug overdose or in patients with other risk factors for QT prolongation, including concomitant use of QT prolonging medications. The Product Monograph has been updated to include this information and to advise caution in patients with risk factors such as known cardiovascular disease, family history of QT prolongation and concomitant use of QT prolonging medications. Monitoring of vital signs and cardiac rhythm should be undertaken in the management of mirtazapine overdose.
Patients with torsades de pointes may present with dizziness, palpitations, syncope, or seizures. If sustained, torsades de pointes can progress to ventricular fibrillation and sudden cardiac death.
Please refer to the following website in Health Canada for details:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../38709a-eng.php
In Hong Kong, there are 24 registered pharmaceutical products containing mirtazapine. They are prescription only medicines. In view of the Health Canada’s announcement, a letter to healthcare professionals will be issued and the matter will be discussed in the meeting of Registration Committee of the Pharmacy and Poisons Board.
Ends/ Saturday, March 29, 2014
Issued at HKT 12:00
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