{"id":32769,"date":"2020-03-25T00:00:00","date_gmt":"2020-03-25T00:00:00","guid":{"rendered":"http:\/\/medgoo.com\/index.php\/2020\/03\/25\/fda-issues-safety-alert-for-covid-19-risk-with-fecal-transplant\/"},"modified":"2020-03-26T16:10:06","modified_gmt":"2020-03-26T16:10:06","slug":"fda-issues-safety-alert-for-covid-19-risk-with-fecal-transplant","status":"publish","type":"post","link":"https:\/\/medgoo.com\/index.php\/2020\/03\/25\/fda-issues-safety-alert-for-covid-19-risk-with-fecal-transplant\/","title":{"rendered":"FDA Issues Safety Alert for COVID-19 Risk With Fecal Transplant"},"content":{"rendered":"<h3>Studies have recently shown SARS-CoV-2 present in stool of infected patients, suggesting transmission risk<\/h3>\n<p><b><\/b><\/p>\n<p><b><\/b><\/p>\n<p>WEDNESDAY, March 25, 2020 (HealthDay News) &#8212; The U.S. Food and Drug Administration issued a <i>MedWatch<\/i> Safety Alert on Tuesday about the potential risk for SARS-CoV-2 transmission with the use of fecal microbiota for transplantation (FMT) to treat <i>Clostridioides difficile<\/i> infection.<\/p>\n<p>Recent data have shown that SARS-CoV-2 RNA and\/or the SARS-CoV-2 virus is present in the stool of patients with the novel coronavirus (COVID-19), suggesting that SARS-CoV-2 could be transmitted by FMT. Testing of nasopharyngeal specimens from stool donors for SARS-CoV-2 is not widely available at this time, so information on the sensitivity of directly testing stool for SARS-CoV-2 is limited.<\/p>\n<p>The FDA directed health care workers to implement the following protections for any FMT with stool donated after Dec. 1, 2019: conduct donor screening to identify donors who may be or recently could have been infected with SARS-CoV-2; test donors and\/or donor stool for SARS-CoV-2; develop criteria for excluding donors and donor stool based on screening and testing; and obtain informed consent from patients regarding the potential for transmission of SARS-CoV-2 via FMT, including FMT prepared from the stool of donors who are asymptomatic for COVID-19.<\/p>\n<p>The FDA requests that any adverse events or side effects related to the use of FMT be reported to the MedWatch Safety Information and Adverse Event Reporting Program.<\/p>\n<p><a href=\"https:\/\/www.fda.gov\/safety\/medical-product-safety-information\/fecal-microbiota-transplantation-safety-alert-regarding-additional-safety-protections-pertaining\" target=\"_new\" rel=\"noopener noreferrer\">More Information<\/a><\/p>\n<p><i><\/i><\/p>\n<p><i><a href=\"https:\/\/www.healthday.com\/\" target=\"_new\" rel=\"noopener noreferrer\">Health News<\/a> Copyright \u00a9 2020 <a href=\"https:\/\/www.healthday.com\/\" target=\"_new\" rel=\"noopener noreferrer\">HealthDay<\/a>. All rights reserved.<\/i><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Studies have recently shown SARS-CoV-2 present in stool of infected patients, suggesting transmission risk<\/p>\n","protected":false},"author":6,"featured_media":32789,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[11],"class_list":["post-32769","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-news"],"_links":{"self":[{"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/posts\/32769","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/comments?post=32769"}],"version-history":[{"count":0,"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/posts\/32769\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/media\/32789"}],"wp:attachment":[{"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/media?parent=32769"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/categories?post=32769"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medgoo.com\/index.php\/wp-json\/wp\/v2\/tags?post=32769"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}