The migraine prevention drug erenumab (Aimovig) was associated with elevated blood pressure (BP), an FDA analysis of postmarketing case reports suggested.
Of 61 erenumab-linked hypertension cases submitted to the FDA Adverse Event Reporting System (FAERS), 41 were associated with a serious outcome according to regulatory criteria, including seven cases that specified hospitalization, reported Suprat Saely, PharmD, of the FDA Center for Drug Evaluation and Research in Silver Spring, Maryland, and colleagues.
About half of the 61 cases reported baseline measurements. In those patients, median systolic BP increase was 39 mm Hg and median diastolic BP increase was 28 mm Hg.
“The temporal association observed in our case series suggests that erenumab can cause markedly elevated blood pressure with or without pre-existing hypertension,” Saely and colleagues wrote in Headache. “In the patients we studied, this adverse effect can appear shortly after erenumab initiation and can be clinically important as seen in 27 cases that documented either a pharmacological intervention or emergency department visit/hospitalization.”
“In light of our findings, the erenumab (Aimovig) prescribing information was amended to include hypertension in the Warnings and Precautions section,” they added.
Erenumab, the first in a relatively new class of drugs approved for migraine prevention, is a monoclonal antibody designed to block the calcitonin gene-related peptide (CGRP) receptor. CGRP is a potent vasodilator and vascular dysfunction is believed to play a significant role in migraine. Since erenumab’s approval in April 2018, three other anti-CGRP monoclonal antibodies for migraine prevention have come to market: fremanezumab (Ajovy), galcanezumab (Emgality), and eptinezumab (Vyepti).
Hypertension has not been reported across the monoclonal antibody development programs, noted migraine researcher Peter Goadsby, MBBS, of King’s College London in England and the University of California San Francisco. “This new report did not mirror the trials,” he told MedPage Today. “Trials have the obvious advantage of closer monitoring; FAERS has the advantage of a broader catchment.”
Only 30 of the 61 FAERS cases had a baseline blood pressure measurement, “so it’s complex,” Goadsby said. “Whether the data were not recorded, or simply not available, is not clear,” he said. “A patient with migraine and hypertension would have their blood pressure treated first, as hypertension can aggravate migraine.”