Archived - Important Safety Information regarding ZOLOFT (sertaline hydrochloride) Pfizer Canada Inc. - Health Professional Advisory

Starting date:

February 28, 2003

Posting date:

February 28, 2003

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-17000625

February 28, 2003

IMPORTANT SAFETY INFORMATION REGARDING ZOLOFT* (sertraline hydrochloride)

Dear Health Care Professional(s),

Pfizer Canada Inc. in consultation with Health Canada, would like to inform you of clinically important safety information and upcoming changes to the Product Monograph for ZOLOFT* [sertraline hydrochloride] capsules.

The concomitant use of ZOLOFT (sertraline hydrochloride) and pimozide is contraindicated as ZOLOFT has been shown to increase plasma pimozide levels. Elevation of pimozide blood concentration may result in QT interval prolongation and severe arrhythmias including Torsade de Pointes.

Based upon the results of a study entitled, "Phase 1 Open Study Designed to Determine the Potential Interaction of Sertraline With Cisapride or Pimozide in Healthy Male and Female Subjects", the ZOLOFT Product Monograph will be revised to include the following new information:

In a controlled study of a single dose (2 mg) of pimozide, 200 mg sertraline (q.d.) co-administration to steady state was associated with a mean increase in pimozide AUC and Cmax of about 40%. Although these increases were not identified in the trial as being associated with clinically important effects on QT intervals, the trial design was not optimal for the investigation of pharmacodynamic effects in the clinical setting.

Since the highest recommended pimozide dose (12 mg) has not been evaluated in combination with sertraline, the effect on QT interval and PK parameters at doses higher than 2 mg at this time are not known. While the mechanism of this interaction is unknown, due to the narrow therapeutic index of pimozide and due to the interaction noted at a low dose of pimozide, concomitant administration of ZOLOFT (sertraline hydrochloride) and pimozide is contraindicated.

We trust this information is useful in providing guidance on the appropriate use of sertraline concomitantly with pimozide.

Pfizer Canada Inc is committed to providing you with the most current product safety information on its products and routinely assesses safety information and updates Product Monographs accordingly.

Reporting rates determined on the basis of spontaneously reported post-marketing adverse events are generally presumed to underestimate the risks associated with drug treatments.

The identification, characterization, and management of drug-related adverse events are dependent on the active participation of health care professionals in adverse drug reaction reporting programmes. Health care professionals are asked to report any suspected adverse reactions in patients receiving ZOLOFT (sertraline hydrochloride) to Pfizer Canada Inc. at the following address:

Pfizer Canada Inc.

Safety and Medical Information

P.O. Box 800

Pointe-Claire, Quebec

H9R 4V2

1-800-463-6001

Your professional commitment in this regard has an important role in protecting the well- being of your patients by contributing to early signal detection and informed drug use.

Sincerely,

original signed by

Bernard Prigent, M.D.

Vice President & Medical Director

Pfizer Canada Inc.

*Trade-mark Pfizer Inc.

Pfizer Canada Inc., Licensee

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.