Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
According to the FDA drug label for Tecfidera approved on December 3, 2014, only one case of progressive multifocal leukoencephalopathy (PML) was found to be linked to the multiple sclerosis (MS) drug, Tecfidera (dimethyl fumarate), manufactured by Biogen, Inc.
However, a fourth case was recently reported in December 2015, which led to an increased warning of this dangerous possible side effect of Tecfidera. Attorney Tom Lamb discusses the FDA's warning in his recent article, "A Tecfidera Label Change Modifying Warnings About Progressive Multifocal Leukoencephalopathy (PML) Was Done In February 2016 With Little Notice."
The first three cases of Tecfidera-induced PML occurred among patients with prolonged severe lymphopenia (low lymphocyte count), but Kristina Fiore reports in her MedPage Today article that the most recent case occurred among "a patient with only moderate lymphopenia...raising new questions about the drug's safety" (emphasis added).
Of note, these initial cases "occurred in patients treated with dimethyl fumarate who had not previously received other drugs, such as [Tysabri] natalizumab, known to be associated with a risk for PML" according to "New EMA Advice on PML Prevention With Dimethyl Fumarate (Tecfidera) in MS."
Though the most recent case involved a patient who was previously treated with Tysabri, she stopped such treatment two months prior to starting Tecfidera, and was diagnosed with PML just shy of two years later, as discussed in this MedScape article. Additionally, Fiore states in her aforementioned article that "the company said that prior exposure wasn't considered a confounder in this case."
This goes to show that even though Tecfidera is typically regarded as one of the "safer" immunosuppressant agents, it still has the potential to cause dangerous adverse side effects.
As a precautionary measure, the European Medicines Agency encourages doctors to continuously monitor the lymphocyte counts of their patients, and check for the presence of JC virus infection before they consider prescribing Tecfidera.
We will continue to monitor the medical literature concerning the link between Tecfidera and PML, and report on any new cases of PML that arise due to Tecfidera treatment.
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