Translation of a-t 2025; 56: 22

Benzene in external acne treatment products containing benzoyl peroxide

In the US, some batches of external acne treatment products containing benzoyl peroxide are being recalled from retailers due to increased benzene contents.¹ The US medicines authority, the FDA, found increased quantities of the carcinogen in 6 out of the 95 products tested (obviously above the limit of 2 ppm^2,3). Some of the preparations affected were approaching their expiration dates. One provider is also recalling its product on the basis of its own tests for increased levels. However, the authority rates the risk of developing cancer (such as leukaemia²) as very low, even if the product is used daily for decades. The FDA recommends that consumers check their medicinal products and dispose products that are beyond their expiration dates.¹ The testing was triggered by analyses performed by an independent laboratory^4-6 in which a significantly higher percentage of the samples tested had increased levels of benzene. However, according to the FDA assessment, these were apparently not measured using a validated procedure.¹ Benzene occurs when benzoyl peroxide degrades.^4-6 Due to the instability of the active substance, most finished medicinal products (e.g. BENZAKNEN) should be stored either in the refrigerator (2-8 °C) or at a temperature of a maximum of 25 °C in Germany. In addition to the shelf life after manufacturing, the shelf life after opening is mostly also limited to 2 to 6 months (e.g. DUAC AKNE 2 months "after handover", AKNEROXID 6 months from opening). According to the Federal Institute for Drugs and Medical Devices (BfArM), no decomposition products that are harmful to health are to be expected if the products are stored correctly.³ Several retrospective observation studies did not identify any link between the use of benzoyl peroxide and cancer or the benzene content in the blood. However, these only appeared as short research letters^7-11 and can therefore only be assessed to a limited extent. We believe that the risk should be further investigated and users informed about the correct storage and limited shelf life, –Ed.

©  arznei-telegramm (Berlin/Germany), March 2025, protected by copyright laws.