ArticleBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2024
Cardiovascular Adverse Drug Reactions of Anti-Calcitonin Gene-Related Peptide Monoclonal Antibodies for Migraine Prevention: An Analysis from the European Spontaneous Adverse Event Reporting System.
Article in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.
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Who cites it
12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.
- Post-marketing safety of CGRP monoclonal antibodies and gepants: A systematic review of spontaneous reporting system data.Headache · 2026Pooled it
- Effectiveness and safety of anti-CGRP monoclonal antibodies for migraine in patients over 65 years: a systematic review.Pain management · 2025Pooled it
- Erenumab for Chronic Cluster Headache: A Randomized Clinical Trial.JAMA network open · 2025Trial
- Ten tips for the diagnosis and management of fibromuscular dysplasia.Clinical kidney journal · 2026Review
- Safety Profile of Zavegepant in the Treatment of Acute Migraine: Insights from the FDA Adverse Event Monitoring System Database.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Identifying cardiac safety signals of disproportionate reporting for CGRP antagonists: evidence from the FDA Adverse Event Reporting System.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Calcitonin Gene-Related Peptide Inhibitors and Cardiovascular Events in Patients With Migraine: A Retrospective, Observational Cohort Study.Neurology · 2026Observational
- Response to the Letter to the Editor: "Reaffirming Caution-The Unacceptable Vasoconstrictive Risk of CGRP-Related Therapies in Moyamoya Angiopathy".European journal of neurology · 2026Article
- Letter to the Editor: Reaffirming Caution-The Unacceptable Vasoconstrictive Risk of CGRP-Related Therapies in Moyamoya Angiopathy.European journal of neurology · 2026Article
- Fremanezumab for the treatment of migraine.Pain management · 2025Review
- CGRP-Targeted Migraine Therapies in Patients With Vascular Risk Factors or Stroke: A Review.Neurology · 2025Review
- Cardiovascular Safety of Anti-CGRP Monoclonal Antibodies in Older Adults or Adults With Disability With Migraine.JAMA neurology · 2025Article
Corrections and comments
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Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionAnti-calcitonin gene-related peptide monoclonal antibodies (anti-CGRP-mAbs) have recently been approved for the prevention of migraine, and their safety profile is not fully characterized.
objectiveThe aim of this study was to evaluate the adverse drug reactions (ADRs) of anti-CGRP-mAbs through the analysis of individual case safety reports (ICSRs) collected in the EudraVigilance (EV) database, with a specific focus on cardiovascular (CV) ADRs.
methodsData on ICSRs recorded between July 2018 and December 2022 in the EV database, involving one of the anti-CGRP-mAbs for migraine prevention-erenumab (ERE), galcanezumab (GMB), fremanezumab (FMB), and eptinezumab (EPT)-were included in the analysis. All ICSRs reporting at least one CV ADR, as identified within the MedDRA
resultsA total of 9441 ICSRs were recorded in the EV database from 2018 to 2022, of which more than half were related to ERE (58.9%), followed by GMB (21.4%), FMB (19.0%), and EPT (0.7%). CV ICSRs accounted for 1205 cases (12.8%), with a total of 1599 CV ADRs. The CV ICSRs were mainly related to female patients (82.6%) aged 18-64 years (73.4%). Of the reported CV ADRs, 67.5% were considered serious. Among the total number of ICSRs related to each anti-CGRP-mAb, those associated with FMB had a higher percentage of CV ADRs (n = 253; 14.1%), followed by ERE (n = 707; 12.7%), EPT (n = 8; 12.7%), and GMB (n = 237; 11.7%). A higher frequency of reporting hypertension was shown for ERE (ROR = 1.45; 95% CI = 1.14-1.85). Pallor was mainly observed with FMB (5.00; 1.68-14.89), as well as deep vein thrombosis (3.86; 1.57-9.51), hot flush (2.16; 1.43-3.25), and palpitations (1.48; 1.05-2.08). Atrial fibrillation (2.36; 1.02-5.46) and myocardial infarction (2.21; 1.37-3.58) were mostly reported for GMB.
conclusionThe analysis of anti-CGRP-related CV ADRs was consistent with the information reported in the literature. However, hypertension with ERE, atrial fibrillation and myocardial infarction with GMB, as well as pallor, deep vein thrombosis, hot flush, and palpitations with FMB were not reported in the Summary of Product Characteristics (SmPCs). Considering this, more post-marketing analyses are needed to improve knowledge on the CV safety profiles of anti-CGRP-mAbs, especially for the last approved medication, EPT.
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