Safety information on the risk of blood clots with immunoglobulin products

Starting date:

October 9, 2014

Posting date:

October 9, 2014

Type of communication:

Information Update

Subcategory:

Biologic/vaccine

Source of recall:

Health Canada

Issue:

Important Safety Information, New safety information, Product Safety

Audience:

General Public

Identification number:

RA-41783

• 
  Issue
• 
  What you should do
• 
  Report health or safety concerns
• 
  Related AWRs
• 
  Media enquiries
• 
  Public enquiries

Issue

Health Canada is informing Canadians that, following a safety review, the prescribing information (product monograph) for all immunoglobulin products has been updated to strengthen warnings on the rare but serious risk of blood clots.

Immunoglobulins are injectable products mainly administered by health professionals in healthcare settings such as hospitals or clinics. In some cases, patients can self-administer immunoglobulins at home. Several immunoglobulin products are authorized in Canada: GamaSTAN S/D, Gammagard liquid, Gammagard S/D, Gamunex, Hizentra, IGIVnex, Immune Serum Globulin (Human), Octagam (5% and 10%), and Privigen.

Immunoglobulins are used to treat a wide variety of conditions such as hereditary immune deficiencies, Guillain-Barré Syndrome, and Idiopathic Thrombocytopenic Purpura (a condition that can lead to easy or excessive bruising and bleeding, usually caused by low blood platelets).

Blood clots can sometimes result in heart attack and stroke. While blood clots are a known risk with immunoglobulins injected into a vein and product labelling already warns of this risk, a growing body of data suggests the risk exists with other routes of administration (injected into the muscle or under the skin) as well.

Blood clots have been reported in patients with and without risk factors, and can occur regardless of immunoglobulin dose or route of administration (injection into a muscle, vein or under the skin). Health Canada has worked with companies to ensure that all products contain prominent and consistent warning information and recommendations to help increase awareness and reduce the occurrence of blood clots.

What you should do

• Before starting an immunoglobulin, advise your healthcare professional if you have risk factors for blood clots. Risk factors for blood clots include obesity, advanced age, high blood pressure, diabetes, prolonged periods of immobilisation, use of estrogens, a history of heart disease, blood clots or blood clotting disorders, long-term catheters (tubes) that go into a central vein, or diseases that thicken the blood.
• Tell your healthcare professional if you have any signs or symptoms of a blood clot during or after receiving treatment. Symptoms include pain and swelling in the legs (including the ankle and foot), shortness of breath or chest pain.
• Talk to your healthcare professional with any questions or concerns about your immunoglobulin treatment.

A notice has been sent to health professionals to inform them of the updated warnings and risk factors associated with blood clots. Health Canada has also published a Summary Safety Review with more information on its review of immunoglobulins and the risk of blood clots.

Report health or safety concerns

To report a side effect to a health product to Health Canada:

• Call toll-free at 1-866-234-2345
• Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

Related AWRs

Non-Hyperimmune Immunoglobulin Products - Changes to Canadian Product Monographs - Notice to Hospitals

2014-10-09 | Health products

Advisory

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866 225-0709