FDA Warns that MS Patient Treated with Tecfidera Dies from Rare Brain Infection By Tod Aronovitz | 12/05/14 | 0 Comment

The U.S. Food and Drug Administration (FDA) is warning the public about a case in which a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate) developed a rare and serious brain infection and later died.

According to the FDA announcement, the infection, called progressive multifocal leukoencephalopathy or PML, is caused by the John Cunningham virus.  This virus is normally harmless in most people; however, those with compromised immune systems may go on to develop PML.  Symptoms of PML may cause progressive weakness on one side of the body, clumsiness, vision problems, confusion, and changes in thinking, personality, memory, and orientation.  In the most serious cases, the progression of PML can lead to severe disability or even death.

Tecfidera is manufactured by global biotechnology company Biogen Idec.  In March 2013, the FDA approved Tecfidera to treat relapsing forms of MS. The drug has been shown to benefit patients during time periods when their MS symptoms worsen, including greater episodes of weakness, numbness, and other nervous system disabilities.

Biogen Idec had notified the FDA when the MS patient died after developing PML. The 54-year old female had taken Tecfidera for more than four years and had an 18-year history of MS.  Before developing PML, she had a very low number of lymphocytes which may have contributed to a weakened immune system, but was not taking any other drugs at the time that would have affected her immune system or were thought to be associated with PML.

Currently, it is not known if the low lymphocyte count contributed to the development of PML in this patient, or if low lymphocyte counts are a risk factor for PML development in Tecfidera-treated patients in general.  As a result, the FDA is adding information about this case of PML to the Tecfidera drug label.

Patients should not stop taking Tecfidera without consulting with their healthcare professionals first.  They are urged to immediately report any symptoms that may suggest PML to their doctors.  Symptoms of PML are diverse, progress over days to weeks, and include:

  • Progressive weakness on one side of the body
  • Clumsiness of limbs
  • Disturbance of vision
  • Changes in thinking, memory and orientation
  • Confusion and personality changes

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: fda.gov/MedWatch/report.htm.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

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