Why carry out this study?

Although randomized controlled trials have demonstrated the safety of treatment with the calcitonin gene-related peptide pathway–targeted monoclonal antibodies (CGRP mAbs) erenumab, fremanezumab, and galcanezumab for the preventive treatment of migraine, post-marketing data are valuable for understanding the safety of these medications in a real-world setting in broad and diverse populations of patients not necessarily represented in a clinical trial setting.

In this study, we retrospectively evaluated data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to analyze real-world adverse event (AE) reporting for erenumab, fremanezumab, and galcanezumab for the 6-month periods following their respective FDA approvals.

What was learned from this study?

In this retrospective analysis, AEs of migraine/headache, drug ineffective, or injection-site reactions were commonly reported for all three products, while constipation ranked second for erenumab but did not make the top ten AEs for fremanezumab or galcanezumab.

The frequency of serious outcomes was low, with ≤ 2% of AEs categorized as serious across the three CGRP mAbs assessed; cardiovascular events did not rank in the top ten AEs for any of the three products.

These findings may inform health care providers’ decision making at the time of drug prescription for their patients.