ADR that result in revision of patient information
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| Canada: Safety information on the risk of blood clots with immunoglobulin products |
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Health Canada is informing the public and healthcare professionals 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.
Before starting an immunoglobulin, patients should advise their healthcare professionals if they 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. And they should tell their healthcare professionals if they 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.
Please refer to the following website in Health Canada for details:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../41783a-eng.php
In Hong Kong, there are 35 registered pharmaceutical products containing immunoglobulin. Related news had been released by the US FDA and were posted on the Drug Office website on 14 November 2012, 11 June 2013 and 16 November 2013. Letter to inform local healthcare professionals to draw their attention on the above safety warning, and urge them to report any adverse drug reaction related to the drugs was issued on 14 November 2012. The matter was discussed by the Registration Committee of the Pharmacy and Poisons Board (the Committee) in April 2013. The Committee decided that the sales pack labels and/or package inserts of registered pharmaceutical products containing immunoglobulin should include new safety warning on the risk of thrombosis.
Ends/ Friday, October 10, 2014
Issued at HKT 12:30
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