Health Canada said some over-the-counter acne products are linked to severe allergies and even life-threatening effects, due to two major components: benzoyl peroxide and salicylic acid.
People with acne commonly use non-prescription products that contain salicylic acid or benzoyl peroxide. In Canada, there are about 400 kinds of such products being sold in the market. Each preparation usually contain 2.5 percent to five percent of benzoyl peroxide or 0.5 percent to two percent of salicylic acid. The products come in various forms such as gels, creams, soaps and lotions.
Some people, however, may develop severe allergic reactions upon applying products containing such agents.
People may develop hypersensitivity or allergic reactions such as skin irritation, itchiness, difficulty of breathing, hoarseness of voice, tight feeling in the throat, fainting and swelling of the face, eyes and lips. In some cases, anaphylaxis may develop, rapidly putting an individual's life at risk.
In June 2014, the US Food and Drug Administration was able to determine 131 reports of allergic reactions after using over-the-counter products containing benzoyl peroxide and salicylic acid. Out of all the cases, 50 were said to have been anaphylactic reactions. The results prompted the agency to warn the public about the potentially severe effects of over-the-counter acne products.
With this, Health Canada conducted a routine health product check, which entailed foreign and Canadian cases of serious allergic reactions linked to benzoyl peroxide or salicylic acid-containing products.
During the safety review, the agency was able to identify 10 Canadian allergic reaction cases linked to the benzoyl peroxide, of which five reached the stage of anaphylaxis.
For salicylic acid, the agency was able to receive a total of 16 Canadian hypersensitivity reaction cases; four of which were anaphylactic cases.
Health Canada also identified two anaphylactic cases wherein benzoyl peroxide and salicylic acid were simultaneously used.
"Health Canada's safety review concluded that there is evidence supporting a link between the use of over-the-counter topical acne products containing either benzoyl peroxide or salicylic acid and serious hypersensitivity reactions," the summary review reads.
With the findings of the safety review, Health Canada has decided to make updates to its Acne Therapy Monograph. Among the additional details that the agency will include are instructions to perform sensitivity testing for first time acne product users, updated warnings about potential side effects and consumer must-do's and lastly, prohibition warnings for those with known allergies to benzoyl peroxide or salicylic acid.
Product makers will be asked to revise labels so these changes will be implemented.
Part of the Canada's effort is to release an information update for medical professionals and consumers, reiterating the risks of the products and informing them of the product information changes.
Meanwhile, Health Canada advised people who encounter signs and symptoms while using over-the-counter acne products to stop and seek medical help.
Photo: Shawn Campbell | Flickr
