REMERON / REMERON RD (mirtazapine) - Abnormal Heart Rhythm - For the Public
- Starting date:
- March 28, 2014
- Posting date:
- March 28, 2014
- Type of communication:
- Public Communication
- Source of recall:
- Health Canada
- Important Safety Information
- General Public
- Identification number:
This is duplicated text of a letter from Merck Canada Inc. Contact the company for a copy of any references, attachments or enclosures.
PUBLIC COMMUNICATION - Health Canada Endorsed Important Safety Information on REMERON / REMERON RD (mirtazapine)
March 28, 2014
Subject: Association of REMERON® / REMERON RD® (mirtazapine) and abnormal heart rhythm
Merck Canada Inc., in consultation with Health Canada, would like to inform you of important safety information about REMERON® / REMERON RD® (mirtazapine) and abnormal heart rhythm. REMERON® / REMERON RD® is a medication given for depression.
- Cases of abnormal heart rhythm or irregular heartbeats have been reported in patients on REMERON® / REMERON RD®. You are more at risk if you take other drugs known to cause heart rhythm problems and in the case of REMERON®/REMERON RD® overdose.
- The REMERON®/REMERON RD® product information has been changed to include this new information.
- It is important to tell your doctor if you have heart problems or if you have any family history of heart problems or if you take any other drugs with REMERON®/REMERON RD®.
Patients with these abnormal heart rhythms may feel dizzy, faint or have seizures. It may cause death if not treated.
Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing side effects are generally presumed to underestimate the risks associated with health product treatments. Any case of serious QT Prolongation/torsades de pointes or other serious or unexpected side effects in patients receiving REMERON®/REMERON RD® should be reported to Merck Canada Inc. or Health Canada.
Merck Canada Inc., Pharmacovigilance
16750 Trans-Canada Hwy.
Kirkland, Québec H9H 4M7
You can report any suspected side effect associated with the use of health products to Health Canada by:
Calling toll-free at 1-866-234-2345; or
- Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
original signed by
Mauricio Ede, M.D./
Executive Director, Medical Affairs
®Registered trademark of Merck Sharp & Dohme B.V. Used under license.