Vivaglobin [Immune Globulin Subcutaneous (Human)] – Risk of Thrombotic Events (Blood Clots) – For the Public

Starting date:

April 11, 2011

Posting date:

April 11, 2011

Type of communication:

Public Communication

Subcategory:

Biologic/vaccine

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-190001021

This is duplicated text of a letter from CSL Behring 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 Vivaglobin

April 11, 2011

Subject: Risk of blood clots with the use of Vivaglobin^® [Immune Globulin Subcutaneous (Human)]

To Whom It May Concern,

CSL Behring Canada Inc, in collaboration with Health Canada, would like to inform you of reports of serious thrombotic events (blood clots) following the use of Vivaglobin^®, Immune Globulin Subcutaneous (Human).

Vivaglobin^® is used to treat adults and children with primary immune deficiency (PID), a condition in which a person's natural defense system or immune system is not functioning properly.

• Vivaglobin^® is a medication to be given only by injection under the skin (subcutaneously).
• Administration of Vivaglobin^® by any other route (for example into a vein) is not authorised and may increase the risk of blood clots.
• The symptoms of a blood clot include: difficulty breathing; pain and swelling of a limb; pain in the chest area; sudden difficulty in concentration, focus or balance or anything else that becomes suddenly unusual. See a doctor if you develop any of these symptoms.
• Certain conditions may increase your risk of blood clots. Consult your doctor if you have questions or concerns regarding the use of this product.

There have been very rare reports of blood clots associated with use of Vivaglobin^®. The risk of forming blood clots is well known for immune globulin products injected into veins, but has now been reported when injected under the skin. These events include deep vein thrombosis (blood clot in the legs), pulmonary embolism (blood clot in the lung), and stroke (blood clot in the brain). Nineteen thrombotic events were reported worldwide in patients treated with Vivaglobin^®, some of them following inappropriate injection into a vein; no cases have been reported in Canada.

Some of these patients had risk factors for blood clots, which included heart disease, previous blood clots, excess weight, use of birth control pills, high levels of protein and cholesterol in the blood, the use of a catheter, and immobility.

Vivaglobin^® is authorized to be given only by injection under the skin (subcutaneously). It is important that the instructions in the Patient Instructions provided with Vivaglobin^® and those given by your health-care provider, including particular symptoms to look for, be followed. There are risk factors such as dehydration, blood clotting disorders and heart disease that may increase the risk of clots forming in blood vessels during immunoglobulin replacement therapy. If you have any of these risk factors, please discuss with your health-care professional so that appropriate precautions be taken, including administering Vivaglobin^® at the slowest administration rate possible.

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 thrombotic events or other serious or unexpected adverse reactions in patients receiving Vivaglobin^® should be reported to CSL Behring or to Health Canada.

Please report any adverse event you encounter with a CSL Behring Product to CSL Behring U.S. Clinical Safety and Pharmacovigilance: 1-866-915-6958. Please provide the lot number(s) of products associated with reported adverse events whenever possible. 

CSL Behring Canada, Inc.

55 Metcalfe Street, Suite 1460

Ottawa, Ontario

K1P 6L5

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at MedEffect
• Call toll-free at 1-866-234-2345
• Complete a Reporting Form and:
  • Fax toll-free to 1-866-678-6789, or
  • Mail to: Canada Vigilance Program
    
    Health Canada
    
    Postal Locator 0701E
    
    Ottawa, Ontario   K1A 0K9

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section. The Reporting Form is also in the Canadian Compendium of Pharmaceuticals and Specialties.

For other health product inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate

E-mail: mhpd_dpsc@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738

Sincerely,

original signed by

David Barnes

Medical Director

CSL Behring Canada