ADR that result in revision of patient information
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| The United Kingdom: Dimethyl fumarate (Tecfidera): fatal progressive multifocal leukoencephalopathy in an multiple sclerosis patient with severe, prolonged lymphopenia |
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A fatal case of PML was reported in Germany in October 2014 in a patient participating in the open-label ENDORSE study of dimethyl fumarate in multiple sclerosis (MS). The patient received dimethyl fumarate for 4.5 years and experienced severe lymphopenia for more than 3.5 years. This is the only known case of PML associated with dimethyl fumarate in a multiple sclerosis patient to date. Cases of PML have been reported with the use of fumaric acid esters (including dimethyl fumarate) in lymphopenic patients with psoriasis. However, in some of these cases, it could not be confirmed that the treatment caused PML (eg other risk factors for PML may have been present).
The MHRA is advising healthcare professionals to check full blood counts before prescribing dimethyl fumarate and then every 6 to 12 months, and stop treatment immediately if they suspect progressive multifocal leukoencephalopathy (PML).
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/dimethyl-fumarate-tecfidera-fatal-pml-in-a-ms-patient-with-severe-prolonged-lymphopenia
In Hong Kong, there is no registered pharmaceutical product containing dimethyl fumarate. Related news has been released by the FDA and the Health Canada, and was posted on the Drug Office website on 26 November 2014 and 7 February 2015 respectively.
Ends/ Tuesday, March 31, 2015
Issued at HKT 16:00
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