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
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-40507

This is duplicated text of a letter from Takeda Canada 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 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.

The newly revised Product Monograph for FERAHEME® (ferumoxytol), which includes the above-mentioned information, can be accessed on the Web sites of Health Canada and Takeda Canada Inc.

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
Telephone: 1-866-295-4636

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
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Sincerely,

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 information

Further 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).