ADR that result in revision of patient information
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| Canada: FERAHEME (ferumoxytol) - New Restrictions on the Use due to Information on Serious Allergic Reactions |
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Takeda Canada Inc., in collaboration with Health Canada, inform the healthcare professionals of the important new restrictions on the use of FERAHEME (ferumoxytol), an intravenous iron product, authorized in Canada for the treatment of iron deficiency anaemia in adult patients with chronic kidney disease (CKD).
The Product Monograph (PM) has been revised to reflect new usage restrictions in patients treated with FERAHEME (ferumoxytol). FERAHEME® is now contraindicated in patients with any allergy to other parenteral iron products or in patients with multiple (two or more) drug allergies.
Health care professionals are also reminded that:
- Serious hypersensitivity reactions including life threatening and fatal anaphylaxis/anaphylactoid reactions have occurred in patients receiving intravenous iron products including FERAHEME.
- FERAHEME should only be administered when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
- Patients should be closely monitored for signs and symptoms of hypersensitivity, including clinically significant hypotension, during and for at least 30 minutes after each administration of FERAHEME.
- Before each administration patients should be informed of the risk of hypersensitivity. Patients should also be informed of the relevant symptoms and asked to seek urgent medical attention if a reaction occurs.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../40505a-eng.php
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Saturday, July 12, 2014
Issued at HKT 12:00
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