Background: Signal strength for any drug-event combination can be determined using
disproportionality analysis. Vemurafenib is a BRAF inhibitor approved by the US Food and Drug
Administration (FDA) in 2011 for the treatment of metastatic melanoma. This study aims to identify
the signal strength of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) associated
with vemurafenib using disproportionality analysis in FDA database of Adverse Event Reporting
Methods: Data were obtained from the public release of data in FAERS. The case/non-case method
was adopted for the analysis of the association between vemurafenib use and DRESS. The data
mining algorithm used for the analysis was the Reporting Odds Ratio (ROR) and Proportional
Reporting Ratio (PRR). A value of ROR-1.96SE>1, PRR≥2 was considered as positive signal
Results: A total of 7,171 reports for DRESS have been reported in the FDA database. Amongst which,
125 reports were associated with vemurafenib. A cumulative ROR of 17.72 (95% CI 14.83; 21.18)
and PRR of 17.46 (95% CI 14.65; 20.81) were observed. Combination treatment of vemurafenib
with cobimetinib had a higher number of reports (100) with ROR of 103.42 (84.13- 127.14) and
PRR of 94.52 (78.26- 114.15). Four deaths were reported and the non-death serious reports included
hospitalization, life-threatening, disability, and other serious events with 61, 11, 2 and 39 reports,
Conclusion: Positive signal strength was observed for vemurafenib associated DRESS. The signal
strength was higher for vemurafenib in combination with cobimetinib than vemurafenib alone.
Health care professionals should be cautious about encountering serious adverse events and should
report such events to the regulatory authorities.
Keywords: Vemurafenib, DRESS, Disproportionality analysis, FAERS, vemurafenib, lymphadenopathy.Vemurafenib, DRESS, Disproportionality analysis, FAERS, vemurafenib, lymphadenopathy.Vemurafenib, DRESS, Disproportionality analysis, FAERS, vemurafenib, lymphadenopathy.
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