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Transplant Surgery Other
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my personal edition > transplant surgery other > news
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DGNews
Use of Mycophenolate Mofetil Associated With Pure Red Cell Aplasia, Warns Health Canada
OTTAWA, Ontario -- June 4, 2009 -- Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, is informing healthcare professionals regarding reports of pure red cell aplasia (PRCA) in patients treated with mycophenolate mofetil (CellCept) in combination with other immunosuppressive agents.
The mechanism for mycophenolate mofetil-induced PRCA is unknown. In some cases PRCA was found to be reversible with dose reduction or cessation of mycophenolate mofetil therapy. In transplant patients however reduced immunosuppression may place the graft at risk.
PRCA is usually treated by treating the underlying condition or discontinuing the drug that causes PRCA.
Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin. Anaemia is the primary clinical concern in PRCA. The degree of anaemia can range from subclinical to severe. Anaemia in acute self-limited PRCA is barely noticeable; however, profound anaemia can occur in chronic acquired PRCA and in congenital PRCA. Patients with severe anaemia have symptoms and signs of uncompensated anaemia and present with weakness, tachycardia, and dyspnoea.
As of 24 February 2008, 41 cases of PRCA have been reported in patients receiving mycophenolate mofetil in combination with other immunosuppressive agents (tacrolimus, cyclosporine, corticosteroids, azathioprine, sirolimus and alemtuzumab), and the data related to these case reports have been reviewed by Health Canada.
Based on the preclinical in vivo evidence and post-marketing database, a causal contribution of mycophenolate mofetil on PRCA is considered possible in a few cases received.
The Canadian Product Monograph (CPM) for mycophenolate mofetil has been revised to include the above updated safety information.
Managing marketed health product-related adverse reactions depends on healthcare professionals and consumers reporting them. Any occurrence of serious and/or unexpected adverse reactions in patients receiving mycophenolate mofetil should be reported to Hoffmann-La Roche Limited or Health Canada at the following addresses:
Hoffmann-La Roche Limited
Drug Safety Department
2455 Meadowpine Boulevard
Markham, Ontario L6G 0B5
Mississauga, Ontario, L5N 6L7
or call toll free at: 1-888-762-4388
or Fax at: 905-542-5864
or e-mail to: mississauga.drug_safety@roche.com
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
Ottawa, Ontario, K1A 0K9
Tel: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 1-866-234-2345
Fax: 1-866-678-6789
CanadaVigilance@hc-sc.gc.ca
SOURCE: Health Canada
All contents Copyright (c) 1995-2009 Doctor's Guide Publishing Limited. All rights reserved.
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