The FDA has issued a warning that some popular acne treatments can cause swelling of the face and difficulty in breathing in a rare but potentially deadly allergic reaction. Two active ingredients common in acne treatments, benzoyl peroxide or salicylic acid are believed to be the causes.
Although, it is still unclear whether it is one of these components or some sort of combination that triggers a response.
The over-the-counter treatments are sold as Proactiv, Neutrogena, MaxClarity, Oxy, Aveeno and other brands. For now the agency wants consumers to stop using the products immediately if they experience tightness of the throat, breathing problems, lightheadedness or swelling of the eyes, face or lips. Regulators say the problems are much more serious than rashes often seen with skin products.
“There is currently no mention of the possibility of these very severe allergic reactions on the product labels,” says Mona Khurana, M.D., a medical officer at FDA. “It’s important that consumers know about them and that they know what to do if they occur.”
From 1969 to January 28, 2013, FDA received 131 reports from both consumers and manufacturers of allergic and hypersensitivity related adverse reactions associated with these products. About 42% of these reactions occurred within minutes to 24 hours of use. The affected persons ranged in age from 11 to 78 years.
Forty percent of these reports described severe allergy symptoms such as throat tightness, shortness of breath, wheezing, low blood pressure, fainting or collapse. Isolated instances of hives, itching of face or body (even of parts of the body where the person did not apply the medication) and swelling of eyes, face and lips were also reported.
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.
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.
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.
It is important to be informed, but it is also important to be reasonable.
No one should be afraid of these acne treatments. With proper monitoring and understanding the problem, these treatments will be safe most of the time.