Data mining and analysis of febuxostat-induced cardiac ADR signals / 中国药房

ABSTRACT

OBJE CTIVE To mine and analyze t he cardiac adverse drug reaction （ADR）signals induced by febuxostat in post-marketing experience ，and to provide reference for rational drug use in clinic. METHODS Reporting odds ratio （ROR） method was used to mine the ADR signals induced by febuxostat from the FDA Adverse Event Reporting System during the first quarter of 2009 to the fourth quarter of 2020；the information of cardiac disease signals was counted and analyzed. RESULTS A total of 209 ADR signals were detected in 8 282 adverse drug event （ADE）reports with febuxostat as the primary suspected drug ， involving 27 cardiac signals and 754 ADE reports. The most reported signals were symptoms （262 reports），including dizziness ， oedema peripheral，chest pain ，palpitations and gravitational oedema and so on ，followed by coronary atherosclerotic heart disease signal，heart failure signal ，arrhythmia signal ，sudden cardiac death signal （233，157，90，12 reports，respectively）. More than half of the signals were mentioned in the drug instructions ，while the unmentioned signals were mainly kinds of cardiac failure ， arrhythmia and extrasystoles ，etc. The patients with cardiac ADEs who received febuxostat were more male than female ，and the age was 60 and over ；the drug dosage was mostly 40 mg/d or 80 mg/d as recommended in the drug instructions ，and cardiac ADEs mostly occurred within 1 month of medication. CONCLUSIONS Routine attention should be paid to the cardiac safety of febuxostat during medication ，further evaluation and validation of febuxostat-induced cardiac ADR signals are still needed.