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Association of abacavir-containing medicinal products (ZIAGEN, KIVEXA and TRIZIVIR) with a potential increased risk of myocardial infarction - For the Public

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Contact: Marketed Health Products Directorate (MHPD)

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from GlaxoSmithKline.
Contact the company for a copy of any references, attachments or enclosures.

PUBLIC COMMUNICATION Health Canada Endorsed Important Safety Information on abacavir-containing medicinal products (ZIAGEN Tablets and Oral Solution; KIVEXA Tablets; TRIZIVIR Tablets)

June 23, 2008

Subject: Potential risk of cardiac events associated with ZIAGEN®, KIVEXA® and TRIZIVIR®

GlaxoSmithKline, in consultation with Health Canada, would like to provide you with new safety information regarding a potential increased risk of myocardial infarction (heart attack) associated with abacavir-containing medicinal products (ZIAGEN®, KIVEXA® and TRIZIVIR®).

Abacavir is an antiretroviral medication used in combination with other antiretrovirals in the treatment of human immune deficiency syndrome virus (HIV) infection.

A study recently published in The Lancet1has raised concern about a potential increased risk of myocardial infarction (heart attack) in HIV-infected patients receiving abacavir-containing medicinal products. Further investigation of this study is necessary to confirm the association between the use of abacavir and an increased risk of myocardial infarction.

Important Information for Patients

  • Results from a study suggest that abacavir-containing products may be associated with a potential increased risk of myocardial infarction (heart attack) in HIV-infected patients.
  • Do not stop taking ZIAGEN®, KIVEXA® or TRIZIVIR® without first consulting your healthcare provider.
  • You should talk to your doctor if you have had pre-existing serious cardiovascular disease.

Healthcare professionals thoroughly consider the overall benefit versus the risk of a medication for each individual patient before prescribing. If patients have questions regarding their current prescription, they are asked to contact their doctor.

At this time, Health Canada has undertaken the review of this safety data and will advise Canadians if further risk measures are deemed necessary.

In the interim, it is recommended that patients taking abacavir-containing medicinal products (ZIAGEN®, KIVEXA® and TRIZIVIR®) consult with their healthcare professional before making any change to their medication, as HIV infection can lead to complications, if left untreated.

GlaxoSmithKline has sent a letter to relevant Canadian healthcare professionals informing them of this new safety information. You may view this letter on the Next link will take you to another Web site Canadian website of GSK or on the Health Canada website.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. As always, any serious or unexpected adverse reactions in patients receiving ZIAGEN®, KIVEXA® and TRIZIVIR® should be reported to GlaxoSmithKline or Health Canada at the following addresses:

Next link will take you to another Web site GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Tel.: 1-800-387-7374

Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
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
CanadaVigilance@hc-sc.gc.ca

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

For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: MHPD_DPSC@hc-sc.gc.ca
Tel.: 613-954-6522
Fax: 613-952-7738

For media inquiries, please contact GSK Corporate Communications, 905-819-3363.

Sincerely,

original signed by

Dr. Tjark Reblin, MD, MBA
Vice President, Medical Division and Chief Medical Officer
GlaxoSmithKline Inc.

References:
1. D:A:D Study Group, Sabin CA, Worm SW, Weber R, et al. (2008) Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients enrolled in the D:A:D study: a multi-cohort collaboration. Lancet. Apr 26; 371(9622):1417-26.

Comment in:
Lancet. 2008 Apr 26; 371(9622):1391-2.
Lancet. 2008 Apr 26; 371(9622):1413.

®KIVEXA and TRIZIVIR are registered trademarks, used under license by GlaxoSmithKline Shire Canada
®ZIAGEN is a registered trademark, used under license by GlaxoSmithKline Inc.

Date Modified: 2007-03-28

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