Avoid:
❌ La Roche-Posay Effaclar Duo Dual Action Acne Tx
❌ Walgreens Acne Control Cleanser
❌ Proactiv Emergency Blemish Relief Cream BPO
❌ Proactiv Skin Smoothing Exfoliator
❌ SLMD Benzoyl Peroxide Acne Lotion
❌ Walgreens Tinted Acne Treatment Cream
❌ Zapzyt Acne Tx Gel

4. I'm thankful that we have been having this conversation over the past year to ensure the continued safe use of this foundational acne treatment. I look forward to continuing to work with others on this issue so that we can provide the highest quality care for those with acne.

This aligns with generally reassuring epidemiologic data supporting the safety of benzoyl peroxide containing products (pubmed.ncbi.nlm.nih.gov/39002561/; pubmed.ncbi.nlm.nih.gov/38950699/; pubmed.ncbi.nlm.nih.gov/38909658/;

3. It appears the FDA agrees that the clinical risk is minimal, even for products being recalled (hence why recall is at the retail rather than consumer level). "Even with daily use for decades, the risk of developing cancer because of exposure to benzene found in these products is very low."

2. As we found in our recent @JAMADerm study, there are likely opportunities for manufacturers to re-evaluate their formulation, production, and distribution practices to achieve the goal of minimizing the formation of benzene in benzoyl peroxide products.
jamanetwork.com/journals/jam...

1. The vast majority of products were found to have undetectable or extremely low levels of benzene, which is reassuring. It also highlights that our goal should be insignificant levels of benzene in these products as most manufacturers are able to achieve this goal.

And finally, it is important to consider risks of benzoyl peroxide containing products in the context of other alternative acne treatments that would be required if we avoid these products (and then also topical antibiotics). 8/8
pubmed.ncbi.nlm.nih.gov/38909658/

That being said, I believe we do have opportunities to improve formulation, production, and distribution practices to maximize the safety of benzoyl peroxide products.
pubmed.ncbi.nlm.nih.gov/39937513/
7/8

Finally, there are the general limitations of FAERS and the small sample size. Ultimately, we will need further input from the FDA and prospective studies, but given currently available data, I think the likelihood of clinically meaningful risk is low.
youtu.be/TYcZXjCzt8Q
6/8

There also doesn't appear to be any signal for leukemia/lymphoma, which are the main malignancies one might expect with benzene exposure based on prior studies. 5/8

From a face validity standpoint, it is unlikely that BPO products have a 100x greater risk of lung cancer than smoking. If this were true, we should have easily observed it in our cohort studies. 4/8
pubmed.ncbi.nlm.nih.gov/39002561/

Additionally, 100% of the reports are for Proactiv products, who reportedly are being sued about this issue, which again raises concerns about reporting bias. These lawsuits were likely started prior to March 2024 and could have influenced 2023 data 3/8
www.prnewswire.com/news-release...

Most worrisome, 22/23 of the identified case of malignancy are from 2023-2024, with only 1 reported from 2019-2022 (they don't evaluate earlier years). This is very concerning for reporting bias, potentially influenced by 3rd parties. Notably, you don't see a pattern like this for adapalene. 2/8

I don't even know why we bother writing appeals these days. It seems like the reviewers do not even engage with the content of the letter and just repeat the same rationale as the original denial. I'd like to just skip and go straight to next step to avoid more delays :/

Yes, they likely do work! The effect is relatively mild, but they actually have outperformed even benzoyl peroxide in a couple of head to head trials. It is important to get a model with adequate fluence/irradiance.

jamanetwork.com/journals/jam...