Heart & lung : the journal of critical care · 2026
Disproportionality analysis of cardiovascular adverse events reported to the FDA adverse event monitoring system with monoclonal antibodies targeting type 2 inflammation.
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Akbaş Melike Nur, Aksoyalp Zinnet Şevval
Аннотация
BACKGROUND: Type 2 inflammation leads to changes in the airways pathophysiology and several monoclonal antibodies targeting type 2 inflammation have been developed for allergic and eosinophilic diseases. However, long-term safety data for these medications are limited. Among the medications, only omalizumab has a safety warning for potential serious cardiovascular and cerebrovascular adverse events (AEs).
OBJECTIVE: The aim was to analyse the disproportionality of cardiovascular AEs reported to the FDA Adverse Event Monitoring System (AEMS) database with these medications.
METHODS: AEs related to "palpitations", "myocardial infarction", "tachycardia", "atrial fibrillation", "cardiac failure", "hypertension", "flushing", "hypotension", "haemorrhage", and "thrombosis" were collected in the AEMS database during 2022-2025. AE cases reported with "omalizumab", "mepolizumab", "benralizumab", "reslizumab", "dupilumab", and "tezepelumab" as the solely primary suspected medication were included. The following ratios were calculated: reporting odds ratio (ROR), proportional reporting ratio (PRR), and information component (IC).
RESULTS: The highest number of selected cardiac and vascular disorder AEs cases was reported with dupilumab (n = 3636), and the lowest number was reported with reslizumab (n = 52). The majority of selected AEs reported with monoconal antibodies other than dupilumab are serious. Tezepelumab was revealed to have the highest number of AE signals, whereas signal for haemorrhage was detected with dupilumab in the patients with asthma. The primary AEs signals identified with these medications are myocardial infarction, hypertension, flushing, and thrombosis.
CONCLUSIONS: Post-marketing data are valuable for determining the long-term safety of medications, and further studies confirming the cardiovascular AE signals identified in this study may yield insights into the cardiovascular safety of these monoclonal antibodies.
OBJECTIVE: The aim was to analyse the disproportionality of cardiovascular AEs reported to the FDA Adverse Event Monitoring System (AEMS) database with these medications.
METHODS: AEs related to "palpitations", "myocardial infarction", "tachycardia", "atrial fibrillation", "cardiac failure", "hypertension", "flushing", "hypotension", "haemorrhage", and "thrombosis" were collected in the AEMS database during 2022-2025. AE cases reported with "omalizumab", "mepolizumab", "benralizumab", "reslizumab", "dupilumab", and "tezepelumab" as the solely primary suspected medication were included. The following ratios were calculated: reporting odds ratio (ROR), proportional reporting ratio (PRR), and information component (IC).
RESULTS: The highest number of selected cardiac and vascular disorder AEs cases was reported with dupilumab (n = 3636), and the lowest number was reported with reslizumab (n = 52). The majority of selected AEs reported with monoconal antibodies other than dupilumab are serious. Tezepelumab was revealed to have the highest number of AE signals, whereas signal for haemorrhage was detected with dupilumab in the patients with asthma. The primary AEs signals identified with these medications are myocardial infarction, hypertension, flushing, and thrombosis.
CONCLUSIONS: Post-marketing data are valuable for determining the long-term safety of medications, and further studies confirming the cardiovascular AE signals identified in this study may yield insights into the cardiovascular safety of these monoclonal antibodies.