Evaluation of pregabalin‐induced adverse events related to falls using the FDA adverse event reporting system and Japanese Adverse Drug Event Report databases
Summary What is known and objective Pregabalin is used for neuropathic and postherpetic pain and generalized anxiety. The aim of this study was to obtain the onset profiles of adverse events (AE) related to falls (AEFs) such as “somnolence,” “dizziness,” “loss of consciousness” and “fall” onset and...
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| Veröffentlicht in: | Journal of clinical pharmacy and therapeutics 2019-04, Vol.44 (2), p.285-291 |
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| creator | Mukai, Ririka Hasegawa, Shiori Umetsu, Ryogo Nakao, Satoshi Shimada, Kazuyo Uranishi, Hiroaki Masuta, Mayuko Suzuki, Honami Nishibata, Yuri Nakamura, Mitsuhiro |
| description | Summary
What is known and objective
Pregabalin is used for neuropathic and postherpetic pain and generalized anxiety. The aim of this study was to obtain the onset profiles of adverse events (AE) related to falls (AEFs) such as “somnolence,” “dizziness,” “loss of consciousness” and “fall” onset and several clinical factor combinations such as age and administered dose, using spontaneous reporting system (SRS) analysis such as the US Food and Drug Administration Adverse Event Reporting System (FAERS) database and the Japanese Adverse Drug Event Report (JADER) database.
Methods
We used the reporting odds ratio (ROR) to analyse the association between pregabalin and AEFs. Additionally, we used the time‐to‐onset analysis.
Results and discussion
The crude RORs of AEFs such as somnolence and dizziness were higher than one for both the databases. The adjusted RORs for AEFs in the ≥60 years age group compared to those in the |
| doi_str_mv | 10.1111/jcpt.12790 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_2187595895</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2187595895</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4850-ab2bd8c370548eb9d1ac0ec12a4d2f2650c5778519974dfb7bf59bf0e7e11c663</originalsourceid><addsrcrecordid>eNp90d1q2zAUB3AxWpY0280eYAh6N3AqyZZlXYY0aRsKHSO7NrJ0nDk4tivJKbnbI_QR-mx9kiofHfRmuhFIv_M_Qgehb5SMaVhXa935MWVCkk9oSOOUR0xQcoaGhKUySgQTA3Th3JoQkgoWf0aDmPBUJoIM0ctsq-pe-aptcFvizsJKFaqumte_z1Vjeg0GK7MF6wDDFhrvsIVa-XDsW1yquna4d1Wzwv4P4Pn15KMOuGut39-7nfOwwaoxeKE61UAwk5O9tv0Kzw4Fvw4F2Cgf3uHAfUHnoYuDr6d9hH7PZ8vpbXT_cHM3ndxHOsk4iVTBCpPpWBCeZFBIQ5UmoClTiWElSznRXIiMUylFYspCFCWXRUlAAKU6TeMRujzmdrZ97MH5fN32tgktc0YzwSXPJA_qx1Fp2zpnocw7W22U3eWU5Pth5Pth5IdhBPz9FNkXGzD_6PvvB0CP4KmqYfefqHwx_bk8hr4BrwuYpQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2187595895</pqid></control><display><type>article</type><title>Evaluation of pregabalin‐induced adverse events related to falls using the FDA adverse event reporting system and Japanese Adverse Drug Event Report databases</title><source>Wiley Online Library Journals Frontfile Complete</source><creator>Mukai, Ririka ; Hasegawa, Shiori ; Umetsu, Ryogo ; Nakao, Satoshi ; Shimada, Kazuyo ; Uranishi, Hiroaki ; Masuta, Mayuko ; Suzuki, Honami ; Nishibata, Yuri ; Nakamura, Mitsuhiro</creator><creatorcontrib>Mukai, Ririka ; Hasegawa, Shiori ; Umetsu, Ryogo ; Nakao, Satoshi ; Shimada, Kazuyo ; Uranishi, Hiroaki ; Masuta, Mayuko ; Suzuki, Honami ; Nishibata, Yuri ; Nakamura, Mitsuhiro</creatorcontrib><description>Summary
What is known and objective
Pregabalin is used for neuropathic and postherpetic pain and generalized anxiety. The aim of this study was to obtain the onset profiles of adverse events (AE) related to falls (AEFs) such as “somnolence,” “dizziness,” “loss of consciousness” and “fall” onset and several clinical factor combinations such as age and administered dose, using spontaneous reporting system (SRS) analysis such as the US Food and Drug Administration Adverse Event Reporting System (FAERS) database and the Japanese Adverse Drug Event Report (JADER) database.
Methods
We used the reporting odds ratio (ROR) to analyse the association between pregabalin and AEFs. Additionally, we used the time‐to‐onset analysis.
Results and discussion
The crude RORs of AEFs such as somnolence and dizziness were higher than one for both the databases. The adjusted RORs for AEFs in the ≥60 years age group compared to those in the <60 years age group for the FAERS and JADER databases were 1.46 (95% CI = 1.39‐1.53; P < 0.0001) and 2.58 (95% CI = 2.06‐3.27; P < 0.0001), respectively. In the JADER database, the median and quartile range for AEFs with pregabalin, at ≤75 and ≥100 mg/d, were 2.0 (0.0‐5.0) and 2.0 (1.0‐4.3) days, respectively. Additionally, 57.2% of AEFs (four preferred terms) were observed within 2 days after administration.
What is new and conclusions
This study is the first to evaluate the relationship between pregabalin and AEFs using the SRS analysis strategy. The risk of AEFs in the ≥60 years age group might increase compared to that in the <60 years age group. AEFs occurred almost within 1 week after pregabalin administration, and the median for AEF onset was 2 days. Our results show that patients should be closely monitored for AEFs for 1 week from the start of pregabalin administration.
This study was the first to evaluate the relationship between pregabalin and adverse events related to falls (AEFs) using the spontaneous reporting system analysis strategy. The risk of AEFs in the ≥60 years age group might increase compared to that in the <60 years age group. Most AEFs occurred within the first week after administration, and the median for AEF onset was 2 days.</description><identifier>ISSN: 0269-4727</identifier><identifier>EISSN: 1365-2710</identifier><identifier>DOI: 10.1111/jcpt.12790</identifier><identifier>PMID: 30569470</identifier><language>eng</language><publisher>England: Hindawi Limited</publisher><subject>adverse event ; Age groups ; Anxiety ; FAERS ; fall ; JADER ; Neuralgia ; pregabalin ; Regulatory agencies</subject><ispartof>Journal of clinical pharmacy and therapeutics, 2019-04, Vol.44 (2), p.285-291</ispartof><rights>2018 John Wiley & Sons Ltd</rights><rights>2018 John Wiley & Sons Ltd.</rights><rights>Copyright © 2019 John Wiley & Sons Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4850-ab2bd8c370548eb9d1ac0ec12a4d2f2650c5778519974dfb7bf59bf0e7e11c663</citedby><cites>FETCH-LOGICAL-c4850-ab2bd8c370548eb9d1ac0ec12a4d2f2650c5778519974dfb7bf59bf0e7e11c663</cites><orcidid>0000-0002-5062-5522</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fjcpt.12790$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjcpt.12790$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30569470$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mukai, Ririka</creatorcontrib><creatorcontrib>Hasegawa, Shiori</creatorcontrib><creatorcontrib>Umetsu, Ryogo</creatorcontrib><creatorcontrib>Nakao, Satoshi</creatorcontrib><creatorcontrib>Shimada, Kazuyo</creatorcontrib><creatorcontrib>Uranishi, Hiroaki</creatorcontrib><creatorcontrib>Masuta, Mayuko</creatorcontrib><creatorcontrib>Suzuki, Honami</creatorcontrib><creatorcontrib>Nishibata, Yuri</creatorcontrib><creatorcontrib>Nakamura, Mitsuhiro</creatorcontrib><title>Evaluation of pregabalin‐induced adverse events related to falls using the FDA adverse event reporting system and Japanese Adverse Drug Event Report databases</title><title>Journal of clinical pharmacy and therapeutics</title><addtitle>J Clin Pharm Ther</addtitle><description>Summary
What is known and objective
Pregabalin is used for neuropathic and postherpetic pain and generalized anxiety. The aim of this study was to obtain the onset profiles of adverse events (AE) related to falls (AEFs) such as “somnolence,” “dizziness,” “loss of consciousness” and “fall” onset and several clinical factor combinations such as age and administered dose, using spontaneous reporting system (SRS) analysis such as the US Food and Drug Administration Adverse Event Reporting System (FAERS) database and the Japanese Adverse Drug Event Report (JADER) database.
