{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,4]],"date-time":"2026-10-04T02:55:31Z","timestamp":1791082531312,"version":"4.1.0"},"reference-count":34,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2012,9,27]],"date-time":"2012-09-27T00:00:00Z","timestamp":1348704000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accpjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacotherapy"],"published-print":{"date-parts":[[2012,11]]},"abstract":"<jats:sec>\n                    <jats:title>Study Objective<\/jats:title>\n                    <jats:p>As data that prompted a 2009 labeling change detailing contraindications, precautions, and dosing recommendations for the first branded colchicine product were limited to case reports of myotoxicity and blood dyscrasias ascribed to the drug, we sought to quantify the association of colchicine therapy with serious adverse outcomes in a cohort of insured patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Case\u2010control study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Source<\/jats:title>\n                    <jats:p>Kaiser Permanente Colorado electronic data warehouses and electronic medical records.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients<\/jats:title>\n                    <jats:p>\n                      Cases were patients with a creatine kinase (\n                      <jats:styled-content style=\"fixed-case\">CK<\/jats:styled-content>\n                      ) level of at least 2000 U\/L or who developed a clinically significant non\u2013cancer\u2010related blood dyscrasia (thrombocytopenia, neutropenia, leukopenia, aplastic anemia, or pancytopenia) between\n                      <jats:styled-content style=\"fixed-case\">J<\/jats:styled-content>\n                      anuary 1, 2006, and\n                      <jats:styled-content style=\"fixed-case\">J<\/jats:styled-content>\n                      une 30, 2009 (954 cases). Each case was matched to up to 10 controls by age, sex, and index date (date of the increased\n                      <jats:styled-content style=\"fixed-case\">CK<\/jats:styled-content>\n                      level or blood dyscrasia\u2013supporting laboratory value). Controls were patients without elevated\n                      <jats:styled-content style=\"fixed-case\">CK<\/jats:styled-content>\n                      levels or blood dyscrasias who had a routine health maintenance examination during the same time period (index date was the date of their health maintenance examination [9007 controls]).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Measurements and Main Results<\/jats:title>\n                    <jats:p>\n                      The primary study outcome was colchicine exposure, defined as a colchicine prescription purchase in the 100\u00a0days before the index date. The likelihood of colchicine exposure was examined with conditional logistic regression. Cases experienced a higher rate of previous colchicine exposure compared with controls (0.6% vs 0.2%, odds\n                      <jats:styled-content style=\"fixed-case\">r<\/jats:styled-content>\n                      atio 3.9, 95% confidence interval 1.4\u201310.7). In addition, cases had higher hospitalization rates (14.9% vs 5.0%, p&lt;0.001), higher mean chronic disease scores (2.5 vs 0.0, p&lt;0.001), and were more likely to have been exposed to drugs that may increase the risk of adverse events due to an interaction with a CYP3A4 inhibitor drug (6.9% vs 2.3%, p&lt;0.001).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      Patients with confirmed elevations in\n                      <jats:styled-content style=\"fixed-case\">CK<\/jats:styled-content>\n                      level and\/or blood dyscrasias had a higher rate of previous colchicine exposure, although low overall, and greater hospitalization rates and exposure to drugs that may increase the risk of adverse events compared with controls. These findings support the 2009 United States Food and Drug Administration labeling for the first branded colchicine product, cautioning use in patients with liver impairment or renal dysfunction and\/or those receiving concurrent drugs that may increase risk of adverse events.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/phar.1125","type":"journal-article","created":{"date-parts":[[2012,9,27]],"date-time":"2012-09-27T17:44:58Z","timestamp":1348767898000},"page":"974-980","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Assessment of the Association Between Colchicine Therapy and Serious Adverse Events"],"prefix":"10.1002","volume":"32","author":[{"given":"Brittany A.","family":"Todd","sequence":"first","affiliation":[{"name":"Kaiser Permanente Colorado Aurora Colorado"},{"name":"University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences Aurora 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