Subject: Vs: Press Question from Euractiv Journalist Re: Benzene in Acne Products
From: "Carmen Katariina Sikk" <[email-masked]>
To: <[email-masked]>
Date: Wed, 17 Apr 2024 14:12:43 +0300

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-masked]

From: Olivia Gyapong <[email-masked] 
<mailto:[email-masked]> >
Sent: esmaspäev, 15. aprill 2024 14:57
To: Olivia Gyapong <[email-masked] 
<mailto:[email-masked]> >
Subject: Press Question from Euractiv Journalist Re: Benzene in Acne 
Products

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu 
saatja korral palume linke ja faile mitte avada.

Hello,

My name is Olivia Gyapong, and I am a reporter with Euractiv. The FDA in the 
USA is being asked to recall several acne products because they were found 
to have elevated levels of the carcinogen benzene. I was wondering if your 
national regulatory body has been alerted to similar issues with acne 
medications/products sold in the EU, and whether it is planning on 
announcing a recall of products containing benzoyl peroxide and/or dangerous 
concentrations of benzene.

Would someone from your agency be willing to speak with me about this issue 
today or later this week? Thank you! You can reach me at +1 240 483 1932, or 
I am happy to set up a video call.

Best,

Olivia Gyapong

-- 

Olivia GYAPONG

Reporter

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