Health Canada issues warning about potent steroid in PureCare skin product
Sheryl Ubelacker, The Canadian Press
Published Tuesday, March 28, 2017 1:48AM EDT
Last Updated Wednesday, March 29, 2017 9:06AM EDT
TORONTO -- Parents should think twice before treating their babies and young children with so-called "natural products" for skin conditions like eczema and psoriasis because such creams may be unregulated or contain potentially hazardous ingredients, a pediatric dermatologist says.
"Sometimes patients hear about a natural product and they are falsely reassured that 'natural' means safe," Dr. Irene Lara-Corrales of the Hospital for Sick Children in Toronto said Tuesday.
"And those two are not synonyms. Natural does not mean safe."
The physician's advice follows a warning issued Monday by Health Canada about undeclared ingredients in PureCare Herbal Cream, a skin product promoted as a natural treatment for eczema and psoriasis.
The federal department said the herbal cream, which contains a prescription steroid called clobetasol propionate and the compound phenoxyethanol, could pose "serious health risks" to young children.
Health Canada advised consumers to stop using the product -- sold online at www.purecareskin.com and through an in-person distribution network -- and to check with a medical practitioner if they have health concerns.
The cream has been sold with two different labels. The current label states the product is "for extremely dry skin," while the previous label described it as an "herbal cream for eczema, psoriasis and dry skin."
PureCare Herbal Cream Ltd. said in a statement posted on its Facebook page, where it goes by the name PureCare Skin, that Health Canada informed it last Thursday that some clobetasol propionate was present in its product.
The company is offering customers refunds and said it is following up with the manufacturer, which it said had "expressly informed" PureCare Skin that "the product was all natural and free from any drugs or parabens."
"PCS does not believe that past use of this product would have caused any damage or injury to any of its users," the company said in its Facebook posting. "However, out of an abundance of caution and as mandated by Health Canada, we have ceased all sales and have instituted a recall action plan."
Lara-Corrales said dermatologists do use steroids to treat youngsters with psoriasis or eczema -- common conditions caused by inflammation of the skin -- "but we would never use anything as strong as clobetasol."
Calling the compound an ultra-potent steroid, she said the drug can be absorbed into the bloodstream and affect young children systemically, potentially causing such adverse effects as high blood pressure, stomach irritation and the puffy cheeks known as a "moon face."
Absorbing the agent could also suppress the body's natural production of steroids, including the stress hormone cortisol, which could take time to resume once the skin product is stopped, she said. Prolonged treatment with steroids could also affect a child's growth.
Phenoxyethanol, the other undeclared ingredient in PureCare Herbal Cream identified by Health Canada, is an alcohol-based compound used as a preservative in many creams and cosmetics.
"I think the concern with that one is more if it is ingested. So, for example, if the mom puts the cream on the hands and then (the baby) licks their hands, there might be some exposure to this compound," said Lara-Corrales, explaining that phenoxyethanol is associated with vomiting, diarrhea and difficulty breathing.
She said topical steroids are the first line of treatment for all kinds of skin problems, including both psoriasis and eczema, and are extremely safe if used properly and at the correct dose.
"What we don't do as physicians is prescribe the strongest topical steroid out there to treat something that we know is going to respond to something much, much milder.
"So we never go past a certain potency."
Health Canada has asked PureCare Skin to stop selling the product and to recall it from the market. The Mississauga, Ont.-based company said in its statement that customers who return the product will receive a refund within four to six weeks. Information about a refund can be obtained by emailing email@example.com.