Self-limited febrile syndromes temporally associated with the use of propofol for sedation in gastrointestinal endoscopic procedures

Purpose To investigate cases of febrile illnesses in patients who received propofol for sedation during gastrointestinal endoscopy. Methods Active case finding for patients who underwent endoscopy between 1 April and 30 May 2007 and suffered unexplained fever, chills, or myalgia within 48 hour after...

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Veröffentlicht in:Pharmacoepidemiology and drug safety 2009-04, Vol.18 (4), p.344-348
Hauptverfasser: Blossom, D. B., Chen, T. H., Li, J., Langer, A. J., Carpenter, L. R., Glenshaw, M. T., Gould, C. V., Weltman, A., Srinivasan, A.
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container_end_page 348
container_issue 4
container_start_page 344
container_title Pharmacoepidemiology and drug safety
container_volume 18
creator Blossom, D. B.
Chen, T. H.
Li, J.
Langer, A. J.
Carpenter, L. R.
Glenshaw, M. T.
Gould, C. V.
Weltman, A.
Srinivasan, A.
description Purpose To investigate cases of febrile illnesses in patients who received propofol for sedation during gastrointestinal endoscopy. Methods Active case finding for patients who underwent endoscopy between 1 April and 30 May 2007 and suffered unexplained fever, chills, or myalgia within 48 hour after the procedure. We reviewed medications and clinical practices to find factors associated with the reactions. Results Seventy‐four cases at eight facilities in five states were identified yielding a rate of 36 reactions per 1000 procedures, compared with a baseline rate of 0.6 per 1000. The majority of patients experienced self‐limited fever (89.2%), chills (73.0%), or myalgia (63.5%). Blood samples from five patients were collected for culture; no organisms grew. All health care facilities that reported cases and fully participated in the investigation (n = 7) had received a common lot of propofol just before recognition of the first case. Bacterial endotoxin and sterility testing on unopened vials from this lot of propofol showed no abnormalities. Cases terminated after facilities stopped using the associated lot of propofol. Conclusions We found a temporal association between a particular lot of propofol and an outbreak of febrile illnesses at several healthcare facilities performing endoscopy. When propofol is used to sedate patients for endoscopy, fever is a rare outcome and healthcare professionals should investigate clusters of these reactions. Post‐procedure surveillance is important to identify possible medication reactions. Copyright © 2009 John Wiley & Sons, Ltd.
doi_str_mv 10.1002/pds.1696
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B. ; Chen, T. H. ; Li, J. ; Langer, A. J. ; Carpenter, L. R. ; Glenshaw, M. T. ; Gould, C. V. ; Weltman, A. ; Srinivasan, A.</creator><creatorcontrib>Blossom, D. B. ; Chen, T. H. ; Li, J. ; Langer, A. J. ; Carpenter, L. R. ; Glenshaw, M. T. ; Gould, C. V. ; Weltman, A. ; Srinivasan, A.</creatorcontrib><description>Purpose To investigate cases of febrile illnesses in patients who received propofol for sedation during gastrointestinal endoscopy. Methods Active case finding for patients who underwent endoscopy between 1 April and 30 May 2007 and suffered unexplained fever, chills, or myalgia within 48 hour after the procedure. We reviewed medications and clinical practices to find factors associated with the reactions. Results Seventy‐four cases at eight facilities in five states were identified yielding a rate of 36 reactions per 1000 procedures, compared with a baseline rate of 0.6 per 1000. The majority of patients experienced self‐limited fever (89.2%), chills (73.0%), or myalgia (63.5%). Blood samples from five patients were collected for culture; no organisms grew. All health care facilities that reported cases and fully participated in the investigation (n = 7) had received a common lot of propofol just before recognition of the first case. Bacterial endotoxin and sterility testing on unopened vials from this lot of propofol showed no abnormalities. Cases terminated after facilities stopped using the associated lot of propofol. Conclusions We found a temporal association between a particular lot of propofol and an outbreak of febrile illnesses at several healthcare facilities performing endoscopy. When propofol is used to sedate patients for endoscopy, fever is a rare outcome and healthcare professionals should investigate clusters of these reactions. Post‐procedure surveillance is important to identify possible medication reactions. Copyright © 2009 John Wiley &amp; Sons, Ltd.