{"id":2363,"date":"2019-08-15T00:20:17","date_gmt":"2019-08-14T16:20:17","guid":{"rendered":"https:\/\/esthersmusiccreations.com\/2019\/08\/15\/fda-suspends-clinical-trials-involving-fecal-transplants\/"},"modified":"2019-08-15T00:20:17","modified_gmt":"2019-08-14T16:20:17","slug":"fda-suspends-clinical-trials-involving-fecal-transplants","status":"publish","type":"post","link":"https:\/\/esthersmusiccreations.com\/en\/fda-suspends-clinical-trials-involving-fecal-transplants\/","title":{"rendered":"FDA Suspends Clinical Trials Involving Fecal Transplants"},"content":{"rendered":"<div class=\"text\">\n<h6 class=\"italic text-placeholder\">Jun 14, 2019 by CHIA-YI HOU<\/h6>\n<\/div>\n<h3>The agency issued a safety warning after two patients contracted antibiotic-resistant infections and one of the patients died.<\/h3>\n<p><main id=\"ArticleBody\" class=\"font-secondary fr-view\"><span class=\"dropcap\">T<\/span>he US Food and Drug Administration issued a safety alert for fecal transplant procedures after two immune-compromised patients contracted drug-resistant infections, according to a\u00a0<a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/safety-availability-biologics\/important-safety-alert-regarding-use-fecal-microbiota-transplantation-and-risk-serious-adverse\" target=\"_blank\" rel=\"noopener noreferrer\">statement from the agency\u2019s website<\/a>. The patients received transplants from the same donor, and one of the patients died. As a result, the agency plans to suspend clinical trials involving the procedure,\u00a0<em><a href=\"https:\/\/www.nytimes.com\/2019\/06\/13\/health\/fecal-transplant-fda.html\" target=\"_blank\" rel=\"noopener noreferrer\">The New York Times<\/a>\u00a0<\/em>reports.<\/p>\n<p>Fecal microbiota transplants (FMT) are not yet officially approved by the US Food and Drug Administration (FDA). \u201cWhile we support this area of scientific discovery, it\u2019s important to note that FMT does not come without risk,\u201d Peter Marks, director of the FDA\u2019s Center for Biologics Evaluation and Research, says in a\u00a0<a href=\"https:\/\/www.fda.gov\/news-events\/fda-brief\/fda-brief-fda-warns-about-potential-risk-serious-infections-caused-multi-drug-resistant-organisms\" target=\"_blank\" rel=\"noopener noreferrer\">brief statement on the agency\u2019s website<\/a>. Marks does not state how many clinical trials will be affected, but tells\u00a0<em>The Times\u00a0<\/em>it was \u201cnot just a few.\u201d<\/p>\n<p>The FDA warns that fecal matter should be tested for drug-resistant bacteria. \u201cToday\u2019s safety communication underscores the importance of why new therapies are thoroughly studied to ensure the benefits of taking them outweigh the risks to patients, and we will continue to aggressively monitor clinical trials to ensure patients are protected when safety concerns arise,\u201d Marks says in the statement.<\/p>\n<p><\/main><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Jun 14, 2019 by CHIA-YI HOU The agency issued a safety warning after two patients contracted antibiotic-resistant infections and one of the patients died. The US Food and Drug Administration issued a safety alert for [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":2360,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[54,37,49],"tags":[65,64,66],"jetpack_sharing_enabled":true,"jetpack_featured_media_url":"https:\/\/esthersmusiccreations.com\/wp-content\/uploads\/2019\/08\/P1000774-scaled.jpg","_links":{"self":[{"href":"https:\/\/esthersmusiccreations.com\/en\/wp-json\/wp\/v2\/posts\/2363"}],"collection":[{"href":"https:\/\/esthersmusiccreations.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/esthersmusiccreations.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/esthersmusiccreations.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/esthersmusiccreations.com\/en\/wp-json\/wp\/v2\/comments?post=2363"}],"version-history":[{"count":0,"href":"https:\/\/esthersmusiccreations.com\/en\/wp-json\/wp\/v2\/posts\/2363\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/esthersmusiccreations.com\/en\/wp-json\/wp\/v2\/media\/2360"}],"wp:attachment":[{"href":"https:\/\/esthersmusiccreations.com\/en\/wp-json\/wp\/v2\/media?parent=2363"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/esthersmusiccreations.com\/en\/wp-json\/wp\/v2\/categories?post=2363"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/esthersmusiccreations.com\/en\/wp-json\/wp\/v2\/tags?post=2363"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}