FERAHEME (ferumoxytol) - New Restrictions on the Use due to Information on Serious Allergic Reactions - For Health Professionals
- Starting date:
- July 11, 2014
- Posting date:
- July 11, 2014
- Type of communication:
- Dear Healthcare Professional Letter
- Source of recall:
- Health Canada
- Important Safety Information
- Healthcare Professionals
- Identification number:
This is duplicated text of a letter from Takeda Canada Inc. Contact the company for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Safety Information on FERAHEME (ferumoxytol)
July 11, 2014
Dear Health Care Professional:
Subject: Important new restrictions related to the use of FERAHEME® (ferumoxytol) due to serious hypersensitivity reactions
Takeda Canada Inc., in collaboration with Health Canada, would like to inform you of important new restrictions on the use of FERAHEME® (ferumoxytol), an intravenous iron product, authorized in Canada for the treatment of iron deficiency anaemia in adult patients with chronic kidney disease (CKD).
The Product Monograph (PM) has been revised to reflect new usage restrictions in patients treated with FERAHEME® (ferumoxytol).
- FERAHEME® is now contraindicated in patients with any allergy to other parenteral iron products or in patients with multiple (two or more) drug allergies.
Health care professionals are also reminded that:
- Serious hypersensitivity reactions including life threatening and fatal anaphylaxis/anaphylactoid reactions have occurred in patients receiving intravenous iron products including FERAHEME®.
- FERAHEME® should only be administered when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
- Patients should be closely monitored for signs and symptoms of hypersensitivity, including clinically significant hypotension, during and for at least 30 minutes after each administration of FERAHEME®.
- Before each administration patients should be informed of the risk of hypersensitivity. Patients should also be informed of the relevant symptoms and asked to seek urgent medical attention if a reaction occurs.
In CKD clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of patients receiving FERAHEME®. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of these patients. In another non-CKD clinical study, moderate to severe hypersensitivity reactions were reported in 2.5% (10/406) of patients treated with FERAHEME® and in 1.0% (2/199) treated with iron sucrose.
Anaphylactic type reactions presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have also been reported in the post-marketing setting, including a cluster of more than 20 serious reactions reported in Canada (2 with a fatal outcome) in less than a year. Among these post-marketing reports from Canada, many patients who experienced serious hypersensitivity reactions immediately after treatment with FERAHEME® had documented allergies to other intravenous iron products or multiple (two or more) drug allergies. In clinical studies, patients with any allergy to other iron products or multiple (two or more) drug allergies were excluded. These patients may be at increased risk of hypersensitivity reactions associated with FERAHEME®; FERAHEME® is contraindicated in these patients.
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 serious hypersensitivity or other serious or unexpected adverse reactions in patients receiving FERAHEME® should be reported to Takeda Canada Inc. or Health Canada.
Takeda Canada Inc.
435 North Service Road West, 1st Floor
Oakville, ON L6M 4X8
To correct your mailing address or fax number, contact Takeda Canada Inc.
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
- Calling toll-free at 1-866-234-2345; or
- Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
original signed by
Dr. Brad Pamenter
Vice President, Medical and Scientific Affairs
Takeda Canada Inc.
FERAHEME® is a registered trademark of AMAG Pharmaceuticals, Inc. and used under license by Takeda Canada Inc.
For more informationFurther to a Health Canada safety assessment of clinical and post-marketing data that includes a cluster of Canadian reports of serious hypersensitivity reactions, the Product Monograph (PM) has been revised to reflect new usage restrictions in patients treated with FERAHEME® (ferumoxytol).
- Date modified: