FDA Issues Health Warning For Anti-Acne Products

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Admittedly, not a lot alarms us regarding beauty products. We get our hair colored and bleached with reckless abandon, we shrug at the claims of the pounds of chemical-laden lipstick we’ll supposedly consume throughout our lifetime, and the synthetic ingredients in most fragrances barely cause a raised eyebrow. However, a recent announcement from the FDA claiming reports of allergic reactions to two hugely popular and standard acne fighters stopped us dead in our tracks.
The U.S. Food and Drug Administration recently issued a warning that “certain over-the-counter (OTC) topical acne products can cause rare but serious and potentially life-threatening allergic reactions or severe irritation,” which are described as “hypersensitivity reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue” as well as any development of hives and/or itching.
Users of acne products containing the offensive ingredients, benzoyl peroxide and salicylic acid, were instructed to stop using those over-the-counter products immediately if they experienced the aforementioned reactions and to seek emergency medical attention. Yep, you read that right: The agency says you should go to the hospital now if any of those symptoms above apply to you.
Oh, and the FDA named names, too: “The OTC topical acne products of concern are marketed under various brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and as store brands,” said the report. “They are available as gels, lotions, face washes, solutions, cleansing pads, toners, face scrubs, and other products.”
There are, of course, some very important numbers and factors to note here. According to Dr. Doris Day, MD, MA, clinical associate professor of dermatology at New York University Langone Medical Center, "From 1969 through January 28, 2013, the FDA got 131 reports from consumers and manufacturers, which they couldn’t completely or reliably contribute to the usage of the product alone."
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And, since the number of people affected is, well, teeny tiny, your dermatologist probably isn't going to be very happy about this warning. “What’s going to happen now is that people either aren’t going to read the labels, or they’ll read them and panic for no reason,” says Day. “Look at the data they were citing," she says. "How many tens of millions of people were treated with and/or have used benzoyl peroxide and salicylic acid?"
"For 131 reports, you’re now going to scare every single child and adult who has acne, children whose mothers are now going to see these reports and fear using these products because they’re thinking, Ah, this has salicylic acid in it! It could possibly kill my child! He could wind up in the hospital after having a bad reaction to it,” she says. Day is, however, careful to point out that this is not a "nothing" reaction, noting that we must monitor all reactions while also keeping in mind that a person's skin can react to anything, including themselves.
Dr. Jeannette Graf, MD, assistant clinical professor of dermatology at the Mount Sinai Medical Center, also adds that there’s a lot of information missing from the reports. “If you look at the data, the range of ages of those reporting reactions was 11 to 78, which is a big range of patients. You have to think about how you use the products at different ages; you use acne products differently as a teenager (11 to 15) than you do at 78. So, if you’re speaking about someone who is older with no moisture barrier, no buffering capacity, and a pH that’s off balance and may be misusing the products, that could be cause for some serious issues.”
So, let’s just say that you’re not taking any chances. The good news is you have plenty of options. “You don’t have to panic. That’s the best part,” advises Dr. Day. “The good thing is that most of the products we use [as doctors] don’t contain salicylic acid. That’s an over-the-counter product. I have so many options that don’t contain those ingredients. I have patients who have issues with benzoyl peroxide, and even if the reaction isn’t of an allergic variety, if they have sensitivity to it, they’ll know and just stop using it. There doesn’t need to be a warning. People are smart; they’ll stop using something if it causes problems.”
Dr. Day suggests retinoids, like Tazorac and Retin-A, as well as Aczone — a twice-a-day product that’s well tolerated by many people. "I use it for adult acne as well, because lots of women suffering from that condition can be sensitive to benzoyl peroxide anyway, so it’s nice to have other ingredients,” she says.
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So, how do you find out if you’re allergic to a product without, you know, the whole throat-closing, fear-of-dying reaction? “Your dermatologist or doctor can do a patch test on you so we can see the rate of the response and determine allergic reaction,” advises Dr. Day. No time for a derm appointment or currently singing the health-care blues? Both pros advise a spot test on the inside of your forearm. “It’s an area where you can tell if you’re having a reaction because it’s not very sensitive, so if there’s a problem reaction there, it’s usually more of the allergic variety than a product sensitivity."
Just be warned that it might take a couple of tries to determine if you’re particularly sensitive or allergic. “Usually, you won’t have a reaction to something the first time you use it,” says Dr. Day. “It’s usually the second or third time, but it will happen quickly if it’s going to happen.”
Dr. Day maintains that your dermatologist is the best source of information on this matter. “The good news is we have so many medicines that can help acne, and if it drives patients into the dermatology office where we can help our patients and have a conversation about how to use prescription and OTC ingredients together properly for great results, then we’re in really good shape. The patients for whom I fear are the ones who won’t come to the doctor, who think they just have to live with acne and scarring and end up suffering for no reason.”
Bottom line: Keep an eye out for any adverse reactions, but carry on banishing blemishes. As you were, everybody.

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