Abstract
We would like to thank Dr Constant dit Beaufils et al. (1) for their interest in our recent study (2) and for their constructive feedback. We welcome the opportunity to further explore the field of RCVS drug-induced diseases.
We were particularly interested in two key points raised in their letter. First, they highlight the distinction between precipitating and predisposing drugs. Retrospective cohorts have already suggest that antidepressant may predispose individuals to development of reversible cerebral vasoconstriction syndrome (RCVS). The triptans and decongestant drugs would be the precipitating drugs. We believe our descriptive study provides supporting evidence. Antidepressants were often combined with triptans or nasal decongestants. This suggests that the consumption of these latter drugs in patients on long-term selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI) therapy may constitute an additional risk factor.
Secondly, the potential harm of drug re-exposure in RCVS is a critical concern. Unfortunately, our study lacked sufficient data to address this issue directly. While a few cases were reported with reintroduction, outcomes were not documented. This underscores the importance of reporting adverse drug reactions to pharmacovigilance systems to gather real-world safety data and improve drug safety.
To foster a deeper understanding of antidepressants and RCVS, a national pharmacovigilance survey was conducted in 2022 (3). This unique European tool facilitates a collaborative, clinical and pharmacological discussion, incorporating regulatory perspectives (4). This survey identified 24 cases. Despite the limited number of cases, the available literature and pharmacovigilance data strongly suggest a potential risk of RCVS with all SSRIs and SNRIs. It is noteworthy that RCVS is only mentioned as an adverse drug reaction in the Summary of Product Characteristics (SmPC) for sertraline. Discussions surrounding this pharmacovigilance survey highlighted the challenges of diagnosis, the absence of cases with positive reintroduction and the significant variability in time to onset. The need for further research to better characterize this risk and its underlying mechanisms was emphasized. Consequently, the RCVS signal was raised at the European level by the Pharmacovigilance Risk Assessment Committee for paroxetine, but has not yet been formally adopted.
The French pharmacovigilance network remains vigilant regarding this signal. However, raising awareness through SmPC updates requires action from health authorities, which has not yet materialized. Therefore, it is imperative that clinicians actively report suspected cases of drug-induced RCVS.
