{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T10:10:47Z","timestamp":1789726247093,"version":"4.0.1"},"reference-count":53,"publisher":"SAGE Publications","issue":"10","license":[{"start":{"date-parts":[[2023,1,23]],"date-time":"2023-01-23T00:00:00Z","timestamp":1674432000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100000133","name":"Agency for Healthcare Research and Quality","doi-asserted-by":"publisher","award":["R01HS025984"],"award-info":[{"award-number":["R01HS025984"]}],"id":[{"id":"10.13039\/100000133","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Colchicine has a narrow therapeutic index. Its toxicity can be increased due to concomitant exposure to drugs inhibiting its metabolic pathway; these are cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To examine clinical outcomes associated with colchicine drug interactions using the spontaneous reports of the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>We conducted a disproportionality analysis using FAERS data from January 2004 through June 2020. The reporting odds ratio (ROR) and observed-to-expected ratio (O\/E) with shrinkage for adverse events related to colchicine\u2019s toxicity (ie, rhabdomyolysis\/myopathy, agranulocytosis, hemorrhage, acute renal failure, hepatic failure, arrhythmias, torsade de pointes\/QT prolongation, and cardiac failure) were compared between FAERS reports.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>A total of 787 reports included the combined mention of colchicine, an inhibitor of both CYP3A4 and P-gp drug, and an adverse event of interest. Among reports that indicated the severity, 61% mentioned hospitalization and 24% death. A total of 37 ROR and 34 O\/E safety signals involving colchicine and a CYP3A4\/P-gp inhibitor were identified. The strongest ROR signal was for colchicine + atazanavir and rhabdomyolysis\/myopathy (ROR = 35.4, 95% CI: 12.8-97.6), and the strongest O\/E signal was for colchicine + atazanavir and agranulocytosis (O\/E = 3.79, 95% credibility interval: 3.44-4.03).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion and Relevance:<\/jats:title>\n                    <jats:p>This study identifies numerous safety signals for colchicine and CYP3A4\/P-gp inhibitor drugs. Avoiding the interaction or monitoring for toxicity in patients when co-prescribing colchicine and these agents is highly recommended.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10600280221148031","type":"journal-article","created":{"date-parts":[[2023,1,23]],"date-time":"2023-01-23T04:46:15Z","timestamp":1674449175000},"page":"1137-1146","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":24,"title":["Drugs That Interact With Colchicine Via Inhibition of Cytochrome P450 3A4 and P-Glycoprotein: A Signal Detection Analysis Using a Database of Spontaneously Reported Adverse Events (FAERS)"],"prefix":"10.1177","volume":"57","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3916-0402","authenticated-orcid":false,"given":"Ainhoa","family":"G\u00f3mez-Lumbreras","sequence":"first","affiliation":[{"name":"Department of Pharmacotherapy, College of Pharmacy, The University of Utah, Salt Lake City, UT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard D.","family":"Boyce","sequence":"additional","affiliation":[{"name":"Department of Biomedical Informatics, University of Pittsburgh, Pittsburgh, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3821-4595","authenticated-orcid":false,"given":"Lorenzo","family":"Villa-Zapata","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Practice, College of Pharmacy, Mercer University, Atlanta, GA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Malinda S.","family":"Tan","sequence":"additional","affiliation":[{"name":"Department of Pharmacotherapy, College of Pharmacy, The University of Utah, Salt Lake City, UT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip D.","family":"Hansten","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, School of Pharmacy, University of Washington, Seattle, WA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Horn","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, School of Pharmacy, University of Washington, Seattle, WA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel C.","family":"Malone","sequence":"additional","affiliation":[{"name":"Department of Pharmacotherapy, College of Pharmacy, The University of Utah, Salt Lake City, UT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2023,1,23]]},"reference":[{"key":"bibr1-10600280221148031","volume-title":"Goodman & Gilman\u2019s: The Pharmacological Basis of Therapeutics","author":"Grosser T","edition":"13"},{"key":"bibr2-10600280221148031","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780130207"},{"key":"bibr3-10600280221148031","doi-asserted-by":"publisher","DOI":"10.1111\/j.1749-6632.2009.04674.x"},{"key":"bibr4-10600280221148031","doi-asserted-by":"publisher","DOI":"10.1136\/heartjnl-2015-308542"},{"key":"bibr5-10600280221148031","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.15896"},{"key":"bibr6-10600280221148031","doi-asserted-by":"publisher","DOI":"10.1248\/bpb.b20-00314"},{"key":"bibr7-10600280221148031","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2022.06.002"},{"key":"bibr8-10600280221148031","doi-asserted-by":"publisher","DOI":"10.3109\/15563650.2010.495348"},{"key":"bibr9-10600280221148031","doi-asserted-by":"publisher","DOI":"10.2459\/JCM.0000000000001157"},{"key":"bibr10-10600280221148031","doi-asserted-by":"publisher","DOI":"10.1186\/s13075-020-2120-7"},{"issue":"8","key":"bibr11-10600280221148031","first-page":"455","volume":"63","author":"Stromberg P","year":"2014","journal-title":"J Fam Pract"},{"issue":"4","key":"bibr12-10600280221148031","first-page":"515","volume":"19","author":"Akdag I","year":"2006","journal-title":"J Nephrol"},{"key":"bibr13-10600280221148031","doi-asserted-by":"publisher","DOI":"10.1097\/01.SMJ.0000163315.02563.B2"},{"key":"bibr14-10600280221148031","doi-asserted-by":"publisher","DOI":"10.1002\/art.30389"},{"key":"bibr15-10600280221148031","unstructured":"US Food & Drug Administration. 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