| アブストラクト | OBJECTIVE: To identify and analyze adverse event reports of arterial hypertension (hereinafter referred as hypertension) associated with calcitonin gene-related peptide (CGRP) ligand (L) and receptor (R) blockers. BACKGROUND: CGRP is a potent peripheral and cerebral vasodilator and plays a key role in the pathogenesis of migraine. The US Food and Drug Administration (FDA) previously identified postmarketing case reports of hypertension associated with erenumab resulting in an amendment of the US Prescribing Information. However, at that time, no hypertension safety signal was apparent for other CGRP-L/R blockers. METHODS: In this retrospective pharmacovigilance case series, we reviewed case reports from the FDA Adverse Event Reporting System database and the medical literature through October 15, 2025, for hypertension associated with the use of any of the eight CGRP-L/R blockers approved and marketed in the United States, except for erenumab. A case of hypertension was defined as (1) the initiation of a pharmacological intervention or emergency department visit or hospitalization for emergent de novo or worsening of preexisting hypertension, OR (2) blood pressure (BP) measurement >/=140 mmHg systolic or >/=90 mmHg diastolic with or without baseline BP measurement reported. RESULTS: We identified a total of 106 cases of hypertension in FDA Adverse Event Reporting System and the medical literature with a probable or possible causal association with CGRP-L/R blocker use: 78 (74%) cases with CGRP-L monoclonal antibodies and 28 (26%) cases with the CGRP-R small molecules. Reporting of de novo hypertension was slightly more frequent than worsening of preexisting hypertension. The latency between CGRP-L/R blocker initiation and hypertension onset was </=30 days in two-thirds of the cases. In over one-third (40/106) of the cases, new antihypertensive treatment was initiated, or the dosage of preexisting antihypertensive treatment was increased. CGRP-L/R blocker discontinuation occurred in 76% (47/62) of the cases. CONCLUSION: Adverse event case reports provide reasonable evidence of a causal association between hypertension and CGRP-L/R blockers used for the preventive or acute treatment of migraine. In light of these findings, the US Prescribing Information of the entire CGRP-L/R blocker class now includes a description of the risk of hypertension in the Warnings and Precautions section. |
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| ジャーナル名 | Headache |
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| Pubmed追加日 | 2026/4/2 |
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| 投稿者 | Croteau, David; Tobenkin, Anne; Saely, Suprat; Chan, Vicky; Scripko, Patricia; Jawidzik, Laura; Fitter, Heather D; Lee, Paul R; Hughes, Alice; Phipps, Christine; Brinker, Allen |
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| 組織名 | Division of Pharmacovigilance, Office of Surveillance and Epidemiology, US Food &;Drug Administration, Silver Spring, MD, USA.;Division of Neurology, Office of Neuroscience, Office of New Drugs, US Food & |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41923443/ |
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