Posted in Drug & Medical Devices on June 26, 2014

The U.S. Food and Drug Administration (FDA) issued a warning that some products used to treat acne may cause potentially life-threatening side effects. According to an agency press release, over-the-counter acne products containing the active ingredients benzoyl peroxide or salicylic acid can cause severe irritation or even fatal allergic reactions.

The FDA warning names popular topical acne medications such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, and Clean & Clear. Available without a prescription, these treatments are available as gels, lotions, facial washes, solutions, cleansing pads, toners and face scrubs.

Serious allergic reactions differ from the less harmful irritations included in acne treatment warnings, which include burning, dryness, itching, peeling, redness, and slight swelling where the product is applied.

“There is currently no mention of the possibility of these very severe allergic reactions on the product labels,” says FDA medical officer Dr. Mona Khurana. “It’s important that consumers know about them, and that they know what to do if they occur.”

Use Acne Products Safely

While severe reactions are rare, there are important steps you can take to protect yourself. For example, if you have never used a topical acne treatment before, the FDA recommends applying a small amount of the product to a small affected area for three days. If no discomfort occurs, then follow label directions for normal use. Other safety measures include the following:

• Avoid using the product if you’ve had previous allergic or hypersensitivity reactions
• Stop using the product if you develop hives or itching of the face or body
• Discontinue use and seek immediate medical attention if you develop throat tightness or swelling of the eyes, face, lips or tongue; feel faint; or have difficulty breathing

Although no deaths have been reported, nearly half of the 131 known cases of allergic and hypersensitivity required hospitalization, with the majority since 2012. Approximately 86 percent of the patients were female, and the average patient age was 32 years. Based on the information reported, the FDA cannot determine if these reactions were triggered by the products’ active ingredients, the inactive ingredients, or a combination of both.

“FDA will continue to monitor closely and evaluate this safety issue,” Khurana says. The FDA encourages consumers to report any negative reactions or side effects from use of these products to the FDA’s MedWatch program.

Source: “FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne products.” U.S. Food and Drug Administration, Safety Announcement, June 25, 2014.