{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T05:28:38Z","timestamp":1791264518956,"version":"4.1.0"},"reference-count":38,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2013,8,6]],"date-time":"2013-08-06T00:00:00Z","timestamp":1375747200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cephalalgia"],"published-print":{"date-parts":[[2014,1]]},"abstract":"<jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>The aim of this article is to investigate the vascular safety profile of triptans through an analysis of the United States Food and Drug Administration Adverse Event Reporting System (FDA_AERS) database with a special focus on serious and unexpected adverse events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A case\/non-case analysis was performed on the reports entered in the FDA_AERS from 2004 to 2010: Cases were reports with at least one event included in the MedDRA system organ classes \u2018Cardiac disorder\u2019 or \u2018Vascular disorders\u2019, whereas non-cases were all the remaining reports. Co-reported cardiovascular drugs were used as a proxy of cardiovascular risk and the adjusted reporting odds ratio (adj.ROR) with 95% confidence intervals (95% CI) was calculated. Disproportionality signals were defined as adj.ROR value &gt;1. Adverse events were considered unexpected if not mentioned on the relevant label.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 2,131,688 reports, 7808 concerned triptans. Cases were 2593 among triptans and 665,940 for all other drugs. Unexpected disproportionality signals were found in the following high-level terms of the MedDRA hierarchy: \u2018Cerebrovascular and spinal necrosis and vascular insufficiency\u2019 (103 triptan cases), \u2018Aneurysms and dissections non-site specific\u2019 (15), \u2018Pregnancy-associated hypertension\u2019 (10), \u2018Reproductive system necrosis and vascular insufficiency\u2019 (3).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>Our analysis revealed three main groups of unexpected associations between triptans and serious vascular events: ischaemic cerebrovascular events, aneurysms and artery dissections, and pregnancy-related vascular events. A case-by-case assessment is needed to confirm or disprove their plausibility and large-scale analytical studies should be planned for risk rate estimation. In the meantime, clinicians should pay special attention to migraine diagnosis and vascular risk assessment before prescribing a triptan, also promptly reporting any unexpected event to pharmacovigilance systems.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/0333102413499649","type":"journal-article","created":{"date-parts":[[2013,8,6]],"date-time":"2013-08-06T21:20:36Z","timestamp":1375824036000},"page":"5-13","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":46,"title":["Triptans and serious adverse vascular events: Data mining of the FDA Adverse Event Reporting System database"],"prefix":"10.1177","volume":"34","author":[{"given":"Giuseppe","family":"Roberto","sequence":"first","affiliation":[{"name":"Department of Medical and Surgical Sciences \u2013 Pharmacology Unit, University of Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo","family":"Piccinni","sequence":"additional","affiliation":[{"name":"Department of Medical and Surgical Sciences \u2013 Pharmacology Unit, University of Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"D\u2019Alessandro","sequence":"additional","affiliation":[{"name":"IRCCS \u2013 Istituto delle Scienze Neurologiche di Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabetta","family":"Poluzzi","sequence":"additional","affiliation":[{"name":"Department of Medical and Surgical Sciences \u2013 Pharmacology Unit, University of Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2013,8,6]]},"reference":[{"key":"bibr1-0333102413499649","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.a2329"},{"key":"bibr2-0333102413499649","doi-asserted-by":"crossref","first-page":"36S","DOI":"10.1016\/j.amjmed.2005.09.004","volume":"118","author":"Martin VT","year":"2005","journal-title":"Am J Med"},{"key":"bibr3-0333102413499649","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-200060060-00003"},{"key":"bibr4-0333102413499649","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2004.04078.x"},{"key":"bibr5-0333102413499649","unstructured":"GlaxoSmithKline. Imitrex (Sumatriptan succinate) \u2013 FDA prescribing information, http:\/\/www.accessdata.fda.gov\/spl\/data\/ba18a310-baaf-4663-a5b7-709b3320d0b2\/ba18a310-baaf-4663-a5b7-709b3320d0b2.xml (2011, accessed October 2012)."},{"key":"bibr6-0333102413499649","doi-asserted-by":"publisher","DOI":"10.1097\/MJT.0b013e3182258e2e"},{"key":"bibr7-0333102413499649","doi-asserted-by":"publisher","DOI":"10.3122\/jabfm.2010.01.090086"},{"key":"bibr8-0333102413499649","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.2010.522567"},{"key":"bibr9-0333102413499649","doi-asserted-by":"publisher","DOI":"10.1007\/s00246-004-0768-4"},{"key":"bibr10-0333102413499649","unstructured":"ForestLaboratoriesUKLimited. 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