{"id":9406,"date":"2025-05-06T18:57:52","date_gmt":"2025-05-06T16:57:52","guid":{"rendered":"https:\/\/regulatory.cosmeticsinmind.com\/blog\/aemps-issues-warning-on-the-misuse-of-hyaluronidase\/"},"modified":"2026-02-10T12:45:01","modified_gmt":"2026-02-10T11:45:01","slug":"aemps-issues-warning-on-the-misuse-of-hyaluronidase","status":"publish","type":"blog","link":"https:\/\/regulatory.cosmeticsinmind.com\/en\/blog\/aemps-issues-warning-on-the-misuse-of-hyaluronidase\/","title":{"rendered":"AEMPS Issues Warning on the Misuse of Hyaluronidase"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; admin_label=&#8221;section&#8221; _builder_version=&#8221;4.16&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_row admin_label=&#8221;row&#8221; _builder_version=&#8221;4.16&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text admin_label=&#8221;Texto&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h4 data-start=\"130\" data-end=\"404\"><strong data-start=\"130\" data-end=\"148\">On May 6, 2025<\/strong>, the Spanish Agency for Medicines and Medical Devices (AEMPS) issued a new warning regarding the use of hyaluronidase in aesthetic settings, highlighting the risks associated with its inappropriate use as an injectable when marketed as a cosmetic product.<\/h4>\n<p data-start=\"406\" data-end=\"671\">Hyaluronidase is available both as a topical cosmetic and as an injectable medicinal product. In both cases, it often comes in similar formats\u2014such as vials or ampoules\u2014leading to confusion and documented cases of misuse, with serious consequences for human health.<\/p>\n<h5 data-start=\"673\" data-end=\"693\">Identified risks<\/h5>\n<p data-start=\"695\" data-end=\"1061\">The AEMPS has detected cases in which aesthetic clinics have injected cosmetic-grade hyaluronidase\u2014an illegal practice under current legislation that poses a public health risk. Despite labels clearly stating \u201ctopical use only \u2013 do not inject,\u201d misleading advertising, informal training, or verbal recommendations have promoted inappropriate and dangerous practices.<\/p>\n<h5 data-start=\"1063\" data-end=\"1089\">Key legal distinctions<\/h5>\n<ul data-start=\"1091\" data-end=\"1188\">\n<li data-start=\"1091\" data-end=\"1188\">\n<p data-start=\"1093\" data-end=\"1188\"><strong data-start=\"1093\" data-end=\"1119\">Cosmetic hyaluronidase<\/strong>: Must only be used topically. Injectable use is strictly prohibited.<\/p>\n<\/li>\n<\/ul>\n<h5 data-start=\"1190\" data-end=\"1215\">AEMPS recommendations<\/h5>\n<ul data-start=\"1217\" data-end=\"1484\">\n<li data-start=\"1217\" data-end=\"1305\">\n<p data-start=\"1219\" data-end=\"1305\"><strong data-start=\"1219\" data-end=\"1229\">Verify<\/strong> whether the product is classified as a cosmetic or a medicine before use.<\/p>\n<\/li>\n<li data-start=\"1306\" data-end=\"1362\">\n<p data-start=\"1308\" data-end=\"1362\"><strong data-start=\"1308\" data-end=\"1324\">Never inject<\/strong> any product labelled as a cosmetic.<\/p>\n<\/li>\n<li data-start=\"1363\" data-end=\"1484\">\n<p data-start=\"1365\" data-end=\"1484\"><strong data-start=\"1365\" data-end=\"1427\">Keep authorised injectable hyaluronidase medicines on hand<\/strong> to address complications from hyaluronic acid fillers.<\/p>\n<\/li>\n<\/ul>\n<p data-start=\"1486\" data-end=\"1774\">The AEMPS stresses the importance of properly distinguishing between product categories and complying with existing regulations to avoid health risks. It also reminds professionals of the need to report adverse incidents to support improved surveillance of cosmetics and medical products.<\/p>\n<p data-start=\"1776\" data-end=\"1833\">You can read the full announcement at the following <a href=\"https:\/\/www.aemps.gob.es\/informa\/la-aemps-informa-sobre-el-uso-correcto-de-la-hialuronidasa\/\" target=\"_blank\" rel=\"noopener\">link<\/a>.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On May 6, 2025, the Spanish Agency for Medicines and Medical Devices (AEMPS) issued a new warning regarding the use of hyaluronidase in aesthetic settings, highlighting the risks associated with its inappropriate use as an injectable when marketed as a cosmetic product.<\/p>\n","protected":false},"author":29,"featured_media":10393,"comment_status":"closed","ping_status":"open","template":"","categories":[399],"class_list":["post-9406","blog","type-blog","status-publish","has-post-thumbnail","hentry","category-blog-en"],"_links":{"self":[{"href":"https:\/\/regulatory.cosmeticsinmind.com\/en\/wp-json\/wp\/v2\/blog\/9406","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regulatory.cosmeticsinmind.com\/en\/wp-json\/wp\/v2\/blog"}],"about":[{"href":"https:\/\/regulatory.cosmeticsinmind.com\/en\/wp-json\/wp\/v2\/types\/blog"}],"author":[{"embeddable":true,"href":"https:\/\/regulatory.cosmeticsinmind.com\/en\/wp-json\/wp\/v2\/users\/29"}],"replies":[{"embeddable":true,"href":"https:\/\/regulatory.cosmeticsinmind.com\/en\/wp-json\/wp\/v2\/comments?post=9406"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regulatory.cosmeticsinmind.com\/en\/wp-json\/wp\/v2\/media\/10393"}],"wp:attachment":[{"href":"https:\/\/regulatory.cosmeticsinmind.com\/en\/wp-json\/wp\/v2\/media?parent=9406"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regulatory.cosmeticsinmind.com\/en\/wp-json\/wp\/v2\/categories?post=9406"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}