</description><identifier>ISSN: 1053-8569</identifier><identifier>EISSN: 1099-1557</identifier><identifier>DOI: 10.1002/pds.1696</identifier><identifier>PMID: 19242954</identifier><language>eng</language><publisher>Chichester, UK: John Wiley &amp; Sons, Ltd</publisher><subject>Adverse Drug Reaction Reporting Systems ; adverse effects ; Chills - chemically induced ; disease outbreak ; Drug Labeling ; endoscopy ; Endoscopy, Gastrointestinal ; fever ; Fever - chemically induced ; Humans ; Hypnotics and Sedatives - adverse effects ; Muscular Diseases - chemically induced ; propofol ; Propofol - adverse effects ; Quality Control ; Syndrome ; Time Factors ; United States ; United States Food and Drug Administration</subject><ispartof>Pharmacoepidemiology and drug safety, 2009-04, Vol.18 (4), p.344-348</ispartof><rights>Copyright © 2009 John Wiley &amp; Sons, Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4226-b8e9ba3ed47d41e0c0c9447cb1087afc606e59520320867c8acb9f0b9aa7e7413</citedby><cites>FETCH-LOGICAL-c4226-b8e9ba3ed47d41e0c0c9447cb1087afc606e59520320867c8acb9f0b9aa7e7413</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fpds.1696$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fpds.1696$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19242954$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Blossom, D. B.</creatorcontrib><creatorcontrib>Chen, T. H.</creatorcontrib><creatorcontrib>Li, J.</creatorcontrib><creatorcontrib>Langer, A. J.</creatorcontrib><creatorcontrib>Carpenter, L. R.</creatorcontrib><creatorcontrib>Glenshaw, M. T.</creatorcontrib><creatorcontrib>Gould, C. V.</creatorcontrib><creatorcontrib>Weltman, A.</creatorcontrib><creatorcontrib>Srinivasan, A.</creatorcontrib><title>Self-limited febrile syndromes temporally associated with the use of propofol for sedation in gastrointestinal endoscopic procedures</title><title>Pharmacoepidemiology and drug safety</title><addtitle>Pharmacoepidem. Drug Safe</addtitle><description>Purpose To investigate cases of febrile illnesses in patients who received propofol for sedation during gastrointestinal endoscopy. Methods Active case finding for patients who underwent endoscopy between 1 April and 30 May 2007 and suffered unexplained fever, chills, or myalgia within 48 hour after the procedure. We reviewed medications and clinical practices to find factors associated with the reactions. Results Seventy‐four cases at eight facilities in five states were identified yielding a rate of 36 reactions per 1000 procedures, compared with a baseline rate of 0.6 per 1000. The majority of patients experienced self‐limited fever (89.2%), chills (73.0%), or myalgia (63.5%). Blood samples from five patients were collected for culture; no organisms grew. All health care facilities that reported cases and fully participated in the investigation (n = 7) had received a common lot of propofol just before recognition of the first case. Bacterial endotoxin and sterility testing on unopened vials from this lot of propofol showed no abnormalities. Cases terminated after facilities stopped using the associated lot of propofol. Conclusions We found a temporal association between a particular lot of propofol and an outbreak of febrile illnesses at several healthcare facilities performing endoscopy. When propofol is used to sedate patients for endoscopy, fever is a rare outcome and healthcare professionals should investigate clusters of these reactions. Post‐procedure surveillance is important to identify possible medication reactions. 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B.</creator><creator>Chen, T. H.</creator><creator>Li, J.</creator><creator>Langer, A. J.</creator><creator>Carpenter, L. R.</creator><creator>Glenshaw, M. T.</creator><creator>Gould, C. V.</creator><creator>Weltman, A.</creator><creator>Srinivasan, A.</creator><general>John Wiley &amp; Sons, Ltd</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7T2</scope><scope>7T7</scope><scope>7U2</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>P64</scope></search><sort><creationdate>200904</creationdate><title>Self-limited febrile syndromes temporally associated with the use of propofol for sedation in gastrointestinal endoscopic procedures</title><author>Blossom, D. B. ; Chen, T. H. ; Li, J. ; Langer, A. J. ; Carpenter, L. R. ; Glenshaw, M. T. ; Gould, C. 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B.</creatorcontrib><creatorcontrib>Chen, T. H.</creatorcontrib><creatorcontrib>Li, J.</creatorcontrib><creatorcontrib>Langer, A. J.</creatorcontrib><creatorcontrib>Carpenter, L. R.</creatorcontrib><creatorcontrib>Glenshaw, M. T.</creatorcontrib><creatorcontrib>Gould, C. 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B.</au><au>Chen, T. H.</au><au>Li, J.</au><au>Langer, A. J.</au><au>Carpenter, L. R.</au><au>Glenshaw, M. T.</au><au>Gould, C. V.</au><au>Weltman, A.</au><au>Srinivasan, A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Self-limited febrile syndromes temporally associated with the use of propofol for sedation in gastrointestinal endoscopic procedures</atitle><jtitle>Pharmacoepidemiology and drug safety</jtitle><addtitle>Pharmacoepidem. Drug Safe</addtitle><date>2009-04</date><risdate>2009</risdate><volume>18</volume><issue>4</issue><spage>344</spage><epage>348</epage><pages>344-348</pages><issn>1053-8569</issn><eissn>1099-1557</eissn><abstract>Purpose To investigate cases of febrile illnesses in patients who received propofol for sedation during gastrointestinal endoscopy. Methods Active case finding for patients who underwent endoscopy between 1 April and 30 May 2007 and suffered unexplained fever, chills, or myalgia within 48 hour after the procedure. We reviewed medications and clinical practices to find factors associated with the reactions. Results Seventy‐four cases at eight facilities in five states were identified yielding a rate of 36 reactions per 1000 procedures, compared with a baseline rate of 0.6 per 1000. The majority of patients experienced self‐limited fever (89.2%), chills (73.0%), or myalgia (63.5%). Blood samples from five patients were collected for culture; no organisms grew. All health care facilities that reported cases and fully participated in the investigation (n = 7) had received a common lot of propofol just before recognition of the first case. Bacterial endotoxin and sterility testing on unopened vials from this lot of propofol showed no abnormalities. Cases terminated after facilities stopped using the associated lot of propofol. Conclusions We found a temporal association between a particular lot of propofol and an outbreak of febrile illnesses at several healthcare facilities performing endoscopy. When propofol is used to sedate patients for endoscopy, fever is a rare outcome and healthcare professionals should investigate clusters of these reactions. Post‐procedure surveillance is important to identify possible medication reactions. Copyright © 2009 John Wiley &amp; Sons, Ltd.</abstract><cop>Chichester, UK</cop><pub>John Wiley &amp; Sons, Ltd</pub><pmid>19242954</pmid><doi>10.1002/pds.1696</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record>
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subjects Adverse Drug Reaction Reporting Systems
adverse effects
Chills - chemically induced
disease outbreak
Drug Labeling
endoscopy
Endoscopy, Gastrointestinal
fever
Fever - chemically induced
Humans
Hypnotics and Sedatives - adverse effects
Muscular Diseases - chemically induced
propofol
Propofol - adverse effects
Quality Control
Syndrome
Time Factors
United States
United States Food and Drug Administration
title Self-limited febrile syndromes temporally associated with the use of propofol for sedation in gastrointestinal endoscopic procedures
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