Serious adverse drug reactions with tramadol reported to the French pharmacovigilance database between 2011 and 2015
Tramadol is an opioid and a serotonin reuptake inhibitor drug. It is approved for moderate to severe pain in adults. The aim of this study was to assess tramadol safety through a national pharmacovigilance study in France since dextropropoxyphen withdrawal in 2011. We described all serious adverse d...
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| Veröffentlicht in: | Therapie 2017-12, Vol.72 (6), p.615-624 |
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| creator | Moulis, Florence Rousseau, Vanessa Abadie, Delphine Masmoudi, Kamel Micallef, Joëlle Vigier, Caroline Pierre, Sabrina Dautriche, Anne Montastruc, François Montastruc, Jean-Louis |
| description | Tramadol is an opioid and a serotonin reuptake inhibitor drug. It is approved for moderate to severe pain in adults. The aim of this study was to assess tramadol safety through a national pharmacovigilance study in France since dextropropoxyphen withdrawal in 2011.
We described all serious adverse drug reactions (SADRs) reported with tramadol in adults in the French National PharmacoVigilance Database from August 1st, 2011 to December 31st, 2015.
We identified 1512 SADRs during the study period. The most frequently reported SADRs were neurological (29.4%, including troubles of consciousness [13.2%] and seizures [6.7%]), psychiatric (22.8%, including confusions [14.6%] and hallucinations [7.3%]) and gastrointestinal (17.0%, mostly nausea and vomiting [9.6%]). Unexpected SADRs were also reported: hyponatremia, cholestatic hepatitis, serotonin syndrome.
This study demonstrates new unexpected hepatic and metabolic SADRs. Tramadol alone can induce serotonin syndrome in overdose situations. |
| doi_str_mv | 10.1016/j.therap.2017.03.004 |
| format | Article |
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We described all serious adverse drug reactions (SADRs) reported with tramadol in adults in the French National PharmacoVigilance Database from August 1st, 2011 to December 31st, 2015.
We identified 1512 SADRs during the study period. The most frequently reported SADRs were neurological (29.4%, including troubles of consciousness [13.2%] and seizures [6.7%]), psychiatric (22.8%, including confusions [14.6%] and hallucinations [7.3%]) and gastrointestinal (17.0%, mostly nausea and vomiting [9.6%]). Unexpected SADRs were also reported: hyponatremia, cholestatic hepatitis, serotonin syndrome.
This study demonstrates new unexpected hepatic and metabolic SADRs. Tramadol alone can induce serotonin syndrome in overdose situations.</description><identifier>ISSN: 0040-5957</identifier><identifier>DOI: 10.1016/j.therap.2017.03.004</identifier><identifier>PMID: 28755832</identifier><language>fre</language><publisher>France</publisher><subject>Adolescent ; Adult ; Adverse Drug Reaction Reporting Systems - statistics & numerical data ; Aged ; Aged, 80 and over ; Analgesics, Opioid - administration & dosage ; Analgesics, Opioid - adverse effects ; Databases, Factual ; Drug Overdose - epidemiology ; Female ; France - epidemiology ; Humans ; Male ; Middle Aged ; Pain - drug therapy ; Pharmacovigilance ; Tramadol - administration & dosage ; Tramadol - adverse effects ; Young Adult</subject><ispartof>Therapie, 2017-12, Vol.72 (6), p.615-624</ispartof><rights>Copyright © 2017 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28755832$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Moulis, Florence</creatorcontrib><creatorcontrib>Rousseau, Vanessa</creatorcontrib><creatorcontrib>Abadie, Delphine</creatorcontrib><creatorcontrib>Masmoudi, Kamel</creatorcontrib><creatorcontrib>Micallef, Joëlle</creatorcontrib><creatorcontrib>Vigier, Caroline</creatorcontrib><creatorcontrib>Pierre, Sabrina</creatorcontrib><creatorcontrib>Dautriche, Anne</creatorcontrib><creatorcontrib>Montastruc, François</creatorcontrib><creatorcontrib>Montastruc, Jean-Louis</creatorcontrib><title>Serious adverse drug reactions with tramadol reported to the French pharmacovigilance database between 2011 and 2015</title><title>Therapie</title><addtitle>Therapie</addtitle><description>Tramadol is an opioid and a serotonin reuptake inhibitor drug. It is approved for moderate to severe pain in adults. The aim of this study was to assess tramadol safety through a national pharmacovigilance study in France since dextropropoxyphen withdrawal in 2011.
We described all serious adverse drug reactions (SADRs) reported with tramadol in adults in the French National PharmacoVigilance Database from August 1st, 2011 to December 31st, 2015.
We identified 1512 SADRs during the study period. The most frequently reported SADRs were neurological (29.4%, including troubles of consciousness [13.2%] and seizures [6.7%]), psychiatric (22.8%, including confusions [14.6%] and hallucinations [7.3%]) and gastrointestinal (17.0%, mostly nausea and vomiting [9.6%]). Unexpected SADRs were also reported: hyponatremia, cholestatic hepatitis, serotonin syndrome.
This study demonstrates new unexpected hepatic and metabolic SADRs. Tramadol alone can induce serotonin syndrome in overdose situations.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Adverse Drug Reaction Reporting Systems - statistics & numerical data</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Analgesics, Opioid - administration & dosage</subject><subject>Analgesics, Opioid - adverse effects</subject><subject>Databases, Factual</subject><subject>Drug Overdose - epidemiology</subject><subject>Female</subject><subject>France - epidemiology</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Pain - drug therapy</subject><subject>Pharmacovigilance</subject><subject>Tramadol - administration & dosage</subject><subject>Tramadol - adverse effects</subject><subject>Young Adult</subject><issn>0040-5957</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo1UMtOwzAQ9AFES-EPEPKRS4IfcRwfUcVLqsSB3qONvW1SNQ8cpxV_w7fwZRhRLrur0ezM7BJyw1nKGc_vd2mo0cOQCsZ1ymTKWHZG5rGyRBmlZ-RyHHeMCa6NviAzUWilCinmZHpH3_TTSMEd0I9InZ-21CPY0PTdSI9NqGnw0ILr9xEfeh_Q0dDT6EifPHa2pkMNvgXbH5pts4fORhUIUEGUqzAcETsag_HvL-jc76SuyPkG9iNen_qCrJ8e18uXZPX2_Lp8WCVbnuuQcFUYxg3PZCUQ0UjLc5lzoU1hlBAbJa3NNVjHnDAiY0ZYQJmrzIqCFVouyN2f7OD7jwnHULbNaHEfM2K8ueRxKRpkkkXq7Yk6VS26cvBNC_6z_P-U_AEeh2qy</recordid><startdate>20171201</startdate><enddate>20171201</enddate><creator>Moulis, Florence</creator><creator>Rousseau, Vanessa</creator><creator>Abadie, Delphine</creator><creator>Masmoudi, Kamel</creator><creator>Micallef, Joëlle</creator><creator>Vigier, Caroline</creator><creator>Pierre, Sabrina</creator><creator>Dautriche, Anne</creator><creator>Montastruc, François</creator><creator>Montastruc, Jean-Louis</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>20171201</creationdate><title>Serious adverse drug reactions with tramadol reported to the French pharmacovigilance database between 2011 and 2015</title><author>Moulis, Florence ; Rousseau, Vanessa ; Abadie, Delphine ; Masmoudi, Kamel ; Micallef, Joëlle ; Vigier, Caroline ; Pierre, Sabrina ; Dautriche, Anne ; Montastruc, François ; Montastruc, Jean-Louis</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-g167t-1589019143b2eee93c1636127989522f53cc67acd0d2924092cae3654c280873</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>fre</language><creationdate>2017</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Adverse Drug Reaction Reporting Systems - statistics & numerical data</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Analgesics, Opioid - administration & dosage</topic><topic>Analgesics, Opioid - adverse effects</topic><topic>Databases, Factual</topic><topic>Drug Overdose - epidemiology</topic><topic>Female</topic><topic>France - epidemiology</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Pain - drug therapy</topic><topic>Pharmacovigilance</topic><topic>Tramadol - administration & dosage</topic><topic>Tramadol - adverse effects</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Moulis, Florence</creatorcontrib><creatorcontrib>Rousseau, Vanessa</creatorcontrib><creatorcontrib>Abadie, Delphine</creatorcontrib><creatorcontrib>Masmoudi, Kamel</creatorcontrib><creatorcontrib>Micallef, Joëlle</creatorcontrib><creatorcontrib>Vigier, Caroline</creatorcontrib><creatorcontrib>Pierre, Sabrina</creatorcontrib><creatorcontrib>Dautriche, Anne</creatorcontrib><creatorcontrib>Montastruc, François</creatorcontrib><creatorcontrib>Montastruc, Jean-Louis</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>Therapie</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Moulis, Florence</au><au>Rousseau, Vanessa</au><au>Abadie, Delphine</au><au>Masmoudi, Kamel</au><au>Micallef, Joëlle</au><au>Vigier, Caroline</au><au>Pierre, Sabrina</au><au>Dautriche, Anne</au><au>Montastruc, François</au><au>Montastruc, Jean-Louis</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Serious adverse drug reactions with tramadol reported to the French pharmacovigilance database between 2011 and 2015</atitle><jtitle>Therapie</jtitle><addtitle>Therapie</addtitle><date>2017-12-01</date><risdate>2017</risdate><volume>72</volume><issue>6</issue><spage>615</spage><epage>624</epage><pages>615-624</pages><issn>0040-5957</issn><abstract>Tramadol is an opioid and a serotonin reuptake inhibitor drug. It is approved for moderate to severe pain in adults. The aim of this study was to assess tramadol safety through a national pharmacovigilance study in France since dextropropoxyphen withdrawal in 2011.
We described all serious adverse drug reactions (SADRs) reported with tramadol in adults in the French National PharmacoVigilance Database from August 1st, 2011 to December 31st, 2015.
We identified 1512 SADRs during the study period. The most frequently reported SADRs were neurological (29.4%, including troubles of consciousness [13.2%] and seizures [6.7%]), psychiatric (22.8%, including confusions [14.6%] and hallucinations [7.3%]) and gastrointestinal (17.0%, mostly nausea and vomiting [9.6%]). Unexpected SADRs were also reported: hyponatremia, cholestatic hepatitis, serotonin syndrome.
This study demonstrates new unexpected hepatic and metabolic SADRs. Tramadol alone can induce serotonin syndrome in overdose situations.</abstract><cop>France</cop><pmid>28755832</pmid><doi>10.1016/j.therap.2017.03.004</doi><tpages>10</tpages></addata></record> |
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| subjects | Adolescent Adult Adverse Drug Reaction Reporting Systems - statistics & numerical data Aged Aged, 80 and over Analgesics, Opioid - administration & dosage Analgesics, Opioid - adverse effects Databases, Factual Drug Overdose - epidemiology Female France - epidemiology Humans Male Middle Aged Pain - drug therapy Pharmacovigilance Tramadol - administration & dosage Tramadol - adverse effects Young Adult |
| title | Serious adverse drug reactions with tramadol reported to the French pharmacovigilance database between 2011 and 2015 |
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