ISSUE1568
The FDA has approved changes to the labeling of erenumab-aooe (Aimovig)1, a once-monthly, subcutaneously injected calcitonin gene-related peptide (CGRP) blocker approved in 2018 for prevention of migraine. The new label contains a warning about hypersensitivity reactions, including rash, angioedema, and anaphylaxis, that have been reported with post-marketing use of the drug.
According to the label, most of these reactions were not serious and occurred within hours after receiving the drug, but some occurred more than one week after administration. Because these reactions are voluntarily reported, it is not possible to determine the actual incidence or establish causality. Hypersensitivity reactions, including rash, urticaria, and dyspnea, were reported during pre-approval clinical trials of fremanezumab-vfrm (Ajovy) and galcanezumab-gnlm (Emgality), the other FDA-approved CGRP blockers.2 Because of the long half-lives of these drugs, hypersensitivity reactions may be prolonged.