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

Starting date:

July 17, 2009

Posting date:

July 22, 2009

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000806

This is duplicated text of a letter from GlaxoSmithKline Inc.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

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 ^{Footnote ®} (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.^{Footnote 1}

Important Information for Patients

• Results from a study suggest that exposure to fosamprenavir may be associated with an increased risk of myocardial infarction (heart attack) in HIV-infected patients.^{Footnote 1}
• Do not stop taking ^PRTELZIR^® without first consulting your healthcare provider.
• You should talk to your doctor about how to help manage risk factors for heart disease (such as high blood pressure, diabetes and smoking).

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

References: