First PML Case Reported with Dimethyl Fumarate Monotherapy for MS

Implications for patients with multiple sclerosis

Dimethyl fumarate (Tecfidera) is approved as a disease-modifying treatment for multiple sclerosis (MS) and is one of several new oral therapy options for MS (NEJM JW Neurol Oct 30 2012). Now, the FDA has announced a first case of progressive multifocal leukoencephalopathy (PML) in a patient taking dimethyl fumarate.

According to FDA reports, the female patient took dimethyl fumarate as monotherapy for MS for 4-plus years and had sustained lymphopenia. Lymphopenia is a known potential adverse effect of dimethyl fumarate. The FDA now advises clinicians to be alert to PML as a possible adverse effect with this therapy and to stop therapy if PML is suspected. The U.S. drug label for dimethyl fumarate advises that a complete blood count with diff…

Reviewing Author

Jeffrey M. Gelfand, MD, MAS

Disclosures

12/1/14I recently attended a trial investigator meeting as a sub-investigator for a clinical trial sponsored by Medimmune.

Jeffrey M. Gelfand, MD, MAS

Disclosures

12/1/14I recently attended a trial investigator meeting as a sub-investigator for a clinical trial sponsored by Medimmune.

First PML Case Reported with Dimethyl Fumarate Monotherapy for MS

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Reviewing Author