HEALTHNET

Knowing more about Drug: new topical preparations in eczema

Steroid-containing preparations are the mainstay of treatment for alleviation of inflammation and itchiness...

(Posted on 26 October 2006)

What is "Atopic dermatitis"?

"Atopic dermatitis" is a common inflammatory skin condition, manifested by usual early onset in childhood thus so called "infantile eczema". As far as treatment is concerned, steroid-containing preparations are the mainstay of treatment prescribed by the doctor for alleviation of inflammation and itchiness. But common side effects from steroid preparations such as skin atrophy, stretch marks on skin, inflammation of small blood vessels and skin pigmentation often restrict their usefulness in the treatment of chronic dermatitis.

Treatment of "Atopic dermatitis" by external preparation

Recently, new steroid-free external preparation had been manufactured and registered for sale in Hong Kong. At present, there are two types of such preparation available on prescription on the market, namely ELIDEL® and PROTOPIC®. Unlike the traditional use of steroid preparations, this new generation of topical anti-inflammatory preparations is not associated with common side effects of steroid preparations. The new treatment acts by suppressing and interfering with the over-activity of immune reaction which is known to be responsible for the inflammation and itchiness in eczema.

These new topical ointments have been widely used in many countries worldwide for almost 3 years. However, in February 2005, the FDA has issued a public health advisory to inform healthcare professionals and patients about a potential cancer risk from use of ELIDEL® and PROTOPIC®. As of December 2004, the FDA had received at least 29 case reports suggesting the development of cancer-related symptoms in patients treated with either product.

The potential risks of applying steroid-free external preparation

Besides of case reports in a small number of patients, FDA emphasizes that a causal relationship has not been established and no increase in incidence of cancer risk had been revealed from the 3-year post-marketing clinical trial of these products. The FDA, however, still recommended the manufacturers to add a "Boxed Warning" about the potential cancer risk on the label of these two products in February 2005. Meanwhile, the FDA recommends both health care professionals and patients to use ELIDEL® and PROTOPIC® only as second-line agent and should be avoided in children less than 2 years of age. In addition, the use of these preparations should be restricted to short-term and intermittent treatment of moderate to severe atopic dermatitis as advised by dermatologists. Under any circumstances one should always consult a doctor for professional advices before consider using any of these preparations as a treatment option.

Source: Source: Hong Kong and Drug Education Resources Centre, The Society of Hospital Pharmacists of Hong Kong