BEVACIZUMAB INDUCED PULMONARY EMBOLISM- A DISPROPORTIONALITY ANALYSIS IN USFDA ADVERSE EVENT REPORTING SYSTEM DATABASE
Author(s)
Bellapu A1, K Viswam S2, Ravindra Reddy N3, Chacko S3, Sharma V4
1M.S. Ramaiah University of Applied Sciences, Bengaluru, KA, India, 2M.S. Ramaiah University of Applied Sciences, Bengalore, KA, India, 3M.S Ramaiah University of Applied Sciences, Bangalore, KA, India, 4M.S Ramaiah University of Applied Sciences, Hyderabad, AP, India
Presentation Documents
OBJECTIVES: Signal detection is one of the most advanced and emerging field in pharmacovigilance. It facilitates early adverse drug reaction detection. Bevacizumab is a VEGF inhibitor approved by the US Food and Drug Administration (FDA) in 2004 for the treatment of metastatic colorectal cancer. This study aims in the identification of pulmonary embolism associated with bevacizumab using disproportionality analysis of the FDA Adverse Event Reporting System (FAERS). METHODS: Data were obtained from the public release of data in FAERS. Case/non-case method was adopted for the analysis of association between bevacizumab use and pulmonary embolism. The data mining algorithm used for the analysis were Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR). A value of ROR-1.96SE>1, PRR≥2 were considered as positive signal. RESULTS: A total of 52,770 reports for Pulmonary embolism have been reported in the FDA database. Amongst which 1,264 reports were associated with bevacizumab. Pulmonary embolism ranked 25th among 900 bevacizumab associated adverse drug events. The mean age was 61.21 and female to male ratio was 1.01:1. A positive signal was obtained with ROR: 3.40 and PRR: 3.42. 394 death reports and the non-death serious reports included hospitalization, life-threatening, disability, and other serious events with 53, 36, 4 and 626 reports respectively. Linear regression analysis indicated there was no significant correlation between the PRR and time (R=0.045; p=0.876) and ROR and time (R=0.60; p=0.831). The Log Likelihood ratio for pulmonary embolism with bevacizumab was found to be 548.23 and the reporting ratio was 2.94 (Critical value-5.68). CONCLUSIONS: A positive signal was observed for bevacizumab associated pulmonary embolism, although a causal relation cannot be definitively proved. Health care professionals should be cautious about the possibility of serious adverse events associated with bevacizumab and should report to concerned regulatory authorities.
KEYWORDS: Bevacizumab, Pulmonary embolism
Conference/Value in Health Info
2019-11, ISPOR Europe 2019, Copenhagen, Denmark
Code
PRS65
Topic
Clinical Outcomes, Epidemiology & Public Health
Topic Subcategory
Clinical Outcomes Assessment, Public Health, Safety & Pharmacoepidemiology
Disease
Respiratory-Related Disorders, Systemic Disorders/Conditions