{"id":2048186,"date":"2023-09-28T14:55:02","date_gmt":"2023-09-28T18:55:02","guid":{"rendered":""},"modified":"2023-09-28T14:58:22","modified_gmt":"2023-09-28T18:58:22","slug":"fda-warns-of-possible-adverse-reaction-to-diabetes-drug-ozempic-updates-labels","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fda-warns-of-possible-adverse-reaction-to-diabetes-drug-ozempic-updates-labels\/","title":{"rendered":"FDA warns of potential side effects from diabetes drug Ozempic, updates labels."},"content":{"rendered":"<aside class=\"mashsb-container mashsb-main mashsb-stretched\"><div class=\"mashsb-box\"><div class=\"mashsb-count mash-medium\" style=\"float:left\"><div class=\"counts mashsbcount\">24<\/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-warns-of-possible-adverse-reaction-to-diabetes-drug-ozempic-updates-labels%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=2048186&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>Labels Updated for Diabetes \u200bDrug Ozempic to Include Intestinal Disorder<\/h2>\n<p>The FDA has recently updated the labels \u2062for the diabetes drug Ozempic to acknowledge\u2063 the occurrence\u200c of a condition that affects the normal\u200d functioning of the intestines in some users. This \u2064label update was made on September 22.<\/p>\n<p>The updated label now clearly states that a \u2064gastrointestinal disorder called ileus has been reported as\u200b an adverse reaction to the drug. Ileus is a temporary disruption of the normal muscle contractions in the intestines, which can result in improper food passage and waste movement through the body.<\/p>\n<h3>Related Stories<\/h3>\n<ul>\n<li>\n      <a href=\"http:\/\/www.theepochtimes.com\/article\/fda-found-bacterial-contamination-at-novo-nordisk-diabetes-pill-manufacturing-facility-5498640?ea_src=author_manual&#038;ea_med=related_stories\"><br \/>\n        <strong>FDA Found\u200b Bacterial\u200d Contamination at\u200d Novo Nordisk Diabetes Pill Manufacturing \u2062Facility<\/strong><br \/>\n      <\/a><br \/>\n      <span class=\"text-comp-caption\">9\/26\/2023<\/span>\n    <\/li>\n<li>\n      <a href=\"http:\/\/www.theepochtimes.com\/article\/cdc-fda-abrogating-their-duty-to-actually-protect-human-beings-dr-joseph-ladapo-5497999?ea_src=author_manual&#038;ea_med=related_stories\"><br \/>\n        <strong>CDC and FDA &#8216;Abrogating Their Duty to Actually Protect Human Beings\u2019: Dr. Ladapo<\/strong><br \/>\n      <\/a><br \/>\n      <span class=\"text-comp-caption\">9\/25\/2023<\/span>\n    <\/li>\n<\/ul>\n<p>The updated label also includes \u200da Disclaimer stating that due to the voluntary reporting of these reactions from an uncertain population size, it is difficult to estimate their \u200dfrequency or establish a direct\u200b link to the drug.<\/p>\n<p>Ileus is\u2063 more likely to occur in individuals who have undergone abdominal or pelvic surgery, have infections, or have certain muscle and nerve disorders like Parkinson&#8217;s\u2064 disease.<\/p>\n<p>Those taking medications that affect muscles and \u200bnerves,\u200d such as antidepressants \u2064and opioids, are also at a higher risk \u2063of developing this digestive disorder.<\/p>\n<p>Common symptoms of ileus include abdominal cramps, loss of appetite, constipation, vomiting, and an inability to pass bowel movements.<\/p>\n<div class=\"post-figure\">\n<figure style=\"width:1024px;margin-left:auto;margin-right:auto\" class=\"alignnone\"><figcaption>The anti-diabetic medication Ozempic (semaglutide) made by Danish\u2062 pharmaceutical company Novo Nordisk, in Paris on Feb. 23, 2023.\u2063 (Joel Sage\/AFP via Getty Images)<\/figcaption><\/figure>\n<\/p><\/div>\n<div class=\"my-5\">\n<h2>Ozempic\u2063 Popularity Soars<\/h2>\n<p>The label update comes\u2063 at a time when Ozempic, manufactured by Novo Nordisk, has <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/vivek-ramaswamy-makes-progress-on-closing-gap-with-ron-desantis-poll\/\" title=\"Vivek Ramaswamy narrows gap with Ron DeSantis: Poll shows progress.\">gained significant popularity<\/a> as an off-label weight loss aid. This surge in demand has led to widespread shortages of\u2062 the drug.<\/p>\n<\/p><\/div>\n<p>Ozempic works by stimulating insulin production and \u200creducing \u2064glucose production in the liver, <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fda-warns-of-possible-adverse-reaction-to-diabetes-drug-ozempic-updates-labels\/\" title=\"FDA warns of potential side effects from diabetes drug Ozempic, updates labels.\">effectively lowering blood\u200c sugar levels<\/a>.<\/p>\n<p>A similar diabetes drug \u200ccalled Mounjaro, made by Eli Lilly, suppresses\u200b appetite and reduces \u2062food intake by targeting the body&#8217;s receptors for the hormones GIP and GLP-1.<\/p>\n<p>Both Ozempic and Mounjaro have been named in a \u2064lawsuit filed by a woman in Louisiana. She claims\u2063 that\u200d the\u200d manufacturers failed to adequately warn users \u2062about the severe\u200d gastrointestinal problems these medications can cause, including gastroparesis, which is similar to ileus.<\/p>\n<p>The lawsuit\u2064 alleges that the manufacturers downplayed the severity of these gastrointestinal events\u2063 and did not warn about the risk of gastroparesis or gastroenteritis.<\/p>\n<div class=\"post-figure\">\n<figure style=\"width:600px\" class=\"alignnone\"><figcaption>The U.S. Food and Drug Administration (FDA) in White Oak, \u200cMd., on June 5, 2023. (Madalina Vasiliu\/The Epoch Times)<\/figcaption><\/figure>\n<\/p><\/div>\n<div class=\"my-5\">\n<h2>Semaglutide Adverse Reactions<\/h2>\n<p>The lawsuit highlights that both Novo Nordisk and Eli Lilly acknowledge gastrointestinal events as known side effects of the GLP-1 class of drugs. However, they\u2062 allegedly downplayed the severity of these events and failed to warn about\u200d the risk of gastroparesis and \u2062gastroenteritis.