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Association of TELZIR (fosamprenavir) with a potential increased risk of myocardial infarction (heart attack) - For the Public

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Contact: Marketed Health Products Directorate (MHPD)

PUBLIC COMMUNICATION
Health Canada Endorsed Important Safety Information on TELZIR (fosamprenavir)

July 17, 2009

Subject: Potential association of myocardial infarction (heart attack) in patients treated with ^PRTELZIR^®(fosamprenavir).

GlaxoSmithKline Inc. (GSK), in consultation with Health Canada, would like to inform you of important safety information regarding a potential association between myocardial infarction (heart attack) and exposure to ^PRTELZIR^® (fosamprenavir) in HIV-infected patients.

Fosamprenavir is a protease inhibitor (PI) used in combination with low-dose ritonavir and other antiretrovirals in the treatment of HIV-1 infection.

Recent data has suggested a potential association between fosamprenavir and myocardial infarction (heart attack) in HIV-infected adults.¹

Myocardial infarction (heart attack) has already been identified as being potentially associated with the PI class in an ongoing population study.²

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 should contact their doctor.

It is recommended that patients taking ^PRTELZIR^® consult with their healthcare provider before making any change to their medication, as HIV infection can lead to complications, if left untreated.

GlaxoSmithKline is working with Health Canada to update the prescribing information for ^PRTELZIR^® and has, in consultation with Health Canada, sent a letter to relevant Canadian healthcare professionals informing them of this new safety information.  You may view this letter on the 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.  Any case of myocardial infarction (heart attack) or other serious or unexpected adverse reactions in patients receiving TELZIR^® Tablets and Oral Solution should be reported to GlaxoSmithKline Inc. or Health Canada at the following addresses:

GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Telephone: 1-800-387-7374
www.gsk.ca

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
Telephone: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 1-866-234-2345
Fax: 1-866-678-6789
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
Telephone: 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.

^® TELZIR is a registered trademark, used under license by GlaxoSmithKline Inc.