There seems to have been more Tecfidera – progressive multifocal leukoencephalopathy (PML) cases reported in the past year or so. And it seems that lymphonpenia possibly induced by Tecfidera might have a role to play in those additional PML cases.
Tecfidera is a drug used to treat relapsing forms of multiple sclerosis (MS).
There is a February 29, 2016 FDA letter to Biogen Idec about a revision to the prescribing information for Tecfidera (dimethyl fumarate) having to do with progressive multifocal leukoencephalopathy (PML).
But that FDA letter does not inform one further about the new drug safety information for Tecfidera concerning progressive multifocal leukoencephalopathy (PML). To see what is new, one must read Section 5.2 of the current version of the Tecfidera label (Revised: 2/2016), where an added paragraph suggests two developments. The first is that there seems to have been more Tecfidera – PML cases reported in the past year or so. And the second is that lymphonpenia possibly induced by Tecfidera might have a role to play in those additional PML cases. Here is the added paragraph, short but significant, it seems:
[Progressive multifocal leukoencephalopathy (PML)] has also occurred in the postmarketing setting in the presence of lymphopenia (<0.8×109/L) persisting for more than 6 months. While the role of lymphopenia in these cases is uncertain, the majority of cases occurred in patients with lymphocyte counts <0.5x 109/L.
This February 2016 Tecfidera label change about PML can be compared to December 2014 FDA-approved version of the Tecfidera drug label, when information about the apparent PML side effect was first added. And that earlier Tecfidera label change seems to have been based on this document, “FDA Drug Safety Communication: FDA warns about case of rare brain infection PML with MS drug Tecfidera (dimethyl fumarate)”, issued November 25, 2014, from which we took this excerpt:
The U.S. Food and Drug Administration (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 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. This is the only confirmed case of this rare and serious brain infection reported in patients taking Tecfidera.
Finally, in the newly added paragraph found at “5.2 Progressive Multifocal Leukoencephalopathy” of the current Tecfidera label (Revised: 2/2016), there is this statement: “While the role of lymphopenia in these cases is uncertain, the majority of cases occurred in patients with lymphocyte counts <0.5x 109/L.”
We will continue to monitor the safety profile of the MS drug Tecfidera, especially as regards case reports of progressive multifocal leukoencephalopathy (PML).
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