No differences between men and women in adverse drug reactions related to psychotropic drugs: a survey from France, Italy and Spain
A large number of studies have suggested that being a woman represents a potential risk factor for the development of adverse drug reactions (ADRs). The aim of this study is to further explore the differences between men and women with regard to reported ADRs, particularly those associated with psyc...
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| Veröffentlicht in: | Fundamental & clinical pharmacology 2014-06, Vol.28 (3), p.342-348 |
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| creator | D'Incau, Paola Lapeyre-Mestre, Maryse Carvajal, Alfonso Donati, Monia Salado, Inés Rodriguez, Lauriane Sáinz, María Escudero, Antonio Conforti, Anita |
| description | A large number of studies have suggested that being a woman represents a potential risk factor for the development of adverse drug reactions (ADRs). The aim of this study is to further explore the differences between men and women with regard to reported ADRs, particularly those associated with psychotropic drugs. We used spontaneous reports of suspected ADRs collected by Midi‐Pyrénées (France), Veneto (Italy) and Castilla y León (Spain) Regional Pharmacovigilance Centres (January 2007–December 2009). All the reports including a psychotropic medication were selected in a first step; age distribution, seriousness and type of ADRs were compared between men and women. Reports of nonpsychotropic drugs were similarly identified and treated. The absolute number of reports and the proportion, considering population, were higher in women than in men. This was observed for all reports, but was particularly higher for psychotropic drugs (592 vs. 375; P |
| doi_str_mv | 10.1111/fcp.12032 |
| format | Article |
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The aim of this study is to further explore the differences between men and women with regard to reported ADRs, particularly those associated with psychotropic drugs. We used spontaneous reports of suspected ADRs collected by Midi‐Pyrénées (France), Veneto (Italy) and Castilla y León (Spain) Regional Pharmacovigilance Centres (January 2007–December 2009). All the reports including a psychotropic medication were selected in a first step; age distribution, seriousness and type of ADRs were compared between men and women. Reports of nonpsychotropic drugs were similarly identified and treated. The absolute number of reports and the proportion, considering population, were higher in women than in men. This was observed for all reports, but was particularly higher for psychotropic drugs (592 vs. 375; P < 0.001) than for nonpsychotropics drugs (5193 vs. 4035; P < 0.001). Antidepressants were the most reported (women, 303; men, 141; P < 0.001); the reporting rates (number of reports divided by exposed patients in the same period, estimated through sales data) for these drugs, however, were not significantly different between women (0.87 cases per 10 000 treated persons per year) and men (0.81 cases per 10 000 treated persons per year). Although there was a higher number of reports of ADRs in women, ADR reporting rates might be similar as highlighted by the case of antidepressants. Antidepressant ADRs in fact were similarly reported in men and in women. Gender differences are sometimes subtle and difficult to explore. International networks, as the one established for this study, do contribute to better analyse problems associated with medications.</description><identifier>ISSN: 0767-3981</identifier><identifier>EISSN: 1472-8206</identifier><identifier>DOI: 10.1111/fcp.12032</identifier><identifier>PMID: 23617454</identifier><identifier>CODEN: FCPHEZ</identifier><language>eng</language><publisher>Oxford: Blackwell Publishing Ltd</publisher><subject>Adverse Drug Reaction Reporting Systems ; Biological and medical sciences ; Chi-Square Distribution ; Data Interpretation, Statistical ; Drug-Related Side Effects and Adverse Reactions - epidemiology ; Drug-Related Side Effects and Adverse Reactions - etiology ; France - epidemiology ; gender ; Humans ; Italy - epidemiology ; Male ; Medical sciences ; Pharmacology. 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Antidepressants were the most reported (women, 303; men, 141; P < 0.001); the reporting rates (number of reports divided by exposed patients in the same period, estimated through sales data) for these drugs, however, were not significantly different between women (0.87 cases per 10 000 treated persons per year) and men (0.81 cases per 10 000 treated persons per year). Although there was a higher number of reports of ADRs in women, ADR reporting rates might be similar as highlighted by the case of antidepressants. Antidepressant ADRs in fact were similarly reported in men and in women. Gender differences are sometimes subtle and difficult to explore. International networks, as the one established for this study, do contribute to better analyse problems associated with medications.