ArticleThe journal of headache and pain2022
Calcitonin gene-related peptide-targeting drugs and Raynaud's phenomenon: a real-world potential safety signal from the WHO pharmacovigilance database.
Article in The journal of headache and pain, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.
What it found
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Who cites it
23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 41 citations in OpenAlex.
- Post-marketing safety of CGRP monoclonal antibodies and gepants: A systematic review of spontaneous reporting system data.Headache · 2026Pooled it
- Pooled it
- Drug-Induced Raynaud's Phenomenon and Underlying Mechanism: A Disproportionality Analysis From the World Health Organization Pharmacovigilance Database.Arthritis & rheumatology (Hoboken, N.J.) · 2026Article
- Calcitonin gene-related peptide antagonists in Raynaud's phenomenon: a disproportionality study based on real data and drug-gene network analysis.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
- CGRP and Migraine: Real-World Insights and Future Therapeutic Directions.Annual review of medicine · 2026Review
- Cardiovascular adverse event reporting profile of tirzepatide: a real-world pharmacovigilance analysis of heart failure, arrhythmias, and ischemic events.Frontiers in pharmacology · 2026Article
- A comprehensive study on drug-related Raynaud's phenomenon based on the FDA adverse event reporting system.Scientific reports · 2025Article
- Expert consensus on gepants for acute and preventive treatment of migraine in Thailand.The journal of headache and pain · 2025Review
- Disproportionality analysis of Raynaud's phenomenon associated with calcitonin gene-related peptide inhibitors using the Food and Drug Administration adverse event reporting system.Scientific reports · 2025Article
- Cardiovascular Safety of Anti-CGRP Monoclonal Antibodies in Older Adults or Adults With Disability With Migraine.JAMA neurology · 2025Article
- Hallmarks of primary headache: part 1 - migraine.The journal of headache and pain · 2024Review
- Post-marketing safety concerns with rimegepant based on a pharmacovigilance study.The journal of headache and pain · 2024Article
- Migraine Management in Medically Complex Patients: a Narrative Review.Current neurology and neuroscience reports · 2024Review
- Managing Cluster Headache in Patients with Medical, Psychiatric, and Surgical Comorbidities.Current neurology and neuroscience reports · 2024Review
- 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.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024Article
- Mode and site of action of therapies targeting CGRP signaling.The journal of headache and pain · 2023Review
- A Brief Review of Gepants.Current pain and headache reports · 2023Review
- The Neuropsychiatric Safety Profile of Lasmiditan: A Comparative Disproportionality Analysis with Triptans.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2023Article
- Ten open questions in migraine prophylaxis with monoclonal antibodies blocking the calcitonin-gene related peptide pathway: a narrative review.The journal of headache and pain · 2023Review
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMigraine is responsible for significant disability and societal burden. Recently, drugs targeting the calcitonin gene-related peptide (CGRP) pathway raised new hopes. CGRP, a potent vasodilator, plays a key role in the pathogenesis of migraine attacks. The deficiency of CGRP is involved in Raynaud's phenomenon, which consists of abnormal vasoconstriction of the digits. We aimed to assess the potential association of Raynaud's phenomenon with CGRP-targeting drugs, analyzing real-world data from the World Health Organization (VigiBase®).
methodsWe queried all reports of Raynaud's phenomenon involving a CGRP-targeting drug. We sought disproportionate reporting of Raynaud's phenomenon with these drugs. For this purpose, we relied on the calculation of the Information Component (IC). A positive lower end of the 95% confidence interval (CI) of the IC defines a statistically significant association. As migraine patients are prone to Raynaud's phenomenon, we also calculated the IC of Raynaud's phenomenon with CGRP-targeting drugs compared to 5HT1
resultsOverall, 99 reports of Raynaud's phenomenon involving CGRP-targeting drugs have been yielded in VigiBase®. The most reported CGRP-targeting drug was erenumab, with 56 reports (56.6%). The median time to onset was 84 days. No fatality was notified, but one patient suffered from gangrene and extremity necrosis. As a whole, CGRP-targeting drugs were significantly associated with Raynaud's phenomenon, with an IC of 3.3 (95%CI: 3.0-3.5). There was a disproportionate reporting of Raynaud's phenomenon with CGRP-targeting drugs compared to triptans (IC 0.4; 95%CI: 0.1-0.6) and to beta-blockers (IC 0.5; 95%CI: 0.2-0.7) as well.
conclusionsThere is a significant disproportionality signal of Raynaud's phenomenon with CGRP-targeting. This signal stands out when CGRP-targeting drugs are compared to other drugs used in patients with migraine. This study is limited by missing data in pharmacovigilance reports. CGRP-targeting drugs may be subject to Weber effect and reporting bias. Nonetheless, CGRP blockade might be the last straw that disrupts the physiological balance of vascular response in patients at-risk of Raynaud's phenomenon. Pending further data regarding vascular safety of CGRP-targeting drugs, caution is warranted in these patients.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.