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.
Hyaluronidase is available both as a topical cosmetic and as an injectable medicinal product. In both cases, it often comes in similar formats—such as vials or ampoules—leading to confusion and documented cases of misuse, with serious consequences for human health.
Identified risks
The AEMPS has detected cases in which aesthetic clinics have injected cosmetic-grade hyaluronidase—an illegal practice under current legislation that poses a public health risk. Despite labels clearly stating “topical use only – do not inject,” misleading advertising, informal training, or verbal recommendations have promoted inappropriate and dangerous practices.
Key legal distinctions
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Cosmetic hyaluronidase: Must only be used topically. Injectable use is strictly prohibited.
AEMPS recommendations
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Verify whether the product is classified as a cosmetic or a medicine before use.
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Never inject any product labelled as a cosmetic.
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Keep authorised injectable hyaluronidase medicines on hand to address complications from hyaluronic acid fillers.
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.
You can read the full announcement at the following link.