Expert Reactions: FDA's New Warning on Benzoyl Peroxide & Salicylic Acid

Expert Reactions:  FDA's New Warning on Benzoyl Peroxide & Salicylic Acid

The FDA recently issued a warning regarding topical acne products that may have dangerous side effects (copy and paste this URL into your browser to see the announcement: 
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm402441.htm).
We wanted to provide you with a place where you could get the facts in an easy to understand way. 

When it comes to our health, wellness or beauty, we deal with a significant number of choices regarding products that claim to be able to help us, or perhaps help us meet our personal goals. Considering how complex these decisions can be and how laborious the potential research may be, we often make our decisions based on assumptions instead of on thoroughly collected and analyzed information. 

One often held assumption for many consumers is the belief that products available without prescription that can be bought over the counter (also known as OTC products) are inherently safe - like most acne products - we'll get back to that in a moment. 

What most people don't know is that products such as Advil (ibuprofen) and Tylenol (acetaminophen) were originally available only as prescriptions before being approved as OTC products. Today,  certainly consumers understand some of the cardiovascular safety and stomach concerns associated with Advil  (NSAIDS/non-steroidal anti-inflammatory drugs) as well as the precautions of consuming alcohol with Tylenol. These particular issues had been rather thoroughly discussed in the media. Unfortunately, this is rather an exception not a norm as understanding over the counter products limitations that would allow consumers the ability to use these products safely does not apply to all products. 

Topical products are especially too often treated with a certain dose of carelessness. After all - they don't go inside of our bodies, right? Wrong! Topical products have the potential do us serious harm. For people with acne or acne prone skin, making assumptions about topical, over the counter products is a common occurrence and it may be unfortunately associated with certain unrecognized side effect risks. This is particularly true with respect to acne and oily skin products containing two ingredients: benzoyl peroxide and salicylic acid. 

Many consumers assume that topical acne products that contain benzoyl peroxide and salicylic acid are also inherently safe. After all, these are two of the most common ingredients present in topical acne products. Once again assuming these products used alone or in combination are perfectly safe would be erroneous. 

In short, the new FDA warning alerts consumers that benzoyl peroxide and salicylic acid have been reported to be associated with not so frequent but severe allergic reactions. The FDA warning was meant to alert consumers that the combination of benzoyl peroxide plus salicylic acid may be responsible for these severe side effects, that are mostly allergic reactions. Caution should be used when using either product alone or in combination to make certain an individual does not have such a  serious allergic reaction or skin irritation. The key point the FDA is making to consumers is to be cautious and mindful when selecting and starting  to use acne medications at large and topical acne products in particular.

It is also important for consumers to understand that benzoyl peroxide alone or in combination with  salicylic acid does not address the cause (etiologic factor) of acne but only the symptoms (pimples and comedones). The cause of acne is over active sebaceous glands which release too much sebum (skin oil) into the pores of the skin causing them to clog. Clogged pores can manifest themselves as white heads and black heads (comedones). If the clogged pores attract bacterial growth, the pores can become  inflamed and the "symptom" is now acne pimples and pustules. 

The only FDA approved drug that addresses the cause of acne is Isotretinoin, but due to the multitude of side effects (some very serious) this drug is reserved for adults only and only for the most serious forms of acne. It is also accompanied by several warnings and the patient must sign a release form before actually receiving a prescription. Its branded form Accutane, which is actually off the market and a subject of Class Action Suite for the heath damages it has caused. 

We have that safe alternative; AcnEase® is  an all-natural (all botanical) herbal medicine that works to reduce sebaceous gland secretions from the inside out. AcnEase® is distinct from topical products such as those containing benzoyl peroxide and salicylic acid since the ingredients present in AcnEase prevent pimples from forming rather than simply addressing the symptoms. An added benefit of AcnEase is that it can be used by women and men of different ages (teens and adults), skin types and tones. AcnEase can also be combined with an existing well-tolerated acne improvement skincare and dietary regimen since it prevents new pimples and comedones from forming without interfering with hormones levels and other products.  

With a promise of clear skin,
Dr. A & Dr. G 



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