Safety of the newer disease-modifying agents for multiple sclerosis: disproportionality analysis in the FDA Adverse Events Reporting System database.

  • Vasiliki Nikolopoulou
  • Spyridon Siafis
  • Antonios Milonas
  • Dimitrios Kouvelas
  • Georgios Papazisis


Purpose: Aim of the present study was to identify potential safety signals for the six newer disease-modifying therapies
(DMTs) for multiple sclerosis using the FDA Adverse Events Reporting System (FAERS) database.
Methods: A case/non-case study was conducted with data from spontaneous reports submitted in FAERS between 2004 and 2018, using the OpenVigil2.1-MedDRA. Daclizumab, natalizumab integrin, alemtuzumab dimethyl fumarate, fingolimod, teriflunomide were examined. Adverse events were selected by the Summary Product Characteristics of the products, including all frequency levels. The reporting odds ratio (ROR) was used to express the association between DMTs and reporting adverse events.
Results: Currently approved DMTs share some common side effects such as increased risk for infections (especially progressive multifocal leukoencephalopathy and herpes virus infections), risk for neoplasms (basal and squamous cell carcinoma, kaposi's sarcoma) and blood disorders (lymphopenia, leukopenia, pure red cell aplasia) which were confirmed by our analysis.
Conclusion: This disproportionality analysis strengthens the already knowledge about the safety of DMTs for multiple sclerosis and emerges some new potential safety signals.

General article