{"id":2042,"date":"2011-10-26T15:56:28","date_gmt":"2011-10-26T19:56:28","guid":{"rendered":"http:\/\/blogs.nejm.org\/?p=2042"},"modified":"2015-06-04T15:15:37","modified_gmt":"2015-06-04T19:15:37","slug":"xigris-is-gone-not-that-many-id-docs-will-notice","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/xigris-is-gone-not-that-many-id-docs-will-notice\/2011\/10\/26\/","title":{"rendered":"Xigris is Gone &#8212; Not That Many ID Docs Will Notice"},"content":{"rendered":"<p>From the FDA comes <a href=\"http:\/\/www.fda.gov\/Safety\/MedWatch\/SafetyInformation\/SafetyAlertsforHumanMedicalProducts\/ucm277143.htm\" target=\"_blank\">this news:<\/a><\/p>\n<blockquote><p>FDA notified healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris [drotrecogin alfa (activated)]. In a recently completed clinical trial (PROWESS-SHOCK trial), Xigris failed to show a survival benefit for patients with severe sepsis and septic shock.<\/p><\/blockquote>\n<p>Some quick (and non-scientific) thoughts on these perhaps no-so-surprising turn of events:<\/p>\n<ul>\n<li><a href=\"http:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2011\/10\/xigris-beta1.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignright size-full wp-image-2049\" title=\"xigris beta\" src=\"http:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2011\/10\/xigris-beta1.jpg\" alt=\"\" width=\"280\" height=\"241\" \/><\/a>The use of various adjunctive therapies in acute sepsis has a long and mostly checkered history. ACTH-directed glucocorticoids, mineralocorticoids, intensive insulin therapy, disparate\u00a0<a href=\"http:\/\/www2.cochrane.org\/reviews\/en\/ab001090.html\" target=\"_blank\">antibody treatments<\/a> (most famously <a href=\"http:\/\/www.annals.org\/content\/121\/1\/1.abstract\" target=\"_blank\">anti-endotoxin antibodies<\/a>) &#8212; none has really worked very well. Now we can add recombinant human activated protein C &#8212; Xigris &#8212; to the list of disappointing (and sometimes dangerous) therapies. In failure there may be opportunity, but treatment of sepsis is one tough nut to crack.<\/li>\n<li>I know trade names are frowned upon in academic medicine, but is there anyone who actually said, &#8220;drotrecogin alpha (activated)&#8221;? What kind of word is &#8220;drotrecogin&#8221;? Is there a &#8220;Drotrecogin Beta (Activated),&#8221; and is it a space ship? The use of the parenthetical post-name word &#8212; &#8220;(activated)&#8221; &#8212; is particularly cumbersome.<\/li>\n<li>Finally, how many ID doctors ever literally prescribed this drug? In our institution, the use of drotecogin alpha &#8230; oh you know, <em>Xigris<\/em> &#8230; was overwhelmingly in the hands of the intensivists. They would consult us sometimes after giving it to their critically-ill patients for advice on the usual ID issues (choice of antibiotics, source of fever, whether to change the lines). I only remember being specifically asked, &#8220;should we give it&#8221; a few times, and am certain I never ordered it.<\/li>\n<\/ul>\n<p>Meanwhile, &#8220;Xigris&#8221; happens to be a terrific name. Kudos to whatever advertising brainiac thought of that one.<\/p>\n<p>I&#8217;m sure he\/she cashed the check for these services many years ago.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>From the FDA comes this news: FDA notified healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris [drotrecogin alfa (activated)]. In a recently completed clinical trial (PROWESS-SHOCK trial), Xigris failed to show a survival benefit for patients with severe sepsis and septic [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,5,9],"tags":[847,999],"class_list":["post-2042","post","type-post","status-publish","format-standard","hentry","category-health-care","category-infectious-diseases","category-policy","tag-sepsis","tag-xigris"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/2042","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/comments?post=2042"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/2042\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/media?parent=2042"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/categories?post=2042"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/tags?post=2042"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}