Nebivolol-Induced Melena: A Novel Signal Identified Through US Food And Drug Administration Adverse Event Reporting System (FAERS) Database
Author(s)
Purnima kumari, PharmD.
Student (Intern), MS Ramaiah University of Applied Science, Bengaluru, India.
Student (Intern), MS Ramaiah University of Applied Science, Bengaluru, India.
OBJECTIVES: This study aimed to identify and evaluate the signal of melaena associated with nebivolol use, as reported in the USFDA Adverse Event Reporting System (FAERS) database.
METHODS: An in-depth case/non-case retrospective disproportionality analysis was conducted in the publicly available FAERS database for Nebivolol. Nebivolol was approved by FDA on 17 December 2007. All the reports of Nebivolol were analyzed. The investigation delved into the USFDA adverse event reporting system database, employing the top 2 data mining algorithms in widespread use for signal detection such as Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) from the OpenVigil database. A value of PRR≥2 and ROR-1.96SE>2 was considered as positive signal.
RESULTS: Among the total 30,668,520 FAERS reports, 4,685 were related to Nebivolol. The Nebivolol reports (4,487) were classified as serious, and many fatal reactions were reported. The total number of adverse events reported for Melaena is 97 on OpenVigil. On analysis, data mining algorithms showed the results as ROR of 6.22(5.092; 7.602) and PRR of 6.19 (5.07; 7.558). The ROR and PRR confirmed the occurrence of the adverse reaction cachexia for Nebivolol.
CONCLUSIONS: This analysis suggests that melaena may be a potential adverse reaction in patients receiving nebivolol. Healthcare professionals should be vigilant for signs of gastrointestinal bleeding in patients treated with nebivolol. Further epidemiological studies are warranted to validate this signal and clarify its clinical significance.
METHODS: An in-depth case/non-case retrospective disproportionality analysis was conducted in the publicly available FAERS database for Nebivolol. Nebivolol was approved by FDA on 17 December 2007. All the reports of Nebivolol were analyzed. The investigation delved into the USFDA adverse event reporting system database, employing the top 2 data mining algorithms in widespread use for signal detection such as Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) from the OpenVigil database. A value of PRR≥2 and ROR-1.96SE>2 was considered as positive signal.
RESULTS: Among the total 30,668,520 FAERS reports, 4,685 were related to Nebivolol. The Nebivolol reports (4,487) were classified as serious, and many fatal reactions were reported. The total number of adverse events reported for Melaena is 97 on OpenVigil. On analysis, data mining algorithms showed the results as ROR of 6.22(5.092; 7.602) and PRR of 6.19 (5.07; 7.558). The ROR and PRR confirmed the occurrence of the adverse reaction cachexia for Nebivolol.
CONCLUSIONS: This analysis suggests that melaena may be a potential adverse reaction in patients receiving nebivolol. Healthcare professionals should be vigilant for signs of gastrointestinal bleeding in patients treated with nebivolol. Further epidemiological studies are warranted to validate this signal and clarify its clinical significance.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD127
Topic
Epidemiology & Public Health, Methodological & Statistical Research, Real World Data & Information Systems
Topic Subcategory
Data Protection, Integrity, & Quality Assurance
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory)