Aemps orders three creams marketed as cosmetics be withdrawn from market in Spain due to possible health risks
The products contain active ingredients with a local anaesthetic effect which may cause a variety of problems, including serious adverse reactions
The Spanish agency for medicines and health products (Aemps) has withdrawn from the market three creams, which are sold in the cosmetics category although they contain active ingredients with local anaesthetic effects that give them the status of medicines. In addition, their content indicates that they may also cause damage to people's health.
The creams in question are Lemon, Proaegis and Dermasa. Aemps has ordered their ban and withdrawal from the market. The analysis carried out by the Aemps laboratory confirmed the presence of lidocaine, prilocaine and tetracaine - active ingredients with a local anaesthetic effect - as well as salicylic acid, which is a keratolytic agent, in concentrations sufficient to restore, correct, or modify a physiological function by exerting a pharmacological action. However, these substances have not been indicated on the label, which conceals their true composition and puts the consumer at serious risk.
The administration of local anaesthetics may cause reactions such as erythema, oedema or pruritus. When they reach high concentrations in the systemic circulation, there is even a risk of methaemoglobinaemia.
Some ingredients do not appear on the labels of Lemon, Proaegis and Dermasa
What amount of the drug reaches the systemic circulations depends on the amount applied, the exposure time and the condition of the skin. Absorption can be significant when the medicine is used on mucous membranes or damaged skin, as occurs during tattooing or permanent make-up procedures (lip micropigmentation, hair-on eyebrow design or microblading, among others), where the skin's physical and immunological barrier is altered. Salicylic acid is a keratolytic active ingredient that may cause irritation or stinging in the area of application.
Fraudulent distribution rise
Aemps has detected an increase in the distribution of illegal anaesthetic creams intended for use in aesthetic procedures, such as microblading or photoepilation, as well as in the preparation of the skin prior to tattooing. These products are also sold on fraudulent websites and through social media.
In view of this situation, the agency recommends not to use these creams due to the possibility of serious adverse effects. It also states that all the information on authorised medicines is available at the Centro de Información online de Medicamentos Autorizados de la Aemps (Cima).
