FERAHEME (ferumoxytol) - New Restrictions on the Use due to Information on Serious Allergic Reactions - For the Public
- Starting date:
- July 11, 2014
- Posting date:
- July 11, 2014
- Type of communication:
- Public Communication
- Source of recall:
- Health Canada
- Important Safety Information
- General Public
- 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.
PUBLIC COMMUNICATION - Health Canada Endorsed Important Safety Information on FERAHEME (ferumoxytol)
July 11, 2014
Subject: Important new restrictions on the use of FERAHEME® (ferumoxytol) due to information on serious allergic reactions
Takeda Canada Inc., in collaboration with Health Canada, would like to inform you of important new restrictions on the use of FERAHEME® due to information on serious allergic reactions.
FERAHEME® (ferumoxytol) is an iron product that is given by injection into a vein. It is authorized in Canada for the treatment of iron deficiency anaemia in adult patients with chronic kidney disease (CKD).
- FERAHEME® should no longer be used in patients who are allergic to other iron products given by injection or infusion, or in patients with multiple drug allergies.
Patients are also reminded that:
- allergic reactions including life-threatening and sometimes fatal reactions (anaphylaxis) have occurred with the use of FERAHEME®.
- FERAHEME® should only be given in a setting where appropriate personnel and therapies for the treatment of severe allergic reactions are also immediately available.
Among Canadian patients who experienced serious allergic reactions immediately after treatment with FERAHEME®, some had already had allergies to other iron products given by intravenous injection, or multiple (two or more) drug allergies. Also, the safety of using FERAHEME in these patients has not been studied. Therefore, patients with any allergy to other iron products given by injection or infusion, or with multiple (two or more) drug allergies may be at increased risk of allergic reactions associated with FERAHEME®; FERAHEME® should not be used in these patients.
Takeda Canada Inc. has worked with Health Canada to update the safety information for FERAHEME® and has sent a letter to health care professionals to inform them of this new safety information. A copy of that letter is available on the Health Canada Web site.
Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious allergic reactions or other serious or unexpected side effects 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
You can report any suspected side effect 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: