FDA Cautions Against Using OTC Products to Remove Skin Spots, Moles

Maiya Focht

Disclosures

June 10, 2022

Dr Adam Friedman

Those moles, skin tags, and liver spots should stay on your skin until you see a doctor, according to a new alert from the US Food and Drug Administration (FDA). The alert warns against the use of over-the-counter products for removing moles, seborrheic keratoses (wart-like growths that are often brown), or skin tags, emphasizing that none are approved by the FDA for at-home use.

Dermatologists and the FDA say these products may lead to scarring and disfigurement.

Risks include "skin injuries, infection requiring antibiotics, scarring, and delayed skin cancer diagnosis and treatment," according to the alert, which adds that the agency has received reports of people "who developed permanent skin injuries and infections after using products marketed as mole or skin tag removers. "

These products come in the form of gels, liquids, sticks, or ointments and commonly contain ingredients like salicylic acid, which are cytotoxic, or cell-killing. These chemicals are what make the products potentially dangerous, as each contains unregulated, and likely very high, amounts of these corrosive agents. Even products marketed as natural or organic have these same issues, said Adam Friedman, MD, professor and chief of dermatology at George Washington University, Washington, DC, who notes that bloodroot is another ingredient found in these products.

Friedman explained that using these products without the supervision of a healthcare provider can create a chemical burn in the skin, leading to scarring. He's treated patients for open wounds and infected ulcers caused by these products. "Over my career, I've seen many cases of patients coming in with self-inflicted harm due to using these quote, unquote, safe and natural products to remove benign, or even worse, potentially malignant neoplasms," he told Medscape Medical News.

Another concern is that these spots on the skin are often the only sign of a serious issue — cancer. Early signs of melanoma, a type of skin cancer, include large, misshapen, or rapidly changing moles. Friedman said that if a patient uses one of these products on what is actually a cancerous mole, they will likely only remove the surface, and in turn, destroy the only sign of cancer — effectively killing the canary in the coal mine.

There's a good chance that the root of the mole has been left intact under the skin surface, and as a result, the cancer has the potential to spread unnoticed. "If people aren't going to a dermatologist to be properly diagnosed and properly managed, they're going to cause more harm by thinking that they've taken care of a problem," he said.

If you are concerned about any type of spot on your skin, a visit to the dermatologist will prove much simpler and safer for treating it than doing so at home. In the office, Friedman said, providers can use a range of highly studied techniques to remove skin lesions with minimal pain and scarring. From freezing, burning, snipping, or a quick moment under a scalpel, you'll be healed in no time.

Anyone who has experienced an adverse event with one of these products, and healthcare professionals, should report cases to the FDA's MedWatch Adverse Event Reporting Program.

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