In a recent announcement, the FDA warned that many over the counter acne medicines may pose a risk for rare, but severe allergic reactions. The reactions investigated by the FDA include 131 cases from 1969 until January, 2013. The products of concern contained either salicylic acid or benzoyl peroxide, which are found in many over the counter products, including those branded Proactiv, Neutrogena, Clean and Clear, Oxy, and others. The FDA is uncertain whether the problem is due to salicylic acid, benzoyl peroxide, or some other ingredient (such as a color or preservative) in the medications used.
Many people who use over the counter acne products notice mild to moderate skin irritation, dryness, peeling, or redness. However, the reactions included in the warning are much more severe and included severe swelling, difficulty breathing, faintness and throat tighness, usually within minutes to 24 hours of using the medication. 44% of the patients in the series studied by the FDA were hospitalized.
Because of the potential for such severe reactions the FDA is recommending that patients who are using a new over the counter medication for acne use the following procedure to test whether they will have a severe reaction, before they use the acne medication over large areas of skin.
1) For the first 3 days, use the medication only on one or two very small areas of skin.
2) If you notice severe symptoms, such as
- difficulty breathing
- feeling faint or actual fainting or passing out
- swelling of the eyes, lips, tongue, or face
stop using the product and go to the emergency room. Don’t use the product again.
3) If you notice hives or itching over the face or body, also do not use the product again.
4) If you have an allergic reaction to an over the counter medication for acne, report it to the FDA at their Medwatch website. This will help the FDA determine how best to protect future patients from similar reactions.
In general, the products mentioned in the FDA’s safety announcement are very safe. The severe reactions of concern are extremely rare. Benzoyl peroxide continues to keep its place on the FDA’s list of ingredients that are “generally recognized as safe”. Acne sufferers can be confident that the added precautions are a commonsense way of avoiding severe reactions to any medication used on the skin.
Disclaimer: The content offered herein is to educate readers on health care and medical issues that may affect their daily lives. Nothing in the content should be considered, or used as a substitute for, medical advice, diagnosis or treatment. This article does not constitute the practice of any medical advice, diagnosis or treatment. You should always talk to your health care provider for diagnosis and treatment, including your specific medical needs. None of the products or services offered in this article represents or warrants that any particular service or product is safe, appropriate or effective for you. I advise readers to always seek the advice of a qualified health care provider with any questions regarding personal health or medical conditions.