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

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Contact: Marketed Health Products Directorate (MHPD)

Health Canada Endorsed Important Safety Information on TELZIR (fosamprenavir)

July 17, 2009

Dear Health Care Professional,

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

GlaxoSmithKline, in consultation with Health Canada, would like to inform you of important safety information regarding a potential association between myocardial infarction 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 presented at the 16^th Conference on Retroviruses and Opportunistic Infections (CROI 2009) suggested a potential association between fosamprenavir and myocardial infarction in HIV infected adults. The nested case-control study reported an increased risk of myocardial infarction in association with cumulative exposure to fosamprenavir (OR, 1.55 per additional year of exposure; 95% CI, 1.20-1.99).¹ Myocardial infarction has already been identified as being potentially associated with the PI class in the ongoing Data Collection on Adverse Events of Anti-HIV Drugs (DAD).²

Suppression of viral replication in HIV disease with antiretroviral therapy is of the utmost importance. Physicians should monitor a patient's cardiovascular risk as part of the follow-up and seek to adjust modifiable risk factors. Combination antiretroviral therapy is associated with redistribution of body fat (lipodystrophy) in HIV-infected patients. Clinical examination should include evaluation for physical signs of fat distribution. HIV infection itself has been associated with lipid disorders and ischaemic heart disease.

GSK will be working with Health Canada on this issue to integrate new safety information in the Canadian Product Monograph.

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 or other serious or unexpected adverse reactions in patients receiving TELZIR^® Tablets and Oral Solution should be reported to GlaxoSmithKline 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

Sincerely,

original signed by

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