Many side effects of calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) have emerged after initial clinical trials predicted a much milder safety profile. Lawrence Robbins, MD, Robbins Headache Clinic, Riverwoods, IL, shares different proposals on what can be done to avoid adverse effects underestimation during clinical trials. The package inserts often do not reflect the reality of the adverse effects profile; the FDA should overhaul the guidelines as to how adverse events are acquired in studies. Distribution of post-approval articles about adverse effects can be a possible strategy to increase neurologists’ awareness. This interview was conducted during the virtual 2021 World Congress on Controversies in Neurology (CONy).
Dr Robbins is a speaker for Amgen, Teva, Lundbeck, Biohaven and Abbvie.