Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Jan;61(1):202-208.
doi: 10.1111/head.14051. Epub 2021 Jan 10.

Hypertension: A new safety risk for patients treated with erenumab

Suprat Saely  1 , David Croteau  1 , Laura Jawidzik  2 , Allen Brinker  1 , Cindy Kortepeter  1
Affiliations

Hypertension: A new safety risk for patients treated with erenumab

Suprat Saely et al. Headache. 2021 Jan.

Abstract

Objective: To identify and analyze postmarketing case reports of elevated blood pressure (BP) associated with erenumab use.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: Aimovig; blood pressure; erenumab; hypertension; migraine.

PubMed Disclaimer

Comment in

References

REFERENCES

    1. Amgen, Inc. Aimovig (Erenumab-aooe) Injection Prescribing Information. Thousand Oaks, CA; 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761077s007lbl.pdf. Accessed June 25, 2020.
    1. Jain S, Yuan H, Spare N, Silberstein SD. Erenumab in the treatment of migraine. Pain Manag. 2018;8(6):415-426.
    1. Deng PY, Li YJ. Calcitonin gene-related peptide and hypertension. Peptides. 2005;26(9):1676-1685.
    1. de Hoon J, Van Hecken A, Vandermeulen C, et al. Phase I, randomized, double-blind, placebo-controlled, single-dose, and multiple-dose studies of erenumab in healthy subjects and patients with migraine. Clin Pharmacol Ther. 2018;103(5):815-825.
    1. Jawidzik L. U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Aimovig/Erenumab Clinical Review: BLA 761077; 2018. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761077Orig1s000M.... Accessed July 6, 2020.

Substances

LinkOut - more resources