{"id":519910,"date":"2010-04-07T12:57:16","date_gmt":"2010-04-07T16:57:16","guid":{"rendered":"http:\/\/blogs.wsj.com\/health\/2010\/04\/07\/fda-issues-warning-letters-over-tysabri-lipodissolve-injections\/"},"modified":"2010-04-07T12:57:16","modified_gmt":"2010-04-07T16:57:16","slug":"fda-issues-warning-letters-over-tysabri-%e2%80%98lipodissolve%e2%80%99-injections","status":"publish","type":"post","link":"https:\/\/mereja.media\/index\/519910","title":{"rendered":"FDA Issues Warning Letters Over Tysabri, \u2018Lipodissolve\u2019 Injections"},"content":{"rendered":"<p><img decoding=\"async\" src=\"http:\/\/s.wsj.net\/media\/fda_D_20100122174936.jpg\" alt=\"FDA\" align=\"right\"\/>The FDA today disclosed several warning letters it had sent to drug makers and weight-loss spas for &#8220;false&#8221; and-or &#8220;misleading&#8221; claims for their products.  Here&#8217;s a rundown:<\/p>\n<ul>\n<li>Biogen Idec was cited for a promotional Webcast involving the multiple sclerosis drug Tysabri because it minimized the risk of a serious brain infection, the FDA said. <a href=\"http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/EnforcementActivitiesbyFDA\/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies\/UCM207686.pdf\" >The letter<\/a> also cited the company for failing to submit the Webcast for FDA review 30 days in advance. Tysabri is sold jointly by Biogen and Elan.<\/li>\n<li>Gilead Sciences was cited for a print ad for involving its HIV drug Truvada, which the <a href=\"http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/EnforcementActivitiesbyFDA\/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies\/UCM207683.pdf\" >FDA said<\/a> overstated the effectiveness of the products and minimized the risks associated with the<br \/>\ndrug.<\/li>\n<li>Half a dozen spas offering &#8220;lipodissolve&#8221; injections to get rid of small fat deposits <a href=\"http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm207453.htm\" >received letters<\/a> because the FDA said the therapy <a href=\"http:\/\/blogs.wsj.com\/health\/2009\/01\/06\/injected-fat-dissolver-shows-promise-in-human-tests\/\" >hasn&#8217;t been cleared<\/a> by regulators. &#8220;The claims made for your lipodissolve products are false and misleading in that they are not supported by substantial evidence or substantial clinical experience,&#8221; one letter said.<\/li>\n<\/ul>\n<p><strong>Update:<\/strong> A Biogen spokeswoman told Dow Jones Newswires that the company believed &#8220;the content and means for communicating this safety information was appropriate, timely, factual and non-promotional, and we plan to have further conversation with the agency.&#8221;  Gilead said in a statement that takes the FDA&#8217;s concerns regarding the advertisements seriously &#8220;and we will be working to respond to the FDA promptly,&#8221; according to DJ Newswires.<\/p>\n<p><a href=\"http:\/\/feedads.g.doubleclick.net\/~at\/X53Q7-BouvzNb8euoDV67VHyMTo\/0\/da\"><img decoding=\"async\" src=\"http:\/\/feedads.g.doubleclick.net\/~at\/X53Q7-BouvzNb8euoDV67VHyMTo\/0\/di\" border=\"0\" ismap=\"true\"><\/img><\/a><br \/>\n<a href=\"http:\/\/feedads.g.doubleclick.net\/~at\/X53Q7-BouvzNb8euoDV67VHyMTo\/1\/da\"><img decoding=\"async\" src=\"http:\/\/feedads.g.doubleclick.net\/~at\/X53Q7-BouvzNb8euoDV67VHyMTo\/1\/di\" border=\"0\" ismap=\"true\"><\/img><\/a><\/p>\n<div class=\"feedflare\">\n<a href=\"http:\/\/feeds.feedburner.com\/~ff\/wsj\/health\/feed?a=r744PA5ozbE:ztdy7qvazcQ:yIl2AUoC8zA\"><img decoding=\"async\" src=\"http:\/\/feeds.feedburner.com\/~ff\/wsj\/health\/feed?d=yIl2AUoC8zA\" border=\"0\"><\/img><\/a> <a href=\"http:\/\/feeds.feedburner.com\/~ff\/wsj\/health\/feed?a=r744PA5ozbE:ztdy7qvazcQ:D7DqB2pKExk\"><img decoding=\"async\" src=\"http:\/\/feeds.feedburner.com\/~ff\/wsj\/health\/feed?i=r744PA5ozbE:ztdy7qvazcQ:D7DqB2pKExk\" border=\"0\"><\/img><\/a> <a href=\"http:\/\/feeds.feedburner.com\/~ff\/wsj\/health\/feed?a=r744PA5ozbE:ztdy7qvazcQ:F7zBnMyn0Lo\"><img decoding=\"async\" src=\"http:\/\/feeds.feedburner.com\/~ff\/wsj\/health\/feed?i=r744PA5ozbE:ztdy7qvazcQ:F7zBnMyn0Lo\" border=\"0\"><\/img><\/a> <a href=\"http:\/\/feeds.feedburner.com\/~ff\/wsj\/health\/feed?a=r744PA5ozbE:ztdy7qvazcQ:V_sGLiPBpWU\"><img decoding=\"async\" src=\"http:\/\/feeds.feedburner.com\/~ff\/wsj\/health\/feed?i=r744PA5ozbE:ztdy7qvazcQ:V_sGLiPBpWU\" border=\"0\"><\/img><\/a> <a href=\"http:\/\/feeds.feedburner.com\/~ff\/wsj\/health\/feed?a=r744PA5ozbE:ztdy7qvazcQ:qj6IDK7rITs\"><img decoding=\"async\" src=\"http:\/\/feeds.feedburner.com\/~ff\/wsj\/health\/feed?d=qj6IDK7rITs\" border=\"0\"><\/img><\/a>\n<\/div>\n<p><img loading=\"lazy\" decoding=\"async\" src=\"http:\/\/feeds.feedburner.com\/~r\/wsj\/health\/feed\/~4\/r744PA5ozbE\" height=\"1\" width=\"1\"\/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA today disclosed several warning letters it had sent to drug makers and weight-loss spas for &#8220;false&#8221; and-or &#8220;misleading&#8221; claims for their products. Here&#8217;s a rundown: Biogen Idec was cited for a promotional Webcast involving the multiple sclerosis drug Tysabri because it minimized the risk of a serious brain infection, the FDA said. The [&hellip;]<\/p>\n","protected":false},"author":792,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-519910","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/519910","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/users\/792"}],"replies":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/comments?post=519910"}],"version-history":[{"count":0,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/519910\/revisions"}],"wp:attachment":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/media?parent=519910"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/categories?post=519910"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/tags?post=519910"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}