Methods
We used the reporting odds ratio (ROR) to analyse the association between pregabalin and AEFs. Additionally, we used the time‐to‐onset analysis.
Results and discussion
The crude RORs of AEFs such as somnolence and dizziness were higher than one for both the databases. The adjusted RORs for AEFs in the ≥60 years age group compared to those in the <60 years age group for the FAERS and JADER databases were 1.46 (95% CI = 1.39‐1.53; P < 0.0001) and 2.58 (95% CI = 2.06‐3.27; P < 0.0001), respectively. In the JADER database, the median and quartile range for AEFs with pregabalin, at ≤75 and ≥100 mg/d, were 2.0 (0.0‐5.0) and 2.0 (1.0‐4.3) days, respectively. Additionally, 57.2% of AEFs (four preferred terms) were observed within 2 days after administration.
What is new and conclusions
This study is the first to evaluate the relationship between pregabalin and AEFs using the SRS analysis strategy. The risk of AEFs in the ≥60 years age group might increase compared to that in the <60 years age group. AEFs occurred almost within 1 week after pregabalin administration, and the median for AEF onset was 2 days. Our results show that patients should be closely monitored for AEFs for 1 week from the start of pregabalin administration.
This study was the first to evaluate the relationship between pregabalin and adverse events related to falls (AEFs) using the spontaneous reporting system analysis strategy. The risk of AEFs in the ≥60 years age group might increase compared to that in the <60 years age group. Most AEFs occurred within the first week after administration, and the median for AEF onset was 2 days.</description><subject>adverse event</subject><subject>Age groups</subject><subject>Anxiety</subject><subject>FAERS</subject><subject>fall</subject><subject>JADER</subject><subject>Neuralgia</subject><subject>pregabalin</subject><subject>Regulatory agencies</subject><issn>0269-4727</issn><issn>1365-2710</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><recordid>eNp90d1q2zAUB3AxWpY0280eYAh6N3AqyZZlXYY0aRsKHSO7NrJ0nDk4tivJKbnbI_QR-mx9kiofHfRmuhFIv_M_Qgehb5SMaVhXa935MWVCkk9oSOOUR0xQcoaGhKUySgQTA3Th3JoQkgoWf0aDmPBUJoIM0ctsq-pe-aptcFvizsJKFaqumte_z1Vjeg0GK7MF6wDDFhrvsIVa-XDsW1yquna4d1Wzwv4P4Pn15KMOuGut39-7nfOwwaoxeKE61UAwk5O9tv0Kzw4Fvw4F2Cgf3uHAfUHnoYuDr6d9hH7PZ8vpbXT_cHM3ndxHOsk4iVTBCpPpWBCeZFBIQ5UmoClTiWElSznRXIiMUylFYspCFCWXRUlAAKU6TeMRujzmdrZ97MH5fN32tgktc0YzwSXPJA_qx1Fp2zpnocw7W22U3eWU5Pth5Pth5IdhBPz9FNkXGzD_6PvvB0CP4KmqYfefqHwx_bk8hr4BrwuYpQ</recordid><startdate>201904</startdate><enddate>201904</enddate><creator>Mukai, Ririka</creator><creator>Hasegawa, Shiori</creator><creator>Umetsu, Ryogo</creator><creator>Nakao, Satoshi</creator><creator>Shimada, Kazuyo</creator><creator>Uranishi, Hiroaki</creator><creator>Masuta, Mayuko</creator><creator>Suzuki, Honami</creator><creator>Nishibata, Yuri</creator><creator>Nakamura, Mitsuhiro</creator><general>Hindawi Limited</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TM</scope><scope>7TO</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><orcidid>https://orcid.org/0000-0002-5062-5522</orcidid></search><sort><creationdate>201904</creationdate><title>Evaluation of pregabalin‐induced adverse events related to falls using the FDA adverse event reporting system and Japanese Adverse Drug Event Report databases</title><author>Mukai, Ririka ; Hasegawa, Shiori ; Umetsu, Ryogo ; Nakao, Satoshi ; Shimada, Kazuyo ; Uranishi, Hiroaki ; Masuta, Mayuko ; Suzuki, Honami ; Nishibata, Yuri ; Nakamura, Mitsuhiro</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4850-ab2bd8c370548eb9d1ac0ec12a4d2f2650c5778519974dfb7bf59bf0e7e11c663</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>adverse event</topic><topic>Age groups</topic><topic>Anxiety</topic><topic>FAERS</topic><topic>fall</topic><topic>JADER</topic><topic>Neuralgia</topic><topic>pregabalin</topic><topic>Regulatory