Factors Affecting the Timing of Signal Detection of Adverse Drug Reactions.
We investigated factors affecting the timing of signal detection by comparing variations in reporting time of known and unknown ADRs after initial drug release in the USA. Data on adverse event reactions (AERs) submitted to U.S. FDA was used. Six ADRs associated with 6 drugs (rosuvastatin, aripipraz...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2015-01-01
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| Series: | PLoS ONE |
| Online Access: | http://europepmc.org/articles/PMC4671724?pdf=render |
| _version_ | 1818316938366943232 |
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| author | Masayuki Hashiguchi Shungo Imai Keiko Uehara Junya Maruyama Mikiko Shimizu Mayumi Mochizuki |
| author_facet | Masayuki Hashiguchi Shungo Imai Keiko Uehara Junya Maruyama Mikiko Shimizu Mayumi Mochizuki |
| author_sort | Masayuki Hashiguchi |
| collection | DOAJ |
| description | We investigated factors affecting the timing of signal detection by comparing variations in reporting time of known and unknown ADRs after initial drug release in the USA. Data on adverse event reactions (AERs) submitted to U.S. FDA was used. Six ADRs associated with 6 drugs (rosuvastatin, aripiprazole, teriparatide, telithromycin, exenatide, varenicline) were investigated: Changes in the proportional reporting ratio, reporting odds ratio, and information component as indexes of signal detection were followed every 3 months after each drugs release, and the time for detection of signals was investigated. The time for the detection of signal to be detected after drug release in the USA was 2-10 months for known ADRs and 19-44 months for unknown ones. The median lag time for known and unknown ADRs was 99.0-122.5 days and 185.5-306.0 days, respectively. When the FDA released advisory information on rare but potentially serious health risks of an unknown ADR, the time lag to report from the onset of ADRs to the FDA was shorter. This study suggested that one factor affecting signal detection time is whether an ADR was known or unknown at release. |
| first_indexed | 2024-12-13T09:29:23Z |
| format | Article |
| id | doaj.art-798efe35a243476db959e5403e640c32 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-13T09:29:23Z |
| publishDate | 2015-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-798efe35a243476db959e5403e640c322022-12-21T23:52:32ZengPublic Library of Science (PLoS)PLoS ONE1932-62032015-01-011012e014426310.1371/journal.pone.0144263Factors Affecting the Timing of Signal Detection of Adverse Drug Reactions.Masayuki HashiguchiShungo ImaiKeiko UeharaJunya MaruyamaMikiko ShimizuMayumi MochizukiWe investigated factors affecting the timing of signal detection by comparing variations in reporting time of known and unknown ADRs after initial drug release in the USA. Data on adverse event reactions (AERs) submitted to U.S. FDA was used. Six ADRs associated with 6 drugs (rosuvastatin, aripiprazole, teriparatide, telithromycin, exenatide, varenicline) were investigated: Changes in the proportional reporting ratio, reporting odds ratio, and information component as indexes of signal detection were followed every 3 months after each drugs release, and the time for detection of signals was investigated. The time for the detection of signal to be detected after drug release in the USA was 2-10 months for known ADRs and 19-44 months for unknown ones. The median lag time for known and unknown ADRs was 99.0-122.5 days and 185.5-306.0 days, respectively. When the FDA released advisory information on rare but potentially serious health risks of an unknown ADR, the time lag to report from the onset of ADRs to the FDA was shorter. This study suggested that one factor affecting signal detection time is whether an ADR was known or unknown at release.http://europepmc.org/articles/PMC4671724?pdf=render |
| spellingShingle | Masayuki Hashiguchi Shungo Imai Keiko Uehara Junya Maruyama Mikiko Shimizu Mayumi Mochizuki Factors Affecting the Timing of Signal Detection of Adverse Drug Reactions. PLoS ONE |
| title | Factors Affecting the Timing of Signal Detection of Adverse Drug Reactions. |
| title_full | Factors Affecting the Timing of Signal Detection of Adverse Drug Reactions. |
| title_fullStr | Factors Affecting the Timing of Signal Detection of Adverse Drug Reactions. |
| title_full_unstemmed | Factors Affecting the Timing of Signal Detection of Adverse Drug Reactions. |
| title_short | Factors Affecting the Timing of Signal Detection of Adverse Drug Reactions. |
| title_sort | factors affecting the timing of signal detection of adverse drug reactions |
| url | http://europepmc.org/articles/PMC4671724?pdf=render |
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