<\/p>\n<\/p><\/div>\n<p>Gastroparesis, which is also\u2063 caused by diabetes itself, is a condition characterized by\u2062 delayed stomach emptying.<\/p>\n<p>The lawsuit further claims that the manufacturers did not mention the risks of severe gastrointestinal events when they \u2063received FDA approval for these drugs.<\/p>\n<div class=\"my-5\">\n    <a href=\"https:\/\/www.theepochtimes.com\/health\/diabetes-drug-manufacturers-sued-by-woman-who-claims-she-suffered-severe-gastrointestinal-events-5441512\" target=\"_blank\" rel=\"noopener\">Lawyers for the woman<\/a> state that hundreds of other users have \u2063reported similar health issues and are considering legal action against the companies.<br \/>\n \u200b\n  <\/div>\n<p>According to\u2062 FDA data, there \u200bhave \u2063been 87 reports of adverse reactions related to semaglutide\u2063 medications, including Ozempic, this year alone. Since 2018, there have been over 400 reports, with approximately 250 of them being gastrointestinal disorders like ileus.<\/p>\n<div class=\"my-5\">\n<p>&#8220;Although ileus and gastroparesis\u2063 have some\u2064 similarities, they are not the\u2064 same,&#8221; said FDA spokeswoman Chanapa\u2062 Tantibanchachai in a <a href=\"https:\/\/www.cbsnews.com\/news\/ozempic-wegovy-possible-side-effect-blocked-intestines-fda-label\/\" target=\"_blank\" rel=\"noopener\">statement<\/a> to \u2062CBS News.<\/p>\n<p>Tantibanchachai added that while the labels for Ozempic and similar drugs \u2062already mention\u2062 &#8220;delayed \u2064gastric emptying&#8221; as a possible side effect, \u200dthe FDA is closely \u2063monitoring real-world reports of gastroparesis and related terms.<\/p>\n<p>The FDA will take appropriate action if any new\u200b safety concerns arise after\u200d a thorough review of available\u200c data.<\/p>\n<\/p><\/div>\n<p>The Epoch Times\u200d has reached\u200d out to the FDA for further comment.<\/p>\n<\/blockquote>\n<p> <\/p>\n<h2> What \u2062steps can regulatory agencies like the FDA take \u2062to strengthen\u2062 oversight and ensure thorough\u200d testing of drugs for potential adverse effects<\/h2>\n<p><span>  And Eli Lilly failed to adequately warn users about the potential adverse\u2064 reactions of their diabetes drugs. In addition to ileus and gastroparesis, \u2062other adverse reactions associated with semaglutide, the \u200cactive \u2064ingredient in Ozempic, include pancreatitis,\u2062 kidney \u200ddamage, thyroid cancer, \u2064and severe\u2062 allergic reactions.<\/p>\n<\/p><\/div>\n<p>The FDA&#8217;s label \u2063update for Ozempic is a step in the right direction towards ensuring that users are informed\u200b about\u2063 the potential risks and side effects of the drug.\u200c However, it is important for both manufacturers to take \u2063responsibility and provide clear and\u2063 accurate information about the risks associated\u2062 with their medications.<\/p>\n<p>Patients \u200dwho are taking Ozempic or similar drugs should be aware of the potential symptoms of ileus and other gastrointestinal disorders. If \u200cthey experience any of these symptoms,\u200b they should <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/do-this-monthly-and-you-may-slash-your-cancer-risk\/\" title=\"Do This Monthly and You May Slash Your Cancer Risk\">seek medical attention immediately<\/a>. \u2064It is also crucial for \u200chealthcare providers to\u200c monitor patients taking these\u200c medications for any signs of adverse reactions and to educate\u2062 them about the possible risks.<\/p>\n<p>Furthermore, it is essential for regulatory agencies like \u200dthe FDA to strengthen their oversight and \u2064ensure that \u2064pharmaceutical\u200d companies thoroughly test their drugs for potential adverse effects before they are approved for use. This\u2062 will help to reduce the occurrence of such adverse reactions\u200c and protect the health and well-being of patients.<\/p>\n<p>In conclusion, the FDA&#8217;s label update for\u2064 Ozempic to include the \u200cacknowledgement of ileus as \u200ban adverse reaction is an important development\u200b in \u200censuring patient safety. However, it also highlights \u200dthe need for better regulation and transparency in the pharmaceutical\u2062 industry.\u2063 Manufacturers must provide accurate and comprehensive information about the potential risks of their medications,\u2064 and regulatory agencies must enforce strict guidelines\u2063 to \u2062protect the health and well-being of patients.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>as Medullary Thyroid Carcinoma (MTC) has been observed in patients taking Ozempic. The FDA advises healthcare professionals to consider MTC in the differential diagnosis of patients experiencing persistent diarrhea or abdominal pain while using the drug. Patients should be informed about the potential risks and symptoms associated with MTC.<\/p>\n","protected":false},"author":69,"featured_media":2048187,"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-2048186","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\/2048186","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\/69"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=2048186"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2048186\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/2048187"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=2048186"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=2048186"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=2048186"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}