Abstract
I am writing to address the concerns raised regarding the incidence of sexual dysfunction as an adverse event associated with medications targeting calcitonin gene-related peptide (CGRP) signaling for migraine treatment. Recent case reports published in Cephalalgia by Al-Hassany et al. (1) suggest a potential link between these medications and sexual dysfunction. However, any adverse event, especially one impacting sexual health, necessitates thorough investigation.
To further investigate the incidence of sexual dysfunction, data were extracted from the US Food and Drug Administration Adverse Event Reporting System (FAERS). FAERS is a valuable resource for post-marketing safety surveillance, collecting information on adverse events and medication errors reported by healthcare professionals, consumers and manufacturers. An analysis of FAERS data revealed a low number of sexual dysfunction reports among available reported adverse events of CGRP inhibitors (0.01306%; 95% confidence interval = 0.01232–0.01380%) (Table 1) (2). Importantly, the reported cases were distributed across both sexes, suggesting that this adverse event is neither common, nor sex-specific. Despite clinicians generally under-reporting to FAERS (3), the data it provides offer a broader post-marketing perspective that complements other real-world evidence and clinical trial findings.
Number of reports of sexual dysfunction as an adverse event of medications targeting the calcitonin gene-related pathway in the US Food and Drug Administration Adverse Event Reporting System.
The pooled proportion of cases reporting sexual dysfunction was 12/91860 (0.01306%; 95% confidence interval = 0.01232%–0.01380%) of any reported adverse events. Data were extracted from the US Food and Drug Administration Adverse Event Reporting System (FAERS) on 7 June 2024. The FAERS data set was last updated 31 March 2024 on the date of extraction.
It is essential to acknowledge that sexual dysfunction is a multifactorial condition influenced by various psychological, physiological and pharmacological factors. Individuals experiencing migraine attacks often have comorbid conditions (4), such as depression and anxiety, which themselves can contribute to sexual dysfunction. Therefore, clinicians should be careful of attributing sexual dysfunction solely to CGRP inhibitors without considering these confounding factors based on the limited available evidence.
In conclusion, the evidence indicates that sexual dysfunction as an adverse event of CGRP-targeting medications is rare and not sex-specific. Healthcare providers should be reassured by these findings, although continued vigilance in monitoring and reporting adverse events remains essential. Patients should be encouraged to discuss any concerns with their healthcare providers to ensure a comprehensive approach to their treatment and overall well-being.
Footnotes
Funding
The author received no financial support for the research, authorship and/or publication of this article.
Declaration of conflicting interests
The author declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Thien Phu Do reports personal fees from Teva, outside of the submitted work.
Author contributions
TPD contributed to conception and design, acquisition of data, interpretation of data for the work. TPD wrote the first draft of the manuscript, critically revised important intellectual content and approved the final version of the manuscript submitted for publication.
