Answers to Questions

Hello Olivia

Unfortunately we cannot arrange a (video) call for you with our specialist for this week, but I will forward you a written answer from our specialist Laivi Saaremäel (Head of Bureau of Quality Assessment):

Thank you for contacting us and bringing up an important topic with respect to safety of patients.

Hereby we can inform you that currently we do not see urgent need to start immediate action with respect to medicinal products containing benzoyl peroxide as in case of authorised products restrictions in storage conditions are applied. For OTC product AKNEFUG-OXID MILD 50 MG/G, gel as well as prescription only Duac Gel and Irexime gels the product must be stored at refrigerator (2 °C…8 °C) and in case of Epiduo gel the restriction below +25 °C is obligatory. As potential formation of benzene is usually observed at elevated temperatures such risks in authorised medicines is mitigated with restrictions in storage conditions. It can also be highlighted that during the marketing authorisation procedure the ICH Q3C requirements are strictly followed and any use of benzene in production of medicines is not accepted. Even in synthesis of the drug substance any introduction of benzene has to be avoided, hence we can be assured that presence of benzene in authorised medicinal products is already minimal and announcements to recall of products containing benzoyl peroxide is not foreseen at the moment.

Still we would like to remind that several sanitizers or cosmetic products that are not considered medicines may contain significant amount of benzoyl peroxide, but which are not under the responsibility of the State Agency of Medicines, hence we suggest to contact Health Board.

Carmen Katariina Sikk

Agency of Medicines
Head of Communications

Tel 737 4140

[email protected]