Proactiv, Neutrogena and other acne products may cause severe allergic reactions, warns FDA
Latest consumer update about over-the-counter acne products warns that some treatments may lead to allergic reactions that can, though rarely, be life threatening. The treatments in question are products that use active benzoyl peroxide or salicylic acid.
These products are topical and can cause a variety of reactions, from minor to serious, including symptoms such as burning, itching, dryness, peeling, redness and swelling.
The U.S. Food and Drug Administration issued the consumer update, reporting that these cases are rare but recommending the use of caution by consumers, product makers and healthcare professionals.
"There is currently no mention of the possibility of these very severe allergic reactions on the product labels," says Mona Khurana of the FDA.
Benzoyl peroxide and salicylic acid are active ingredients often found in topical acne products such as those made by Neutrogena, Aveeno, Proactiv, MaxClarity, Oxy, Clean & Clear and Ambi. The brand name products come in gels, lotions, scrubs and washes, solutions, cleansing pads and toners.
The update is a response to 131 reports of harmful reactions from these products. The FDA received these complaints from consumers and product-makers between 1969 and 2013.
42% of the complaints reported reactions within 24 hours of product use, in people ages 11 to 78. 40% of complaints reported allergy symptoms as severe as low blood pressure, throat tightness and fainting. 44% of symptoms led to hospitalization, but no deaths.
It remains unknown whether these reactions are the result of the active ingredients, which are responsible for the medical properties of the products, or the inactive ingredients or some of the ingredients in combination.
The FDA, in its address of the situation, recommends manufacturers to update drug labels to show users how to test the products before using them fully. Applying small amounts to acne-affected areas before applying the products entirely may catch any reactions before they become full-fledged and serious.
Khurana says in the FDA update to avoid using the product if any reactions occur such as hives, throat tightening, swelling, fainting or wheezing. Reports of adverse reactions can be sent to the FDA's MedWatch program.
The FDA Safety Announcement explains in more detail the kind of hypersensitive reactions that may result from use of these products, what changes manufacturers should consider making on their drug labels, and additional information for healthcare professionals on alerting patients of the possibility of reactions.