The Food and Drug Administration are warning consumers who use certain over-the-counter skin products for acne to stop using them and seek emergency medical help immediately if they experience extreme allergic reactions such as feeling faint, breathing difficulties, throat tightness or swelling of the eyes, lips, face or tongue.
Consumers should also stop using the products if they develop hives or itching, say the Food and Drug Administration (FDA), who have issued a Drug Safety Announcement and accompanying Consumer Update about topical acne products that contain the active ingredients benzoyl peroxide or salicylic acid.
The over-the-counter (OTC) acne products the FDA is warning about already include a list of reactions in the Drug Facts labels namely: itching, peeling, redness, burning, dryness and slight swelling where the product is applied.
However, the new FDA warning is about rare but serious and potentially life-threatening allergic reactions or severe irritation that are not among the already listed reactions, as Dr. Mona Khurana, a medical officer with the FDA, explains:
“There is currently no mention of the possibility of these very severe allergic reactions on the product labels. It’s important that consumers know about them and that they know what to do if they occur.”
To find out if an OTC acne product contains the active ingredients benzoyl peroxide or salicylic acid consumers should look at the Active Ingredients section of the Drug Facts label on the product package.
Products containing the active ingredients benzoyl peroxide or salicylic acid are available in a number of skin applications, such as face washes, solutions, cleansing pads, gels, lotions, toners, face scrubs and other products.
They are sold under various brand names, including: Ambi, Aveeno, Clean & Clear, MaxClarity, Neutrogena, Oxy and Proactiv.
The FDA say that between 1969 to early 2013, they received 131 reports from consumers and manufacturers about allergic and hypersensitivity-related reactions linked to these products. The people affected were between 11 and 78 years old. The federal agency notes that:
“Based on the information reported to FDA, we cannot determine if the serious hypersensitivity reactions were triggered by the acne products’ active ingredients, benzoyl peroxide or salicylic acid, the inactive ingredients, or by a combination of both.”
The FDA report that 42% of the reactions occurred within minutes to 24 hours of using the product.
No deaths have been reported, but nearly half (44%) of the cases required hospitalization.
Dr. Khuruna says the FDA will continue to monitor and evaluate the safety of the products and is encouraging the companies that make them to use the drug label to inform consumers how to test if the product is safe before they begin to use it.
The FDA advice is to apply a small amount to a small area of affected skin for 3 days – if there is no discomfort or reaction, then it is alright to go ahead and follow the instructions for normal use given on the product label.
The FDA urges consumers who have bad reactions or side effects to report them to MedWatch, the FDA Safety Information and Adverse Event Reporting Program.