Other safety alerts
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| The United States: Tecfidera (dimethyl fumarate) by Biogen Idec: Drug Safety Communication - Case of Rare Brain Infection PML Reported |
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FDA is warning that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate) developed a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML), and later died. The patient who died was not taking any other drugs that affect the immune system or drugs that are thought to be associated with PML. As a result, information describing this case of PML is being added to the Tecfidera drug label.
PML is a rare and serious brain infection caused by the John Cunningham (JC) virus. The JC virus is a common virus that is harmless in most people but can cause PML in some patients who have weakened immune systems.
Healthcare professionals should:
Tell patients taking Tecfidera to contact them if patients develop any symptoms that may be suggestive of progressive multifocal leukoencephalopathy (PML). Symptoms of PML are diverse, progress over days to weeks, and include the following: progressive weakness on one side of the body or clumsiness of limbs; disturbance of vision; and changes in thinking, memory and orientation, leading to confusion and personality changes. The progression of deficits can lead to severe disability or death.
Stop Tecfidera immediately at the first sign or symptom suggestive of PML and perform an appropriate diagnostic evaluation.
Monitor lymphocyte counts in Tecfidera-treated patients according to approved labeling.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm424752.htm
In Hong Kong, there is no registered pharmaceutical product containing dimethyl fumarate.
Ends/ Wednesday, November 26, 2014
Issued at HKT 13:00
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