</description><subject>Adverse Drug Reaction Reporting Systems</subject><subject>Biological and medical sciences</subject><subject>Chi-Square Distribution</subject><subject>Data Interpretation, Statistical</subject><subject>Drug-Related Side Effects and Adverse Reactions - epidemiology</subject><subject>Drug-Related Side Effects and Adverse Reactions - etiology</subject><subject>France - epidemiology</subject><subject>gender</subject><subject>Humans</subject><subject>Italy - epidemiology</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Pharmacology. Drug treatments</subject><subject>pharmacovigilance</subject><subject>Psychotropic Drugs - adverse effects</subject><subject>psychotropics</subject><subject>reporting</subject><subject>Sex Characteristics</subject><subject>Spain - epidemiology</subject><issn>0767-3981</issn><issn>1472-8206</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkUtv1DAUhS0EotPCgj-AvEFiQVo_4jhhByNmaDUqIIpgZznONRiSONhJp1nzx_E8KJYsH8vfuVfXB6FnlJzTtC6sGc4pI5w9QAuaS5aVjBQP0YLIQma8KukJOo3xJyFUElo8RieMF1TmIl-gP9ceN85aCNAbiLiGcQvQ4y5t3Td463fKpUtzCyECbsL0HQfQZnS-j0m1eoQGjx4PcTY__Bj84Mwei6-xxnEKtzBjG3yHV0GnJq_w5ajbeV_-86Bd_wQ9srqN8PR4nqEvq3c3y_fZ5sP6cvlmkzkucpbJgggpqGG2tIIYkdvapqklLRtdV1QzKXSe20pIK4qG5ryyYKE2DRRM1pTxM_TyUHcI_vcEcVSdiwbaVvfgp6iooJJXlaxkQp8f0anuoFFDcJ0Os_r3cQl4cQR0NLq1u8lc_M-VvKJlteMuDtzWtTDfv1OidsmplJzaJ6dWy497kRzZweHiCHf3Dh1-qUJyKdTX67XaXNGrt-tP39QN_wu03JqC</recordid><startdate>201406</startdate><enddate>201406</enddate><creator>D'Incau, Paola</creator><creator>Lapeyre-Mestre, Maryse</creator><creator>Carvajal, Alfonso</creator><creator>Donati, Monia</creator><creator>Salado, Inés</creator><creator>Rodriguez, Lauriane</creator><creator>Sáinz, María</creator><creator>Escudero, Antonio</creator><creator>Conforti, Anita</creator><general>Blackwell Publishing Ltd</general><general>Blackwell</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>201406</creationdate><title>No differences between men and women in adverse drug reactions related to psychotropic drugs: a survey from France, Italy and Spain</title><author>D'Incau, Paola ; Lapeyre-Mestre, Maryse ; Carvajal, Alfonso ; Donati, Monia ; Salado, Inés ; Rodriguez, Lauriane ; Sáinz, María ; Escudero, Antonio ; Conforti, Anita</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-i3542-7605751c2f8f50c54fbf120718dab91a275a44f957f56d1439fefebcde627b123</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adverse Drug Reaction Reporting Systems</topic><topic>Biological and medical sciences</topic><topic>Chi-Square Distribution</topic><topic>Data Interpretation, Statistical</topic><topic>Drug-Related Side Effects and Adverse Reactions - epidemiology</topic><topic>Drug-Related Side Effects and Adverse Reactions - etiology</topic><topic>France - epidemiology</topic><topic>gender</topic><topic>Humans</topic><topic>Italy - epidemiology</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Pharmacology. Drug treatments</topic><topic>pharmacovigilance</topic><topic>Psychotropic Drugs - adverse effects</topic><topic>psychotropics</topic><topic>reporting</topic><topic>Sex Characteristics</topic><topic>Spain - epidemiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>D'Incau, Paola</creatorcontrib><creatorcontrib>Lapeyre-Mestre, Maryse</creatorcontrib><creatorcontrib>Carvajal, Alfonso</creatorcontrib><creatorcontrib>Donati, Monia</creatorcontrib><creatorcontrib>Salado, Inés</creatorcontrib><creatorcontrib>Rodriguez, Lauriane</creatorcontrib><creatorcontrib>Sáinz, María</creatorcontrib><creatorcontrib>Escudero, Antonio</creatorcontrib><creatorcontrib>Conforti, Anita</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>Fundamental & clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>D'Incau, Paola</au><au>Lapeyre-Mestre, Maryse</au><au>Carvajal, Alfonso</au><au>Donati, Monia</au><au>Salado, Inés</au><au>Rodriguez, Lauriane</au><au>Sáinz, María</au><au>Escudero, Antonio</au><au>Conforti, Anita</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>No differences between men and women in adverse drug reactions related to psychotropic drugs: a survey from France, Italy and Spain</atitle><jtitle>Fundamental & clinical pharmacology</jtitle><addtitle>Fundam Clin Pharmacol</addtitle><date>2014-06</date><risdate>2014</risdate><volume>28</volume><issue>3</issue><spage>342</spage><epage>348</epage><pages>342-348</pages><issn>0767-3981</issn><eissn>1472-8206</eissn><coden>FCPHEZ</coden><abstract>A large number of studies have suggested that being a woman represents a potential risk factor for the development of adverse drug reactions (ADRs). 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| ispartof | Fundamental & clinical pharmacology, 2014-06, Vol.28 (3), p.342-348 |
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| subjects | Adverse Drug Reaction Reporting Systems Biological and medical sciences Chi-Square Distribution Data Interpretation, Statistical Drug-Related Side Effects and Adverse Reactions - epidemiology Drug-Related Side Effects and Adverse Reactions - etiology France - epidemiology gender Humans Italy - epidemiology Male Medical sciences Pharmacology. Drug treatments pharmacovigilance Psychotropic Drugs - adverse effects psychotropics reporting Sex Characteristics Spain - epidemiology |
| title | No differences between men and women in adverse drug reactions related to psychotropic drugs: a survey from France, Italy and Spain |
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