Archived - Concomitant Use of Paxil (paroxetine hydrochloride) or Paxil CR (paroxetine hydrochloride controlled release tablets) and pimozide (Orap) Resulting in Arrhythmias (Irregular Heartbeats)

PUBLIC ADVISORY

Health Canada Endorsed Important Safety Information on the Concomitant Use of PAXIL (paroxetine hydrochloride) or PAXIL CR (paroxetine hydrochloride controlled release tablets) and pimozide (Orap) Resulting in Arrhythmias (Irregular Heartbeats)

GlaxoSmithKline Inc.

7333 Mississauga Road North

Mississauga, Ontario

Canada L5N 6L4

July 28, 2005

Subject: Important New Safety Information for the Use of PAXIL^® (paroxetine hydrochloride) and PAXIL CR™ (paroxetine hydrochloride controlled release tablets) in patients taking pimozide

GlaxoSmithKline Inc., following discussions with Health Canada, is informing patients of new safety information regarding Paxil and Paxil CR, both of which are medications used for treating the symptoms of depression and anxiety.

Based on the results of a recent clinical study, Paxil or Paxil CR must not be used together with pimozide (Orap^®), an antipsychotic medication. Patients are advised NOT to take Paxil or Paxil CR with pimozide as their interaction increases the level of pimozide in the blood, which may result in arrhythmias (irregular heartbeats), that can sometimes be serious and even life-threatening. Patients should be aware that the symptoms of 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.

GlaxoSmithKline has sent a letter to healthcare professionals informing them of this new safety information. This information may be obtained on the Canadian website of GlaxoSmithKline (http://www.gsk.ca) or on the website of the Therapeutic Products Directorate of Health Canada (http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/index-eng.php). Following consultation with Health Canada, the Canadian prescribing information and consumer information for Paxil and Paxil CR has been revised. If patients have questions regarding their current Paxil or Paxil CR prescription, they are asked to contact their doctor or pharmacist.

For media inquiries, please contact Cathy Metson or Alison Steeves, (905) 819-3363.

The identification, characterization, and management of marketed health product-related adverse reactions are dependent on the active participation of health care professionals in adverse reaction reporting programmes. Any occurrences of serious and/or unexpected adverse reactions in patients receiving PAXIL^® or PAXIL CR™ should be reported directly to GSK or Health Canada at the following addresses:

GlaxoSmithKline Inc.

7333 Mississauga Road North

Mississauga, Ontario L5N 6L4

Tel: 1-800-387-7374

Any suspected adverse reaction can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0701C

OTTAWA, Ontario, K1A 0K9

Tel: (613) 957-0337 or Fax: (613) 957-0335

To report an Adverse Reaction, consumers and health professionals may call toll free: Tel: 866 234-2345

Fax: 866 678-6789

cadrmp@hc-sc.gc.ca

For other inquiries, please refer to contact information:

Bureau of Cardiology, Allergy and Neurological Sciences (BCANS)

BCANS_Enquiries@hc-sc.gc.ca

Tel: (613) 941-1499

Fax: (613) 941-1668

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.