Tecfidera (dimethyl fumarate) by Biogen Idec: Drug Safety Communication - Case of Rare Brain Infection PML Reported[Posted 11/25/2014]
ISSUE: 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.
See the FDA Drug Safety Communication for additional clinical information about this case.
- Tecfidera is a drug used to treat relapsing forms of multiple sclerosis (MS), a brain and spinal cord disease in which patients experience multiple episodes of weakness, numbness, and other nervous system signs and symptoms that partially or completely resolve overs weeks or months. Patients may develop persistent symptoms and disability over time.
- Approximately 4,000 patients have taken Tecfidera in MS clinical trials, including 1,000 patients treated for at least 4 years. Biogen reports that more than 100,000 patients with MS worldwide have taken Tecfidera since FDA approved it in 2013.