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Post-marketing data on CGRP inhibitors show paucity of data and additional risks from chronic biologic use

Post-marketing data on CGRP inhibitors show paucity of data and additional risks from chronic…
Photo by National Institute of Allergy and Infectious Diseases / Unsplash
Key Takeaway
Note paucity of data and chronic use risks for post-marketing CGRP inhibitor migraine therapies.

This narrative review focuses on monoclonal antibodies and Calcitonin Gene-Related Peptide (CGRP) inhibitors used to treat migraine. The publication is a review rather than a primary trial, and it addresses the post-marketing phase of these medications. The authors synthesize the current state of knowledge by pointing out a paucity of data available for these agents. They specifically mention the limitations of pre-marketing experience as a significant gap in understanding these therapies. The review also discusses additional risks associated with the intrinsic characteristics of biologic compounds in general. Furthermore, the authors emphasize the issue of chronic use of most of these drugs as a concern. The text does not report specific adverse events, serious adverse events, discontinuations, or tolerability rates because these details were not reported in the source. The review acknowledges that active pharmacovigilance carried out during the post-marketing phase aims to fill gaps by using continuous and pre-organized processes to fully identify the number of adverse events. This ongoing surveillance is intended to address the current lack of comprehensive safety information. The practice relevance is framed around the need for continued monitoring rather than established efficacy or safety profiles. Clinicians should be aware that the evidence base remains incomplete for these specific migraine treatments.

Study Details

Study typeSystematic review
EvidenceLevel 1
PublishedMay 2026
View Original Abstract ↓
Pharmacovigilance practices are essential for the rational use of medicines; this is even more true in the field of biologics. An ideal pharmacovigilance activity should cover all life phases of a drug to obtain more information on efficacy and safety by overcoming the limitations of pre-marketing studies. Active pharmacovigilance carried out during the post-marketing phase aims to fill these gaps by using continuous and pre-organized processes to fully identify the number of adverse events. In recent years, the number of biologic drugs approved by the Food and Drug Administration (FDA) has increased greatly. In the last decade, there has been a growing interest in identifying monoclonal antibodies against Calcitonin Gene-Related Peptide (CGRP) for treating migraines. However, pharmacovigilance on these biologics suffers from a paucity of data, and the limitations of pre-marketing experience, the additional risks associated with the intrinsic characteristics of biologic compounds, and the chronic use of most of these drugs make intensive and continuous pharmacovigilance activity necessary. This review aims to bring together all data on the efficacy and safety of biologics used to treat migraine. Both pre-marketing clinical trials and real-world post-marketing studies will be examined to provide a comprehensive overview of the data in the literature.
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