{"id":164497,"date":"2025-12-02T17:50:21","date_gmt":"2025-12-02T17:50:21","guid":{"rendered":"https:\/\/www.newsbeep.com\/il\/164497\/"},"modified":"2025-12-02T17:50:21","modified_gmt":"2025-12-02T17:50:21","slug":"tga-issues-weight-loss-drug-safety-alerts","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/il\/164497\/","title":{"rendered":"TGA issues weight-loss drug safety alerts"},"content":{"rendered":"<p>&#13;<br \/>\n    Feature<\/p>\n<p class=\"h6 pt-4 pb-2\">&#13;<br \/>\n            Wegovy and Mounjaro are among the high-profile medicines with new product warnings, with the watchdog linking GLP-1 RAs to new side effects.&#13;\n        <\/p>\n<p>&#13;<br \/>\n    <img decoding=\"async\" alt=\"GP speaking to a patient.\" src=\"https:\/\/www.newsbeep.com\/il\/wp-content\/uploads\/2025\/12\/attachment.aspx.jpeg\" \/>&#13;<br \/>\n    &#13;<br \/>\n        Around half a million GLP-1 RA units were sold each month in Australia in 2024\u201325 \u2013 a 10-fold increase in five years.&#13;<br \/>\n    &#13;<\/p>\n<p>&#13;<br \/>\n    The Therapeutic Goods Administration (TGA) has issued new safety warnings for several high-profile GLP-1 receptor agonists, linking the medications to serious side effects.<br \/>&#13;<br \/>\n\u00a0<br \/>&#13;<br \/>\nOn Monday, <a href=\"https:\/\/www.tga.gov.au\/news\/safety-updates\/updated-contraception-advice-mounjaro-tirzepatide\" rel=\"nofollow noopener\" target=\"_blank\">the TGA updated the product warnings<\/a> for the \u2018relatively new and high-profile\u2019 class of medicines after they were linked to the potential risk of suicidal thoughts, with one also connected to reduced effectiveness of oral contraception.<br \/>&#13;<br \/>\n\u00a0<br \/>&#13;<br \/>\nThe GLP-1 RAs currently marketed in Australia are:&#13;\n<\/p>\n<p>&#13;<br \/>\n\tSemaglutide (sold as Ozempic and Wegovy)&#13;<br \/>\n\tLiraglutide (sold as Saxenda)&#13;<br \/>\n\tDulaglutide (Trulicity)&#13;<br \/>\n\tTirzepatide (sold as Mounjaro)&#13;<\/p>\n<p>As of 23 September, the TGA\u2019s Database of Adverse Event Notifications includes 72 reports for suicidal ideation for the class of medications.<br \/>\n\u00a0<br \/>\nThe medicines watchdog is now advising healthcare professionals to monitor patients for the emergence or worsening of depression, suicidal thoughts or behaviours, or any unusual changes in mood or behaviour.<br \/>\n\u00a0<br \/>\n\u2018Consider the benefits and risks for individual patients before initiating or continuing therapy in patients with suicidal thoughts or behaviours,\u2019 it says.<br \/>\n\u00a0<br \/>\nWhile an investigation found available evidence is not sufficient to support an association between GLP-1 RAs and suicidal or self-harming behaviours, it said product information and consumer medicines information documents across the class were \u2018inconsistent and should be harmonised\u2019.<br \/>\n\u00a0<br \/>\n\u2018Updates should not imply a causal association, but reflect a class level awareness,\u2019 the TGA said.<br \/>\n\u00a0<br \/>\nAn <a href=\"https:\/\/www.tga.gov.au\/news\/safety-updates\/updated-contraception-advice-mounjaro-tirzepatide\" rel=\"nofollow noopener\" target=\"_blank\">additional TGA investigation<\/a> into the potential for reduced effectiveness of oral contraception when first taking or increasing the dose of Mounjaro revealed an association \u2018could not be ruled out\u2019.<br \/>\n\u00a0<br \/>\nIn response, and as a precautionary measure, product warnings for tirzepatide have also been updated to include further advice for patients using oral contraceptives.<br \/>\n\u00a0<br \/>\n\u2018Patients taking tirzepatide are advised to switch to a non-oral contraceptive or add a barrier method of contraception for four weeks after first taking the medicine and for four weeks after each increase in the dose,\u2019 the TGA says.<br \/>\n\u00a0<br \/>\n\u2018None of the GLP-1 RAs should be used during pregnancy\u00a0and individuals of childbearing potential are advised to use effective contraception during treatment with a GLP-1 RA.