SINGAPORE: Two traditional Chinese medicine (TCM) companies are under investigation over a skin cream that has been found to contain potent medicinal ingredients which may lead to adverse effects, the Health Sciences Authority (HSA) said on Wednesday (Jul 23).
Pi De Kang Dermatitis Cream, imported by Da Zhong Tang and supplied by Chinese Medical Centre, was found to contain the steroid clobetasol and an antifungal called miconazole.
HSA has directed the two TCM companies to stop selling the cream and conduct a consumer recall of all product batches that were given to customers.
The authority said it had tested the cream following feedback from a customer, and that both firms are being investigated for the import and supply of the adulterated product. It added that the recall is underway.
Clobetasol propionate is a potent steroid that is usually prescribed for inflammatory skin conditions such as chronic eczema and psoriasis. It should only be used under strict medical supervision, said HSA.
Long-term unsupervised use of steroid-containing creams can cause thinning of the skin, and sudden discontinuation after prolonged use may result in topical steroid withdrawal syndrome, which is characterised by burning, redness, itching, pain or skin peeling.
Topical steroids may also cause adverse effects when applied to large areas of the skin or used over a prolonged period. These include high blood pressure, cataracts, muscular and bone disorders, an increased risk of infections and Cushing’s syndrome, which is characterised by a round or “moon” face appearance, and upper body obesity with thin limbs.
Children and infants are more susceptible to the effects of steroids and as such, may be at higher risk of steroid-associated adverse effects.
Miconazole is used to treat fungal infections, and its inappropriate use could cause skin irritation, itching, skin rash and burning sensation of the skin.
HSA advised consumers of Pi De Kang Dermatitis Cream to consult a doctor as soon as possible if they are using it, as any sudden stoppage of steroid-containing creams without medical supervision may worsen underlying skin conditions or cause topical steroid withdrawal symptoms.
All sellers and suppliers must stop selling the cream immediately, the authority said.
“HSA will not hesitate to take stern enforcement actions against anyone who sells and supplies products found to be adulterated with potent ingredients,” it added.
Sellers and suppliers may be prosecuted and if convicted, face imprisonment for up to two years and/or fined up to S$10,000 (US$7,820).
https://www.channelnewsasia.com/asia/tcm-companies-investigation-pi-de-kang-skin-cream-recall-steroid-antifungal-side-effects-hsa-5253751
