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Association of Enbrel (etanercept) with Histoplasmosis and Other Invasive Fungal Infections - For the Public
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(PDF Version - 83 K)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 Amgen Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.
PUBLIC COMMUNICATION
Health Canada Endorsed Important Safety Information on ENBREL (etanercept)
April 21, 2009
Subject: Risk of Histoplasmosis and Other Serious Fungal Infections Associated with ENBREL® (etanercept)
Amgen Canada , on behalf of Immunex, in collaboration with Health Canada , wishes to inform the Canadian public of updated safety information regarding ENBREL® (etanercept).
ENBREL® is a medicine called a Tumor Necrosis Factor (TNF) blocker. It is currently authorized in Canada for the treatment of rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis and plaque psoriasis. It is estimated that over 500,000 patients have been administered ENBREL® worldwide.
Amgen Canada would like to alert the public to the risk of invasive fungal infections, including histoplasmosis, in patients taking TNF blockers, including ENBREL®. This is to help patients and their health care professionals better recognize and treat these infections.
- There have been reports of patients developing serious fungal infections, such as histoplasmosis, coccidioidomycosis, and blastomycosis, in the lung and sometimes, spreading throughout the body (invasive fungal infection) while taking TNF blockers, such as Enbrel®. In some patients, these types of fungal infections were not recognized at first, delaying treatment. Some of these patients died from invasive fungal infection.
- If you are taking a TNF blocker, you should tell your doctor if you develop symptoms, such as fever, tiredness, weight loss, sweats, cough, or difficulty in breathing. You should also tell your doctor if you live or work in, or have traveled to, areas where these infections are more common (see below).
Serious fungal infections such as histoplasmosis are non-contagious diseases caused by molds (fungus) usually found in the soil, or hay. Certain invasive fungal infections including histoplasmosis are seen most frequently in the central and eastern portions of the United States of America (U.S.A.) and in the Saint Lawrence River valley in Canada. Coccidioidomycosis is commonly found in the Southwestern portion of the U.S.A. The vast majority of people infected with this fungus have either no symptoms or mild flu-like symptoms that do not require medical attention, however, sometimes in people with weakened immune systems, the fungus can spread through the body and be fatal if untreated.
Patients with questions regarding their current treatment are asked to contact their doctor or pharmacist. The safety information in the Canadian Product Monograph (CPM) for ENBREL®, has been revised to highlight the risk of invasive fungal infection, and a letter has been sent to Canadian healthcare professionals to inform them of this update. A copy of that letter can be found on the Health Canada website. The CPM can be found on the 
Amgen website.
Detection of adverse reactions related to marketed health products, such as Enbrel®, depends in part on reports received from health care professionals and patients like you. The number of adverse events reported in the post-marketing setting for a marketed health product is generally presumed to underestimate the actual risk of that adverse event associated with marketed health product since many people fail to report such adverse events. Any case of serious fungal infection or other serious or unexpected adverse reactions in patients receiving ENBREL® should be reported to Amgen Canada or Health Canada at the following addresses:
6775 Financial Drive, Suite 100
Tel: (866) 512-6436;
Fax: (888) 264-3655
safetycanada@amgen.com
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: 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
This advisory is in addition to a letter issued to healthcare professionals discussing the above mentioned safety information. This letter can be accessed at the Health Canada website.
Sincerely,
original signed by
Andrew Vieira, MD
Medical Director, Inflammation
Amgen Canada
