Silver Spring, MD—Based on a new analysis, prescribing information on a first-in-class migraine headache medication was altered by the FDA.

A brief communication in the journal Headache reports the findings of an analysis to identify and analyze postmarketing case reports of elevated blood pressure (BP) associated with erenumab use.

Erenumab, marketed under the brand name Aimovig, targets the calcitonin gene–related peptide receptor (CGRPR) for the prevention of migraine. It was the first of the group of CGRPR antagonists to be FDA approved in 2018. A a form of monoclonal antibody therapy in which antibodies are used to block the receptors for the protein CGRPR, understood to play a major role in starting migraines, it was the first of the group of CGRPR antagonists to be approved by the FDA in 2018.

The retrospective analysis reviewed 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. The FDA defines a case of elevated BP was defined as (a) an initiation of a pharmacologic 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.

Results indicate that 61 cases of elevated BP were identified; most, 86% were women, and the median age was 56 years. Of those, 41 were associated with a serious outcome per regulatory criteria, including seven that specified hospitalization, although no one died.

According to the FDA, 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. Overall, 44% of cases reported treatment for elevated BP, such as pharmacologic intervention or emergency department visit/hospitalization. The analysts said elevated BP occurred most frequently, 46% of cases, within a week of the first dose of erenumab. Of those, 31% reported a history of preexisting hypertension.

“This case series suggest an association between elevated BP and use of erenumab,” the authors write. “In light of our findings, the erenumab (Aimovig) prescribing information was amended to include hypertension in the Warnings and Precautions section.”

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.