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Utilization patterns of Antihyperuricemic Agents Following Safety Announcement on Allopurinol and Benzbromarone by Taiwan Food and Drug Administration
Author(s) -
Cheng ChingLan,
Chao PiHuei,
Hsu Jason ChihSheng,
Weng Maggie MengYu,
On Angela W.F.,
Yang YeaHuei Kao
Publication year - 2014
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.3550
Subject(s) - benzbromarone , medicine , allopurinol , probenecid , sulfinpyrazone , pharmacoepidemiology , gout , generic drug , food and drug administration , drug , emergency medicine , environmental health , pharmacology , medical prescription , hyperuricemia , uric acid , platelet
Objective The purpose of this study is to evaluate the utilization of four approved antihyperuricemic agents in Taiwan before and after two safety announcements rescinded an indication for allopurinol and added a warning on benzbromarone‐induced hepatotoxicity in the year 2005. Methods An interrupted time series design and segmented regression models were used to examine impacts of the safety announcements on the utilization of allopurinol, benzbromarone, probenecid, or sulfinpyrazone. All outpatient prescriptions of the four antihyperuricemic agents were extracted from a longitudinal cohort dataset with 1 000 000 individuals randomly sampled from the National Health Insurance Research Database. We examined utilization patterns of antihyperuricemic agents before and after the policy intervention (i.e., safety announcements and labeling changes of allopurinol and benzbromarone) in the year 2005. Results Following the safety announcements, there was a reduction in the number of allopurinol users in the first year of intervention (−95.82 users per 100 000 persons, 95%CI, [−166.84, −24.80]) and a continuous reduction afterward at a rate of −53.17 per 100 000 persons per year. The utilization of benzbromarone grew steadily before 2005 but decreased drastically after the intervention, with a 30.12% reduction in the number of users by the end of year 2008. There was no commensurate change in the number of probenecid or sulfinpyrazone users after the intervention. Conclusions Further research is required to evaluate the direct impacts of the safety announcements on clinical outcomes, treatment costs, and patient's quality of life. Copyright © 2013 John Wiley & Sons, Ltd.