\u2019<br \/>\n\u00a0<br \/>\n<a href=\"https:\/\/www.medrxiv.org\/content\/10.1101\/2025.10.30.25339120v1\" rel=\"nofollow noopener\" target=\"_blank\">It comes just weeks after a new study<\/a> found around half a million GLP-1 RA units were sold each month in Australia in 2024\u201325 \u2013 a 10-fold increase in five years.<br \/>\n\u00a0<br \/>\n\u2018In the year May 2024\u2013April 2025, over six million units of GLP-1 RA were sold, predominantly semaglutide [63.3%] and tirzepatide [30.7%],\u2019 it found.<br \/>\n\u00a0<br \/>\n\u2018In this period, GLP-1 RA use was estimated to cover 18 out of every 1000 Australians at a standard daily maintenance dose, with six out of every 1000 accessing these medicines privately.\u2019<br \/>\n\u00a0<br \/>\nThe TGA\u2019s latest decision is in response to the United Kingdom\u2019s Medicines and Healthcare products Regulatory Agency publishing <a href=\"https:\/\/www.gov.uk\/government\/publications\/glp-1-medicines-for-weight-loss-and-diabetes-what-you-need-to-know\/glp-1-medicines-for-weight-loss-and-diabetes-what-you-need-to-know\" rel=\"nofollow noopener\" target=\"_blank\">guidance for GLP-1 medicines for weight loss and diabetes<\/a> earlier this year.<br \/>\n\u00a0<br \/>\n\u2018We will continue to monitor the safety of GLP-1 RA medicines and will take appropriate regulatory action to address safety concerns when they are identified,\u2019 the TGA concluded.<br \/>\n\u00a0<br \/>\nLog in below to join the conversation.<\/p>\n<p>&#13;<br \/>\n    <a href=\"https:\/\/www1.racgp.org.au\/newsgp\/allnews?tagname=Mounjaro\" class=\"bdg bdg-pr bdg-lg mb-1 text-white\" rel=\"nofollow noopener\" target=\"_blank\">Mounjaro<\/a> <a href=\"https:\/\/www1.racgp.org.au\/newsgp\/allnews?tagname=Ozempic\" class=\"bdg bdg-pr bdg-lg mb-1 text-white\" rel=\"nofollow noopener\" target=\"_blank\">Ozempic<\/a> <a href=\"https:\/\/www1.racgp.org.au\/newsgp\/allnews?tagname=semaglutide\" class=\"bdg bdg-pr bdg-lg mb-1 text-white\" rel=\"nofollow noopener\" target=\"_blank\">semaglutide<\/a> <a href=\"https:\/\/www1.racgp.org.au\/newsgp\/allnews?tagname=TGA\" class=\"bdg bdg-pr bdg-lg mb-1 text-white\" rel=\"nofollow noopener\" target=\"_blank\">TGA<\/a> <a href=\"https:\/\/www1.racgp.org.au\/newsgp\/allnews?tagname=Therapeutic Goods Administration\" class=\"bdg bdg-pr bdg-lg mb-1 text-white\" rel=\"nofollow noopener\" target=\"_blank\">Therapeutic Goods Administration<\/a> <a href=\"https:\/\/www1.racgp.org.au\/newsgp\/allnews?tagname=tirzepatide\" class=\"bdg bdg-pr bdg-lg mb-1 text-white\" rel=\"nofollow noopener\" target=\"_blank\">tirzepatide<\/a> <a href=\"https:\/\/www1.racgp.org.au\/newsgp\/allnews?tagname=Wegovy\" class=\"bdg bdg-pr bdg-lg mb-1 text-white\" rel=\"nofollow noopener\" target=\"_blank\">Wegovy<\/a> &#13;\n<\/p>\n<p>    newsGP weekly poll<br \/>\n    Have you, or anyone at your practice, been targeted by scammers attempting to access your Provider Digital Access (PRODA) account?<\/p>\n","protected":false},"excerpt":{"rendered":"&#13; Feature &#13; Wegovy and Mounjaro are among the high-profile medicines with new product warnings, with the watchdog&hellip;\n","protected":false},"author":2,"featured_media":164498,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[163,85,46,482],"class_list":["post-164497","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-health","tag-il","tag-israel","tag-medication"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/164497","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/comments?post=164497"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/164497\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media\/164498"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media?parent=164497"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/categories?post=164497"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/tags?post=164497"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}