{"id":2081224,"date":"2023-10-27T11:24:04","date_gmt":"2023-10-27T15:24:04","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fda-issues-warning-on-probiotics-after-baby-dies\/"},"modified":"2023-10-27T11:28:17","modified_gmt":"2023-10-27T15:28:17","slug":"fda-issues-warning-on-probiotics-after-baby-dies","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fda-issues-warning-on-probiotics-after-baby-dies\/","title":{"rendered":"FDA warns about probiotics after infant death"},"content":{"rendered":"<aside class=\"mashsb-container mashsb-main mashsb-stretched\"><div class=\"mashsb-box\"><div class=\"mashsb-count mash-medium\" style=\"&quot;\"><div class=\"counts mashsbcount\">14<\/div><span class=\"mashsb-sharetext\">SHARES<\/span><\/div><div class=\"mashsb-buttons\"><a class=\"mashicon-facebook mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fwww.conservativenewsdaily.net%2Fbreaking-news%2Ffda-issues-warning-on-probiotics-after-baby-dies%2F\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Facebook<\/span><\/a><a class=\"mashicon-twitter mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/twitter.com\/intent\/tweet?text=&amp;url=https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=2081224&amp;via=ConservNewsDly\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Twitter<\/span><\/a><a class=\"mashicon-subscribe mash-medium mash-nomargin mashsb-noshadow\" href=\"#\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Subscribe<\/span><\/a><div class=\"onoffswitch2 mash-medium mashsb-noshadow\" style=\"display:none\"><\/div><\/div>\n            <\/div>\n                <div style=\"clear:both\"><\/div><\/aside>\n            <!-- Share buttons by mashshare.net - Version: 4.0.47--><blockquote>\n<h2>The FDA\u2063 Warns of Fatal Health Risks Associated\u2063 with\u2062 Probiotics for Preterm Infants<\/h2>\n<p>The U.S. Food and Drug Administration (FDA) \u2063issued a warning on Thursday, cautioning that probiotics\u200d for preterm infants could have potentially deadly \u200dconsequences. \u200dThe agency revealed that \u2064one\u2064 infant death \u200bearlier \u2063this year was linked \u2062to probiotic products, and since 2018, over two <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fda-issues-warning-on-probiotics-after-baby-dies\/\" title=\"FDA warns about probiotics after infant death\">dozen adverse incidents involving infants<\/a>\u200d have been associated with these products. The FDA \u200cis \u2063currently investigating additional cases.<\/p>\n<p>In \u200da \u2063news release, the \u2064health regulator explained\u2064 that \u200bprobiotic products,\u200b which contain live organisms like bacteria or yeast,\u200d are commonly marketed as foods and dietary supplements. However, the FDA has \u200bnot approved any \u200bprobiotics for \u200binfants \u2063of any age. Despite \u2062this, \u200csome hospitals have been using probiotics to treat certain\u200c diseases in preterm infants.<\/p>\n<h3>Related Stories<\/h3>\n<ul>\n<li><a href=\"http:\/\/www.theepochtimes.com\/article\/senator-demands-answers-from-fda-on-safety-signal-for-covid-vaccines-and-children-5517398?ea_src=author_manual&#038;ea_med=related_stories\"><strong>Senator\u2064 Demands Answers From\u2063 FDA on Safety\u200b Signal for\u200c COVID Vaccines and\u2064 Children<\/strong><\/a>  &#8211; 10\/26\/2023<\/li>\n<li><a href=\"http:\/\/www.theepochtimes.com\/health\/fda-should-recall-adulterated-pfizer-covid-19-vaccine-robert-malone-5515981?ea_src=author_manual&#038;ea_med=related_stories\"><strong>FDA Should \u200cRecall &#8216;Adulterated&#8217; Pfizer COVID-19\u200c Vaccine: Robert Malone<\/strong><\/a>  \u2063- 10\/25\/2023<\/li>\n<\/ul>\n<p>The FDA emphasized\u2064 that these probiotic products\u2064 can be dangerous for preterm infants and are being illegally sold as treatments \u200bor preventatives \u200cfor \u2063diseases. The live bacteria or yeast contained in the probiotics can put \u2064these\u200b infants\u2064 at\u200c risk of invasive and potentially fatal diseases or\u2063 infections.<\/p>\n<p>The FDA also issued a warning letter to a\u200c company that sells probiotic products for use in \u2062hospital settings for preterm infants. The agency stated that based on the company&#8217;s\u200c intended \u2064uses and \u200cmarketing materials, \u2064the product \u2062is\u2063 an unapproved new drug and an unlicensed biological \u200cproduct, <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/actblue-facilitating-donations-to-terror-tied-charity-legal-group-says\/\" title=\"ActBlue Facilitating Donations to Terror-Tied Charity, Legal Group Says\">violating federal laws<\/a>.<\/p>\n<p>One incident mentioned in the\u200d notice involved a preterm infant who developed sepsis after being given a probiotic product called Evivo with MCT Oil, manufactured by \u200dInfinant Health. Sepsis\u200d is a <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fda-lifts-restriction-on-remote-prescriptions-of-abortion-drugs\/\" title=\"FDA Lifts Restriction on Remote Prescriptions of Abortion Drugs\">life-threatening condition<\/a> that occurs when \u2064an infection spreads throughout the body, causing organ failure\u200b and \u2062tissue damage. The specific hospital where the\u2064 probiotic was administered and further details about the incident were not provided.<\/p>\n<p>Dr. Peter Marks, a top FDA official, emphasized the serious risks that \u2062live microorganism-containing products pose to preterm\u2062 infants in hospital settings. He urged parents, caregivers, and healthcare providers to exercise caution when using these\u200d products for disease \u2063prevention or treatment, as\u200c they \u2064have not undergone the FDA&#8217;s rigorous evaluation for safety and effectiveness.<\/p>\n<div class=\"post-figure\">\n<figure style=\"width:600px\" class=\"alignnone\"><figcaption>A\u2062 woman shops for yogurt,\u200d a \u2063food\u200d commonly associated with good \u2064gut bacteria known as probiotics.