Expanding spectrum of opportunistic infections associated with dimethyl fumarate.

BACKGROUND

Only progressive multifocal leukoencephalopathy (PML) is currently described in the dimethyl fumarate (DMF) prescribing information.

OBJECTIVES

To describe opportunistic infections (OIs), other than PML, reported in association with DMF.

METHODS

The FDA Adverse Event Reporting System (FAERS) and medical literature were searched.

RESULTS

We retrieved 34 cases of serious OIs with a causal association with DMF, including 11 central nervous system (CNS) infections and 23 extra-CNS infections. Six OIs occurred with normal circulating absolute lymphocyte counts. The median latency from DMF initiation was 13 months and was variable.

CONCLUSION

DMF is associated with the development of OIs that require invasive diagnostic and/or therapeutic procedures. Patients should be monitored for OIs when treated with DMF regardless of circulating absolute lymphocyte counts.