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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.

Sumi E, Yamazaki T, Tanaka S, Yamamoto K, Nakayama T, Bessho K, Yokode M - Pharmacoepidemiol Drug Saf (2014)

Bottom Line: 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.However, there was no surveillance for ONJ before the revision.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical Innovative Medicine, Institute for Advancement of Clinical and Translational Science, Kyoto University, Kyoto, Japan.

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Related in: MedlinePlus

Trends in the number of ONJ cases per year reported to the Drug Adverse Reactions Reporting System of the PMDA and risk communication activities. Legend: The cases of ONJ that were suspected adverse reactions to oral bisphosphonates and those that were suspected adverse reactions to other agents for osteoporosis, reported to the Drug Adverse Reactions Reporting System of the PMDA, are shown as a dark gray line and a light gray line, respectively. Black arrowhead: risk communication from the PMDA; gray arrowhead: risk communication from pharmaceutical manufacturers; arrow: risk communication from academic associations
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fig01: Trends in the number of ONJ cases per year reported to the Drug Adverse Reactions Reporting System of the PMDA and risk communication activities. Legend: The cases of ONJ that were suspected adverse reactions to oral bisphosphonates and those that were suspected adverse reactions to other agents for osteoporosis, reported to the Drug Adverse Reactions Reporting System of the PMDA, are shown as a dark gray line and a light gray line, respectively. Black arrowhead: risk communication from the PMDA; gray arrowhead: risk communication from pharmaceutical manufacturers; arrow: risk communication from academic associations

Mentions: An increasing number of cases of ONJ that were suspected adverse reactions to oral BPs were reported to the PMDA after 2007, immediately after the safety information was disseminated (Figure 1). These cases included those with a past history of ONJ (that is, cases of ONJ that occurred earlier were reported as cases of ONJ after 2004 in the system). There were nearly 20 times more reported cases of ONJ during and after 2007, compared with the number of cases during and before 2006. Reported cases of ONJ that are suspected to have been adverse reactions to osteoporosis medications other than BPs have been rare. For reference, the estimated numbers of patients taking oral BPs in Japan were 2 082 928 in 2007 and 2 470 979 in 2008.24


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.

Sumi E, Yamazaki T, Tanaka S, Yamamoto K, Nakayama T, Bessho K, Yokode M - Pharmacoepidemiol Drug Saf (2014)

Trends in the number of ONJ cases per year reported to the Drug Adverse Reactions Reporting System of the PMDA and risk communication activities. Legend: The cases of ONJ that were suspected adverse reactions to oral bisphosphonates and those that were suspected adverse reactions to other agents for osteoporosis, reported to the Drug Adverse Reactions Reporting System of the PMDA, are shown as a dark gray line and a light gray line, respectively. Black arrowhead: risk communication from the PMDA; gray arrowhead: risk communication from pharmaceutical manufacturers; arrow: risk communication from academic associations
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4230466&req=5

fig01: Trends in the number of ONJ cases per year reported to the Drug Adverse Reactions Reporting System of the PMDA and risk communication activities. Legend: The cases of ONJ that were suspected adverse reactions to oral bisphosphonates and those that were suspected adverse reactions to other agents for osteoporosis, reported to the Drug Adverse Reactions Reporting System of the PMDA, are shown as a dark gray line and a light gray line, respectively. Black arrowhead: risk communication from the PMDA; gray arrowhead: risk communication from pharmaceutical manufacturers; arrow: risk communication from academic associations
Mentions: An increasing number of cases of ONJ that were suspected adverse reactions to oral BPs were reported to the PMDA after 2007, immediately after the safety information was disseminated (Figure 1). These cases included those with a past history of ONJ (that is, cases of ONJ that occurred earlier were reported as cases of ONJ after 2004 in the system). There were nearly 20 times more reported cases of ONJ during and after 2007, compared with the number of cases during and before 2006. Reported cases of ONJ that are suspected to have been adverse reactions to osteoporosis medications other than BPs have been rare. For reference, the estimated numbers of patients taking oral BPs in Japan were 2 082 928 in 2007 and 2 470 979 in 2008.24

Bottom Line: 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.However, there was no surveillance for ONJ before the revision.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical Innovative Medicine, Institute for Advancement of Clinical and Translational Science, Kyoto University, Kyoto, Japan.

Show MeSH
Related in: MedlinePlus