\u2063 (Olga Maltseva\/AFP\/Getty Images)<\/figcaption><\/figure>\n<\/div>\n<p>The American \u2063Academy of Pediatrics has\u200c issued guidelines stating that\u2063 current evidence does not support the routine administration of probiotics\u200b to preterm infants, particularly those with a birth\u200c weight of less than 2.2 pounds.\u200d However, a recent\u2063 survey published in JAMA Pediatrics found that probiotics with multiple strains of bacteria \u200ccan <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/florida-senate-republicans-advance-bill-to-prohibit-abortion-of-babies-after-15-weeks-gestation\/\" title=\"Florida Senate Republicans Advance Bill to Prohibit Abortion of Babies After 15 Weeks Gestation\">reduce infant mortality<\/a> and inflammation of \u200cthe \u2062intestines caused by necrotizing enterocolitis.<\/p>\n<p>Probiotics, which are beneficial bacteria found in \u200cyogurt, kefir, and supplements, are consumed for their health benefits. Infinant Health, the manufacturer of Evivo with MCT Oil, has \u200bstated that\u2063 their product contains only one strain \u200cof bacteria. \u2063The company has agreed to cooperate with the FDA&#8217;s investigation and has halted the distribution of \u2062the product.<\/p>\n<p>In a statement, Abbott, a major infant\u200c formula manufacturer, clarified that the \u200bFDA&#8217;s warning does\u2062 not apply to\u2063 their \u200dretail\u2064 infant formula products. They assured parents \u200dand caregivers that Similac infant formulas remain safe for use.<\/p>\n<p>In September, the \u2063FDA \u2064issued\u200c a\u2063 public warning to Infinant Health, describing Evivo with MCT Oil as\u200c an unapproved new drug\u2063 and unlicensed biological product.<\/p>\n<p>The \u200dFDA highlighted the vulnerability \u200dof preterm infants due to their immature gastrointestinal systems, which can lead to \u2063infections and sepsis when\u200b exposed to living microorganisms.\u200c The agency\u2063 emphasized that the\u200b current\u2063 literature \u200bdoes not\u2062 provide \u2062a consensus \u2062on \u2062the safety \u2062of using live microorganisms in preterm infants.<\/p>\n<\/blockquote>\n<p> <\/p>\n<h2> Why does the FDA recommend consulting with medical professionals before\u2064 administering probiotics to preterm infants?<\/h2>\n<p><span>  Roducts and to consult with medical professionals before administering any probiotics to preterm infants. The FDA recommends that healthcare \u2064providers obtain clear and accurate information\u200c about the \u2064products they use and\u200c ensure they are safe and effective.<\/p>\n<p>The warning from the FDA serves as a\u200c reminder of\u2062 the \u200dimportance of thorough research and regulation\u200b when it comes to healthcare products, particularly those meant for vulnerable populations like preterm infants. The potential dangers of using unapproved or unlicensed\u200d products cannot be taken lightly, as they \u200ccan have severe consequences for the \u2062health \u200cand well-being of these \u2064infants.<\/p>\n<p>It is crucial for medical professionals to have access to accurate information and guidelines to ensure the safety and\u200b proper treatment of preterm infants. The FDA plays a vital role in monitoring and regulating healthcare products to protect the public and prevent harm. This incident serves as a call for stricter regulations and oversight in the \u200cproduction\u2063 and marketing of probiotics and other healthcare products.<\/p>\n<p>Parents and caregivers should also be cautious and informed when it comes to choosing and using healthcare products for\u200b their infants. Consulting with healthcare providers and conducting thorough research can help ensure that the products used are safe and appropriate for\u2064 preterm infants.<\/p>\n<p>In conclusion, the recent warning from the \u200dFDA regarding the potential fatal health risks associated with probiotics \u200bfor preterm infants highlights the need for strict regulation and\u200c careful\u200d consideration when it\u200c comes to healthcare products. Medical professionals, parents,\u2062 and caregivers must exercise caution and <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/child-tax-credit-payment-worth-330-per-child-to-be-sent-to-new-york-families-in-2024\/\" title=\"0 per child to be sent to New York families in 2024 as Child Tax Credit payment.\">seek expert advice<\/a> to ensure the safety and well-being \u2064of preterm infants. The FDA&#8217;s investigation and warnings serve as a reminder of the importance of \u200dthorough research, regulation, and oversight in the healthcare industry to prevent potential\u200d harm to \u2062vulnerable populations.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA has cautioned that probiotics for preterm infants may pose fatal health risks. One infant death earlier this year was associated with these products. Since 2018, over two dozen adverse incidents involving infants have been linked to probiotics, according to the agency&#8217;s warning.<\/p>\n","protected":false},"author":58,"featured_media":2081225,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","fifu_image_alt":"","footnotes":""},"categories":[543],"tags":[],"class_list":["post-2081224","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-the-epoch-times"],"fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","_links":{"self":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2081224","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/users\/58"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=2081224"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2081224\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/2081225"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=2081224"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=2081224"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=2081224"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}