Health Canada endorses further updates to Tysabri safety info
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Health Canada endorses further updates to Tysabri safety info In consultation with Health Canada, Biogen Idec has issued a ‘Dear Healthcare Professional’ letter1 in conjunction with a Public Communication2 notifying patients and prescribers about further updates to the safety information for Tysabri (natalizumab). The Product Monograph, Warnings and Precautions, and the Consumer Information sections of the labelling have been updated with additional information regarding the associated risk of progressive multifocal leukoencephalopathy (PML). The risk of developing PML increases with increasing duration of treatment. Prescribers are advised that continued clinical vigilance and close monitoring for signs and symptoms of PML is necessary. After 24 infusions, the risks and benefits of continuing natalizumab treatment should be rediscussed with the patient. Canadian patients who are prescribed Tysabri are to be registered with the Tysabri Care Program – a registry associated with the prescribing, administration and monitoring of patients receiving Tysabri therapy. As of 6 April 2010, 46 confirmed cases of PML had been reported worldwide. Post-marketing data shows that the incidence of PML in patients with > 2 years exposure is 1.59 per 1000 patients (95% CI 1.11, 2.21). This appears to be higher than the rate of approximately 1 per 1000 patients reported in clinical trials. As of yet, there are limited data regarding the risks associated with > 3 years exposure. 1. Biogen Idec Canada Inc. Updated Safety Information regarding Progressive Multifocal Leukoencephalopathy (PML) associated with TYSABRI (Rm) (natalizumab). Internet Document : [2 pages], 12 May 2010. Available from: URL: http://www.hc-sc.gc.ca. 2. Biogen Idec Canada Inc. New Information on the risk of Progressive Multifocal Leukoencephalopathy (PML) with TYSABRI (Rm) (natalizumab). Internet Document : [2 pages], 12 May 2010. Available from: URL: http://www.hcsc.gc.ca. 801140516
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Reactions 22 May 2010 No. 1302
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