{"id":2279,"date":"2007-09-03T16:22:57","date_gmt":"2007-09-03T15:22:57","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=2279"},"modified":"2013-09-12T16:39:43","modified_gmt":"2013-09-12T16:39:43","slug":"pfizer-issue-dear-doctor-letter-over-ems-content-in-us-formulation-of-nelfinavir","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/2279","title":{"rendered":"Pfizer issue Dear Doctor letter over EMS content in US formulation of nelfinavir"},"content":{"rendered":"<p><strong>Following the EMS contamination of nelfinavir manufactured by Roche, the FDA required Pfizer, who manufacture and market nelfinavir in the US, to carry out a similar safety analysis.<\/strong><\/p>\n<p>They reported that the levels of EMS detected in Pfizer\u0092s nelfinavir were much lower than in the contaminated nelfinavir manufactured by Roche.<\/p>\n<p>The FDA and Pfizer have agreed to specific limits of exposure of EMS to allow for continued use in populations where the benefit of using Viracept outweighs the potential risk.<\/p>\n<p>At this time, FDA and Pfizer consider the risks of unintended interruption of HIV treatment that may result from a recall to be greater than the risks associated with taking Pfizer manufactured Viracept.<\/p>\n<p>On 10 September 2007,Pfizer is issued a Dear Healthcare Professional letter to describe the current situation:<\/p>\n<p><a href=\"http:\/\/www.pfizer.com\/files\/products\/viracept_letter_9_10_2007.pdf\">http:\/\/www.pfizer.com\/files\/products\/viracept_letter_9_10_2007.pdf<\/a><\/p>\n<p>Source: FDA list serve<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Following the EMS contamination of nelfinavir manufactured by Roche, the FDA required Pfizer, who manufacture and market nelfinavir in the US, to carry out a similar safety analysis. They reported that the levels of EMS detected in Pfizer\u0092s nelfinavir were &hellip;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[40],"tags":[],"class_list":["post-2279","post","type-post","status-publish","format-standard","hentry","category-treatment-alerts"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/2279","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=2279"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/2279\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=2279"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=2279"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=2279"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}