FDA officials this summer warned about adverse reactions to OTC acne formulations containing benzoyl peroxide or salicylic acid. The agents have been associated with rare, but serious and in some cases lifethreatening allergic reactions or severe irritation, according to the agency. FDA issued a Drug Safety Communication (DSC) to inform both consumers and healthcare professionals of the potential dangers of these products.
Then, just a few weeks ago, FDA reported that a company called Solace International had issued a voluntary recall of its unapproved topical formulation for treatment of moles, warts, and skin tags. Neither the FDA notice of the recall nor the product website provides any information about the ingredients of the formulation or any reported adverse events. The product website does, however, indicate that, “the active ingredients will penetrate to the root and alert your immune system. This immune response will send white blood cells to the blemish and start the removal and healing process.” (The website remained active after the recall, by the way.)
As a dermatologist, I understand that the FDA may have felt a need to warn patients about risks—rare risks—associated with benzoyl peroxide and salicylic acid. These products are popular among both adolescents and adults, and a fair number of our patients use these agents with or without our knowledge and direction.
I am baffled, though, by the lack of action on the mole remover. The recall was described as voluntary and initiated by the product developer. The FDA issued no specific warning and took no action against the manufacturer. Wouldn't it seem that a new product intended to dissolve moles, warts, and skintags warrants more attention than agents that have been safely and effectively used for more than 60 years?
No doubt the men and women who work at FDA are dedicated to advancing public safety. While I may not always agree with the politics that come into play or the business considerations that seem to influence some decisions, the agency has an important role. And the reality is that the agency can't possibly identify or warn on every risk, nor can it assure that every warning is received by the public with the proper perspective.
Against this backdrop, the dermatologist, the expert in the diagnosis and treatment of the skin, hair, nails, and mucous membranes, is an indispensible patient advocate. We can help patients wisely choose and effectively use nonprescription drugs, and we can educate them about the importance of scientifically sound, rational approaches to the management of skin growths and potential malignancies. More than ever, we must continue to assert our role as both experts and educators, empowering patients to seek the best care possible to ensure their long-term health and wellness.
—Joseph Bikowksi, MD, FAAD
Co-Chief Medical Editor