Drug safety in multiple sclerosis: From reporting to signal detection and benefit-risk management

Abstract

Background: Pharmacovigilance (PV) rules emerged in the late 60s-early 70s. Since that time, the World Health Organization Center for International Drug Monitoring carries out the corresponding tasks. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system that generally starts in young adults between 20 and 40 years of age. Over the last 25 years, MS patients have benefited from the development of a plethora of disease modifying drugs (DMD). These changes in the therapeutic armamentarium have been associated with some serious adverse reactions challenging health authorities and neurologists involved in treatment and care for MS patients.

Methods: The present review aims to describe, for MS DMDs, how adverse drug reactions are reported during clinical trials and the post-marketing period and how important signal detection and benefit-risk management have been in this disease until now. Several examples are reported to illustrate the different steps of PV processes.

Conclusion: Improvement of the PV system procedures has led to significant progress in the detection of signals, allowing better assessment of the benefit-risk balance and the implementation of risk management plans for MS treatments. The involvement of neurologists is essential to improve knowledge on the benefit-risk balance of these drugs. In addition, adverse drug reactions reporting by persons with MS should be encouraged.

Keywords: ADR reporting; Benefit-risk assessment; Multiple sclerosis; Pharmacovigilance; Signal detection.