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Title: The increase in prescriptions of bisphosphonates and the incidence proportion of osteonecrosis of the jaw after risk communication activities in Japan: a hospital-based cohort study.
Authors: Sumi, Eriko  kyouindb  KAKEN_id  orcid https://orcid.org/0000-0002-5028-0499 (unconfirmed)
Yamazaki, Toru
Tanaka, Shiro  kyouindb  KAKEN_id
Yamamoto, Keiichi
Nakayama, Takeo  kyouindb  KAKEN_id
Bessho, Kazuhisa  kyouindb  KAKEN_id
Yokode, Masayuki  kyouindb  KAKEN_id
Author's alias: 角, 栄里子
Keywords: risk communication
osteonecrosis of the jaw
oral bisphosphonates
pharmacoepidemiology
Issue Date: Apr-2014
Publisher: John Wiley & Sons, Ltd.
Journal title: Pharmacoepidemiology and drug safety
Volume: 23
Issue: 4
Start page: 398
End page: 405
Abstract: [Purpose]The purpose of this study was to investigate the impact of risk communication about bisphosphonate (BP)-related osteonecrosis of the jaw (ONJ) on the number of reported cases to the Drug Adverse Reactions Reporting System and on the incidence proportion of ONJ in a hospital-based cohort study in Japan. [Method]We conducted a survey of the safety information on BP-related ONJ available from regulatory authorities, pharmaceutical manufacturers and academic associations. We also performed a trend analysis of a dataset from the Drug Adverse Reactions Reporting System and a sub-analysis, using previously constructed data from a retrospective cohort study. [Results]Risk communication from pharmaceutical manufacturers and academic associations began within 1 year after revisions were made to the package inserts, in October 2006. Twenty times more cases of ONJ have been reported to regulatory authority since 2007, compared with the period before 2007. In our cohort, the incidence proportion of ONJ during and after 2009 was four times greater than before 2009. During this period, BPs were frequently prescribed, whereas there was no increase in the use of alternative agents, such as selective estrogen receptor modulators. [Conclusion]ONJ was increasingly diagnosed after risk communication efforts, but the impact of the communications was not clear. Safety notifications were diligently disseminated after the package insert was revised. However, there was no surveillance for ONJ before the revision.
Rights: © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
URI: http://hdl.handle.net/2433/180114
DOI(Published Version): 10.1002/pds.3562
PubMed ID: 24399628
Appears in Collections:Journal Articles

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