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Archived – New Safety Information Associated with the Use of Zoloft in Patients Taking Pimozide – For the Public
- Starting date:
- March 5, 2003
- Posting date:
- March 5, 2003
- Type of communication:
- Public Communication
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Issue:
- New safety information
- Audience:
- General Public
- Identification number:
- RA-19000115
This is duplicated text of a letter from Pfizer Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.
Notice about Health Canada advisories
The concomitant use of ZOLOFT and pimozide is contraindicated.
KIRKLAND, QUEBEC - March 5, 2003 - Pfizer Canada Inc. in consultation with Health Canada has informed Canadian health care professionals of clinically important new safety information concerning ZOLOFT [sertraline hydrochloride] capsules, a drug prescribed by physicians to relieve symptoms of depression, panic disorder or obsessive-compulsive disorder.
Based on the result of a recent clinical study, the concomitant use of ZOLOFT and pimozide (an antipsychotic medication) is now contraindicated. Patients are advised NOT to take ZOLOFT with pimozide as their interaction may result in arrhythmias (irregular heartbeats), which may be serious and life-threatening.
Patients should be aware that the symptoms of possible arrhythmia include dizziness, palpitations and fainting, and that they should seek immediate medical attention if these symptoms occur. If you are presently being treated with this drug combination, please consult your physician before changing your current therapy.
This advisory is in addition to a letter issued to health care professionals reminding them of the abovementioned safety information. As well, the product monograph for ZOLOFT is being revised to inform physicians regarding potential adverse effects this drug combination may cause.
If patients have questions regarding their current prescription, they are asked to contact their physician or pharmacist.
For additional information, please contact:
Rhonda O'Gallagher
Senior Manager, Corporate Affairs
Pfizer Canada Inc.
(514) 693-4090
Any suspected adverse reactions can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
Health Canada
Address Locator: 0201C2
OTTAWA, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
The AR Reporting Form and the AR Guidelines can be found on the TPD web site or in The Canadian Compendium of
Pharmaceuticals and Specialties.