Safety advice on particular drugs or classes of drugs
|
| |
| Canada: Tecfidera (dimethyl fumarate): New Safety Information Regarding the Risk of Progressive Multifocal Leukoencephalopathy |
| |
Biogen Idec Canada Inc., in consultation with Health Canada, announced that new safety information regarding the risk of progressive multifocal leukoencephalopathy (PML) is being added to the Tecfidera Canadian Product Monograph. The update was prompted by a fatal case of PML reported in a clinical trial patient receiving Tecfidera.
Tecfidera is approved for the treatment of relapsing remitting multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the progression of disability. A fatal case of PML was reported in a patient with severe and prolonged lymphopenia (lymphocyte counts predominantly <0.5x109/L for 3.5 years). The patient had no other medical conditions that could have compromised immune system functions and had not been taking any other immunosuppressive or immunomodulatory medications concomitantly.
The Product Monograph for Tecfidera is being updated to include the risk of PML. Given that a contributory role of Tecfidera -induced lymphopenia in the development of PML cannot be excluded, the Product Monograph update will also recommend close lymphocyte monitoring.Complete blood counts, including lymphocyte counts, should be obtained prior to treatment with Tecfidera, then every 6 to 12 months and as clinically indicated. Interruption of Tecfidera should be considered in patients with lymphocyte counts <0.5 X 109/L persisting for more than 6 months. After the interruption of Tecfidera, lymphocyte counts should be followed until recovery.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../43625a-eng.php
In Hong Kong, there is no registered pharmaceutical product containing dimethyl fumarate.
Ends/ Saturday, February 7, 2015
Issued at HKT 12:00
|
| |
|