agencies</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mukai, Ririka</creatorcontrib><creatorcontrib>Hasegawa, Shiori</creatorcontrib><creatorcontrib>Umetsu, Ryogo</creatorcontrib><creatorcontrib>Nakao, Satoshi</creatorcontrib><creatorcontrib>Shimada, Kazuyo</creatorcontrib><creatorcontrib>Uranishi, Hiroaki</creatorcontrib><creatorcontrib>Masuta, Mayuko</creatorcontrib><creatorcontrib>Suzuki, Honami</creatorcontrib><creatorcontrib>Nishibata, Yuri</creatorcontrib><creatorcontrib>Nakamura, Mitsuhiro</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><jtitle>Journal of clinical pharmacy and therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mukai, Ririka</au><au>Hasegawa, Shiori</au><au>Umetsu, Ryogo</au><au>Nakao, Satoshi</au><au>Shimada, Kazuyo</au><au>Uranishi, Hiroaki</au><au>Masuta, Mayuko</au><au>Suzuki, Honami</au><au>Nishibata, Yuri</au><au>Nakamura, Mitsuhiro</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of pregabalin‐induced adverse events related to falls using the FDA adverse event reporting system and Japanese Adverse Drug Event Report databases</atitle><jtitle>Journal of clinical pharmacy and therapeutics</jtitle><addtitle>J Clin Pharm Ther</addtitle><date>2019-04</date><risdate>2019</risdate><volume>44</volume><issue>2</issue><spage>285</spage><epage>291</epage><pages>285-291</pages><issn>0269-4727</issn><eissn>1365-2710</eissn><abstract>Summary
What is known and objective
Pregabalin is used for neuropathic and postherpetic pain and generalized anxiety. The aim of this study was to obtain the onset profiles of adverse events (AE) related to falls (AEFs) such as “somnolence,” “dizziness,” “loss of consciousness” and “fall” onset and several clinical factor combinations such as age and administered dose, using spontaneous reporting system (SRS) analysis such as the US Food and Drug Administration Adverse Event Reporting System (FAERS) database and the Japanese Adverse Drug Event Report (JADER) database.
Methods
We used the reporting odds ratio (ROR) to analyse the association between pregabalin and AEFs. Additionally, we used the time‐to‐onset analysis.
Results and discussion
The crude RORs of AEFs such as somnolence and dizziness were higher than one for both the databases. The adjusted RORs for AEFs in the ≥60 years age group compared to those in the <60 years age group for the FAERS and JADER databases were 1.46 (95% CI = 1.39‐1.53; P < 0.0001) and 2.58 (95% CI = 2.06‐3.27; P < 0.0001), respectively. In the JADER database, the median and quartile range for AEFs with pregabalin, at ≤75 and ≥100 mg/d, were 2.0 (0.0‐5.0) and 2.0 (1.0‐4.3) days, respectively. Additionally, 57.2% of AEFs (four preferred terms) were observed within 2 days after administration.
What is new and conclusions
This study is the first to evaluate the relationship between pregabalin and AEFs using the SRS analysis strategy. The risk of AEFs in the ≥60 years age group might increase compared to that in the <60 years age group. AEFs occurred almost within 1 week after pregabalin administration, and the median for AEF onset was 2 days. Our results show that patients should be closely monitored for AEFs for 1 week from the start of pregabalin administration.
This study was the first to evaluate the relationship between pregabalin and adverse events related to falls (AEFs) using the spontaneous reporting system analysis strategy. The risk of AEFs in the ≥60 years age group might increase compared to that in the <60 years age group. Most AEFs occurred within the first week after administration, and the median for AEF onset was 2 days.</abstract><cop>England</cop><pub>Hindawi Limited</pub><pmid>30569470</pmid><doi>10.1111/jcpt.12790</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-5062-5522</orcidid><oa>free_for_read</oa></addata></record> |
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| source | Wiley Online Library Journals Frontfile Complete |
| subjects | adverse event Age groups Anxiety FAERS fall JADER Neuralgia pregabalin Regulatory agencies |
| title | Evaluation of pregabalin‐induced adverse events related to falls using the FDA adverse event reporting system and Japanese Adverse Drug Event Report databases |
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