{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T06:06:01Z","timestamp":1788242761728,"version":"build-2803163510"},"reference-count":38,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2016,11,20]],"date-time":"2016-11-20T00:00:00Z","timestamp":1479600000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2017,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>To evaluate the association between the use of streptomycin, amikacin, kanamycin and capreomycin in tuberculosis (TB) treatment and the pharmacovigilance reporting of ototoxicity (deafness or hearing loss, tinnitus and vertigo). Second, to analyze patient demographic and geographic factors that influence the reporting of ototoxicity in TB treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A case\/non\u2010case disproportionality analysis of the VigiBase\u00ae individual case safety reports (ICSRs) of patients treated for TB using multidrug regimens that contain either of streptomycin, amikacin, kanamycin or capreomycin. Cases were reports of ototoxicity; non\u2010cases were other adverse drug reactions (ADRs). The unit of analysis was the drug\u2013ADR pair. We calculated reporting odds ratios (RORs) and their 95% confidence intervals (CI). The referent drug was streptomycin.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>By June 2014, there were 3361 drug\u2013ADR pairs in VigiBase\u00ae (1693 ICSRs) where the parenteral administration of the four drugs for TB treatment was suspected of causing the reported ADRs. Deafness, tinnitus and vertigo were reported in 576 drug\u2013ADR pairs (cases), the rest being other ADRs (non\u2010cases). Reporting of deafness was most disproportionately associated with amikacin use (ROR 9.3; 95%CI 3.8\u201323.0), followed by kanamycin use (ROR 4.3; 95%CI 1.3\u201314.2). Reporting of vertigo was inversely associated with capreomycin use (ROR 0.1; 95%CI 0.01\u20130.4). Geographic region affected the reporting of ototoxicity while age and sex did not.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Spontaneous reporting of deafness cases within VigiBase\u00ae was most disproportionately associated with amikacin use, followed by kanamycin. There were regional variations in the global reporting of ototoxicity. These findings should be verified through a follow up study. Copyright \u00a9 2016 John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.4125","type":"journal-article","created":{"date-parts":[[2016,11,21]],"date-time":"2016-11-21T03:12:38Z","timestamp":1479697958000},"page":"1-8","source":"Crossref","is-referenced-by-count":15,"title":["Differences in VigiBase\u00ae reporting of aminoglycoside and capreomycin\u2010suspected ototoxicity during tuberculosis treatment"],"prefix":"10.1002","volume":"26","author":[{"given":"Evans L.","family":"Sagwa","sequence":"first","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences Utrecht University  Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick C.","family":"Souverein","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences Utrecht University  Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"In\u00eas","family":"Ribeiro","sequence":"additional","affiliation":[{"name":"Centre for Health Technology Assessment and Drug Research Association for Innovation and Biomedical Research on Light and Image  Coimbra Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hubert G. M.","family":"Leufkens","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences Utrecht University  Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aukje K.","family":"Mantel\u2010Teeuwisse","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences Utrecht University  Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2016,11,20]]},"reference":[{"key":"e_1_2_9_2_1","volume-title":"Global Burden of Hearing Loss in the Year 2000","author":"Mathers C","year":"2001"},{"key":"e_1_2_9_3_1","first-page":"601","article-title":"Pharmacological drugs inducing ototoxicity, vestibular symptoms and tinnitus: a reasoned and updated guide","volume":"15","author":"Cianfrone G","year":"2011","journal-title":"Eur Rev Med Pharmacol Sci"},{"key":"e_1_2_9_4_1","unstructured":"KaplanW Wirtz.J. Veronika Mantel\u2010TeeuwisseAK Stolk P DutheyB LaingR.Priority Medicines for Europe and the World 2013 Update. Geneva Switzerland:2013."},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkh377"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(10)70139-0"},{"key":"e_1_2_9_7_1","unstructured":"World Health Organization (WHO).Guidelines for the programmatic management of drug\u2010resistant tuberculosis. Geneva Switzerland:2008."},{"key":"e_1_2_9_8_1","volume-title":"Drug\u2010Induced Hearing Loss\u2014Aminoglycosides","author":"Frymark T","year":"2010"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.3349\/ymj.2003.44.3.517"},{"key":"e_1_2_9_10_1","unstructured":"World Health Organization (WHO).Global Tuberculosis Report 2014. Geneva Switzerland:2014."},{"key":"e_1_2_9_11_1","unstructured":"World Health Organization (WHO).MDR\u2010TB 2014 update. Geneva Switzerland:2014."},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1177\/009286150804200501"},{"key":"e_1_2_9_13_1","unstructured":"Uppsala Monitoring Center.Uppsala Monitoring Centre (UMC) Website [Internet].2015[cited 2015 May 4];"},{"key":"e_1_2_9_14_1","unstructured":"Uppsala Monitoring Center.The WHO Adverse Reaction Terminology\u2014WHO\u2010ART [Internet].2014[cited 2014 Dec 15];5."},{"key":"e_1_2_9_15_1","unstructured":"ICH.Medical Dictionary for Regulatory Activities (MedDRA) [Internet].2015[cited 2015 May 4];"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1001"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-199716060-00002"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.668"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2011.04037.x"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1155\/2011\/937861"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.33.6.797"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.9.6.956"},{"key":"e_1_2_9_23_1","first-page":"905","article-title":"The incidence of amikacin ototoxicity in multidrug\u2010resistant tuberculosis patients","volume":"10","author":"Reza M","year":"2011","journal-title":"Iran J Pharm Res"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00044812"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6815-7-5"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40360-015-0036-7"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1086\/420742"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.4103\/0976-500X.120955"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-012-0014-6"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkr221"},{"key":"e_1_2_9_31_1","doi-asserted-by":"publisher","DOI":"10.1093\/bmb\/63.1.25"},{"key":"e_1_2_9_32_1","doi-asserted-by":"publisher","DOI":"10.1503\/cmaj.109-4199"},{"key":"e_1_2_9_33_1","volume-title":"Safety of Medicines in Sub\u2010Saharan Africa: Assessment of Pharmacovigilance Systems and their Performance","author":"Program SPS","year":"2011"},{"key":"e_1_2_9_34_1","doi-asserted-by":"publisher","DOI":"10.15171\/ijhpm.2015.55"},{"key":"e_1_2_9_35_1","doi-asserted-by":"publisher","DOI":"10.2165\/11536390-000000000-00000"},{"key":"e_1_2_9_36_1","doi-asserted-by":"publisher","DOI":"10.1136\/adc.2006.102889"},{"key":"e_1_2_9_37_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3018(16)00002-3"},{"key":"e_1_2_9_38_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1002"},{"key":"e_1_2_9_39_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2011.04087.x"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fpds.4125","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.4125","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,5]],"date-time":"2023-10-05T09:40:39Z","timestamp":1696498839000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.4125"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,11,20]]},"references-count":38,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2017,1]]}},"alternative-id":["10.1002\/pds.4125"],"URL":"https:\/\/doi.org\/10.1002\/pds.4125","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,11,20]]}}}