Second case of PML reported in MS patient taking Tecfidera

Biogen Idec has reported another case of progressive multifocal leukoencephalopathy (PML) in a patient taking Tecfidera (dimethyl fumarate) to the FDA.

PML is a rare, opportunistic infection of the brain that occurs in people who have compromised immune systems and have been infected with the John Cunningham (JC) virus. PML is also known to occur in patients taking Tysabri.

Currently, few details about this new patient are being released, but we do know that it is “non-fatal” and that the patient has been diagnosed with primary progressive multiple sclerosis. Further, he or she had prolonged severe lymphopenia, which is recognized in the  label for Tecfidera as a potential risk for PML. This new case is similar to the first reported case of PML in a patient who was taking Tecfidera. In the first reported case, the patient was a 54-year-old woman with MS who had a severe case of lymphopenia for 3.5 years.

Tecfidera has been on the market in the US since early 2013. A representative of Biogen Idec stated she does not anticipate any label changes to the drug at this time, but physicians should be vigilant about prolonged severe lymphopenia.1

To learn more about the first case of PML in a patient taking Tecfidera, read Lisa’s article, Biogen says MS Patient on Tecfidera who developed PML suffered longterm lymphopenia.

To learn more about PML, here is Stephanie’s article, MS 101: Understanding PML and the JC Virus.

As always, it is important to discuss any concerns you may have about your treatment regimen with your doctor.

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