FDA gets tough with Allergan over Aczone

Written by on September 1, 2009 in Acne Treatments, Aczone (Dapsone Gel 5%), Allergan with 5 Comments

The FDA has issued a warning letter to Allergan, the makers of Aczone for overstating the efficacy of Aczone and also for understating the possible side effects.

In a sign that the FDA is watching carefully the claims that vendors use when advertising their products, the warning letter calls out a journal advertisement for Aczone as violating the Federal Food, Drug, and Cosmetic Act.

WARNING LETTER

The FDA has reviewed a journal advertisement (APC021052008) for ACZONE® (dapsone) Gel, 5% (ACZONE) (and) this journal advertisement is false or misleading because it grossly overstates the efficacy of ACZONE, and omits material facts and important risk information associated with the use of the product.

I did a bit of digging around and this appears to be the portion of the journal advertisement that attracted the attention of the FDA.

aczone-fda-no-noThe offending advertising claims.

The journal article overstates the effectiveness of Aczone by neglecting to state that at 2 weeks usage, Aczone was only 2% more effective than the placebo vehicle gel. This small difference is not considered statistically significant so it not a true claim of efficacy. The 12 week trial results were also over stated by ignoring the comparative effect of the vehicle gel.

The second part of the warning deals with the omission of important risk information associated with Aczone. Clinical trials found that 7 out of 95 subjects who applied benzoyl peroxide after applying Aczone had yellow or orange discoloration of the skin and facial hair. This discoloration took between 4 and 57 days to resolve.

The FDA attracts a lot of criticism from rosacea sufferers who see the organisation as overly bureaucratic and unnecessarily slowing down new drug applications. We do need a policeman to help protect us from cynical vendors who make claims that are not based on proven facts. Personally I’m glad that the FDA is willing to publicise vendors who try to take advantage of rosacea sufferers.

An important message here is that rosacea sufferers would be wise to be wary of statistical claims in advertising materials. Seek out published proof and clinical trial results before believe what you read.

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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5 Reader Comments

  1. Steve B says:

    Has anyone tried Strata-C cream? They have bold statements about getting rid of the redness from rosacea,and wrinkles too…I’m trying it,and I’ll post results in month or so.

  2. Steve B says:

    PS, how can I find documented proof that Strata-C works?? Has anyone heard of it, or used it??

  3. Dentists Lubbock says:

    I haven’t heard anyone who have tried Strata-C cream, but it would be interesting to know it is really effective.

  4. Pinky says:

    Hi Steve and Dentists,
    Have you tried Aczone/dapsone? I read that the FDA beat up Allergan for overstating the efficacy of Aczone. Don’t let these recent events scare you off the product.
    My skin had become red and inflammed over the lower half of my face, neck and chest. Not only was their redness, inflammation and bumps, but my skin also developed this weird moistness. Eventually my skin macerated in places. I could literally peel off bits of skin using a tweezer. Weepy, red, and peeling skin, however, wasn’t the worst–the pain was severe.
    After a couple of weeks of misery, I found a dermatologist. He diagnosed rosacea and prescribed dapsone. His drug of choice would have been a systemic cycline drug; however, I am allergic to cyclines and sulfonameides. He was left with dapsone as his first choice.
    One application of this med at bedtime resulted in an 80% reduction of pain and redness. I was amazed, comfortable, and happy. My maintenance regimen is dapsone 5% gel topically to affected areas twice daily.
    As to the people whose skin turned yellow when they used benzoyl peroxide concommitantly with dapsone, they should read the directions. The label clearly states not to use benzoyl peroxide while using dapsone because your skin will turn yellow. Duh.
    Try dapsone folks. Who knows? It may work for you too.

  5. impressed says:

    I too am a Rosacea sufferer that has found Aczone to be a miracle drug that has worked wonders for my skin. I have been trying different treatments for over 6 years with absolutely no success. Aczone is the first product that completely clears up the facial redness 100%. After 10 years of suffering, I can’t tell you how happy I am to finally have found a product that works well. It also does not overdry my skin. I have not experienced any redness, itching or dryness since I began using Aczone. I have been able to discontinue the use of moisturizers (which only irritate my skin anyway). Aczone has really worked miracles for me.

    If I understand correctly, Aczone was originally marketed for Acne and was found to be inneffective for acne, but surprisingly effective for Rosacea. The FDA warnings regarding effectiveness are likely a result of the claims regarding effectiveness for Acne.

    I too would encourage Rosaceans to not be so quick to write off Aczone.

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