Division of Pharmacovigilance I, Office of Surveillance and Epidemiology, FDA Center for Drug Evaluation and Research, Silver Spring, MD, USA.
Division of Neurology II, Office of Neurology, Office of New Drugs, FDA Center for Drug Evaluation and Research, Silver Spring, MD, USA.
Headache. 2021 Jan;61(1):202-208. doi: 10.1111/head.14051. Epub 2021 Jan 10.
To identify and analyze postmarketing case reports of elevated blood pressure (BP) associated with erenumab use.
A retrospective analysis of postmarketing (spontaneous) case reports of erenumab-associated elevated BP submitted to the FDA Adverse Event Reporting System from May 17, 2018 through April 30, 2020. A case of elevated BP was defined as (a) an initiation of a pharmacological intervention or emergency department visit or hospitalization for emergent de novo or worsening of preexisting hypertension, or (b) BP measurement of ≥140 mm Hg systolic or ≥90 mm Hg diastolic with or without baseline BP measurement reported. Reports of elevated BP associated with erenumab use were analyzed for baseline and demographic information, latency, drug-event causal association, and clinical outcome.
Sixty-one cases of elevated BP were identified, 86% (49/57) were women and the median age was 56 [range 24-88] years. Forty-one cases were associated with a serious outcome per regulatory criteria, including seven that specified hospitalization. No case reported an outcome of death. The median systolic BP increase was 39 (interquartile range (IQR) 32, 59) mm Hg and median diastolic BP increase was 28 (IQR 18, 41) mm Hg. A total of 27/61 (44%) cases reported treatment for elevated BP (i.e., pharmacologic intervention or emergency department visit/hospitalization). Elevated BP occurred most frequently (28/61, 46%) within a week of the first dose of erenumab. Nineteen cases (19/61, 31%) reported a history of preexisting hypertension.
This case series suggest an association between elevated BP and use of erenumab. In light of our findings, the erenumab (Aimovig) prescribing information was amended to include hypertension in the Warnings and Precautions section.
识别和分析与依瑞奈单抗使用相关的上市后血压升高（BP）的病例报告。
对 2018 年 5 月 17 日至 2020 年 4 月 30 日期间向美国食品药品监督管理局不良事件报告系统提交的与依瑞奈单抗相关的血压升高上市后（自发）病例报告进行回顾性分析。血压升高定义为：（a）开始进行药物干预或因新发或原有高血压恶化而急诊就诊或住院，或（b）收缩压≥140mmHg 或舒张压≥90mmHg，无论是否有基线血压测量值报告。对与依瑞奈单抗使用相关的血压升高报告进行了基线和人口统计学信息、潜伏期、药物事件因果关系和临床结局的分析。
共发现 61 例血压升高病例，86%（49/57）为女性，中位年龄为 56[范围 24-88]岁。根据监管标准，41 例与严重结局相关，包括 7 例指定住院。无死亡病例报告。收缩压中位数升高 39（四分位距[IQR] 32，59）mmHg，舒张压中位数升高 28（IQR 18，41）mmHg。共有 27/61（44%）例报告了血压升高的治疗（即药物干预或急诊就诊/住院）。依瑞奈单抗首次给药后一周内，血压升高最常见（28/61，46%）。19 例（19/61，31%）报告有原有高血压病史。
本病例系列提示血压升高与依瑞奈单抗的使用之间存在关联。鉴于我们的发现，依瑞奈单抗（Aimovig）的说明书在警告和注意事项部分增加了高血压。
