Health Canada is advising Canadians that it seized two unauthorized ZO Medical skin-whitening creams from Toronto Dermatology Centre (4256 Bathurst St. Suite 400) in North York, Ontario, because they may pose serious health risks, such as blisters, scarring, skin discolouration and possibly cancer.
The products are labelled to contain a 4% hydroquinone concentration. As of June 30, 2019, products for topical use exceeding a 2% hydroquinone concentration require a prescription from a healthcare practitioner in order to be sold in Canada.
Prescription drugs should be used only under the advice and supervision of a healthcare professional because they are used to treat specific conditions and may cause serious side effects.
Health Canada withdrew its authorisation for all topical products exceeding a 2% hydroquinone concentration that were previously available for sale without a prescription, and companies voluntarily recalled these products from the Canadian market.
The Toronto Dermatology Centre was found to be selling the two products that were subsequently seized by Health Canada, despite the fact that it is illegal to sell unauthorised health products and that the products had been recalled.
Hydroquinone for topical use at concentrations above 2% is a prescription drug used to lighten areas of darkened skin caused by different conditions (e.g., sun exposure, skin damage, pregnancy, medications or age). It should not be used by people who are allergic to hydroquinone or who are taking medicines that make their skin more sensitive to light.
Hydroquinone is not recommended for pregnant or breastfeeding women, or children. It should be used with caution in those who have previously had cancer. Side effects include skin reactions such as redness, dryness, cracked skin, burning, stinging, peeling, itching, increased sensitivity to sunlight, sunburn, blisters and scarring.
It may cause skin discolouration (i.e., blue or black discolouration or white patches or spots) that, in some cases, can be disfiguring. In laboratory animals, it has been associated with cancer after long-term exposure.