{"id":6895,"date":"2002-11-13T13:57:40","date_gmt":"2002-11-13T12:57:40","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=6895"},"modified":"2014-06-03T17:34:38","modified_gmt":"2014-06-03T17:34:38","slug":"new-safety-information-for-ddi-used-with-ribavirin","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/6895","title":{"rendered":"New safety information for ddI used with ribavirin"},"content":{"rendered":"<p><strong>The ddI (didanosine, Videx) label has been revised to include new, precautionary information about co-administration of VIDEX and ribavirin (RBV) in HIV\/HCV co-infected patients.<\/strong><\/p>\n<p>Literature reports [1, 2] and 24 cases submitted to the FDA Adverse Event Reporting System (AERS) were reviewed to examine cases of patients receiving ddI who added treatment with ribavirin. There appeared to be a relationship between the time that ribavirin was initiated and the occurrence of toxicity, on average 4.8 months.<\/p>\n<p>In vitro data demonstrating that RBV increases the levels of the active ddI metabolite, dideoxyadenosine 5\u2019-triphosphate (ddATP), and clinical reports suggesting the potential for didanosine-related toxicities led to the addition of new precautionary language in the ddI label. The following has been added to the \u201cPrecautions\u201d section of the label:<\/p>\n<p>\u201cExposure to didanosine or its active metabolite (dideoxyadenosine 5\u2019-triphosphate) is increased when didanosine is co-administered with ribavirin. Increased exposure may cause or worsen didanosine-related clinical toxicities, including pancreatitis, symptomatic hyperlactatemia\/lactic acidosis, and peripheral neuropathy. Co-administration of ribavirin with Videx should be undertaken with caution, and patients should be monitored closely for didanosine-related toxicities. Videx should be suspended if signs or symptoms of pancreatitis, symptomatic hyperlactatemia, or lactic acidosis develop.\u201d<\/p>\n<p>References:<\/p>\n<ol>\n<li>Lafeuillade A, Hittinger G, Chadapaud S. Increased mitochondrial toxicity with ribavirin in HIV\/HCV coinfection. The Lancet, Vol 357, Jan 27, 2001.<br \/>\n<a href=\"http:\/\/www.ncbi.nlm.nih.gov\/entrez\/query.fcgi?cmd=%20Retrieve&amp;db=PubMed&amp;list_uids=11214134&amp;dopt=Abstract\">http:\/\/www.ncbi.nlm.nih.gov:80\/entrez\/query.fcgi?cmd= Retrieve&amp;db=PubMed&amp;list_uids=11214134&amp;dopt=Abstract<\/a><\/li>\n<li>Salmon-Ceron D, Chauvelot-Moachon L, Abad S, et al. Mitochondrial toxic effects and ribavirin. The Lancet, Vol 357, June 2, 2001.<br \/>\n<a href=\"http:\/\/www.ncbi.nlm.nih.gov\/entrez\/query.fcgi?cmd=%20Retrieve&amp;db=PubMed&amp;list_uids=11407389&amp;dopt=Abstract\">http:\/\/www.ncbi.nlm.nih.gov:80\/entrez\/query.fcgi?cmd=Retrieve&amp;db=PubMed&amp;list_uids=11407389&amp;dopt=Abstract<\/a><\/li>\n<\/ol>\n<p>This document was provided by the US Food and Drug Administration.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ddI (didanosine, Videx) label has been revised to include new, precautionary information about co-administration of VIDEX and ribavirin (RBV) in HIV\/HCV co-infected patients. Literature reports [1, 2] and 24 cases submitted to the FDA Adverse Event Reporting System (AERS) &hellip;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[40,3],"tags":[],"class_list":["post-6895","post","type-post","status-publish","format-standard","hentry","category-treatment-alerts","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/6895","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=6895"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/6895\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=6895"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=6895"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=6895"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}