Sylvia Thompson examines the dangers of unlicensed creams available on the open market.
The shocking case last week of a 24-year-old woman who was found to have serious adrenal gland suppression and blood pressure problems following use of a skin-whitening cream which contained a potent steroid has highlighted yet again the dangers associated with unlicensed skin products on sale in the State.
In this case, the cream, which was purchased in an Afro-Caribbean store, was imported from Italy but it did not have a licence for sale in Italy either.
The Nigerian woman who turned up at a dermatology outpatient clinic at Tallaght Hospital with marks on her thighs and inner arms had been using the cream for two years. Tests revealed that the cream contained clobetasol propionate, a potent corticosteroid whose side effects include diabetes and high blood pressure.
"As far as we know this cream, called Movate, is one of the first cases to be highlighted in Ireland. We informed the Irish Medicines Board [IMB] who raided the shop it was purchased in but didn't find anything. The woman herself didn't want to complain to the gardaí so nothing further could be done about it," says Dr Brian Kirby, department of dermatology and endocrinology, Adelaide, Meath and National Children's Hospital, Tallaght.
"These skin-whitening products have been available in other countries for a number of years and their availability here will increasingly become a problem as our population becomes more diverse," says Pamela Logan from the Irish Pharmaceutical Union.
"If a cream says it will lighten the skin, it is most likely to contain a steroid as skin-lightening is a side effect of steroid use. Creams containing steroids can only be used safely on prescription from a GP and dispensed by a pharmacist.
"There are a few steroid creams available over the counter but the steroid in this skin-lightening product, clobetasol propionate, is on prescription only because of its side effects. When it is absorbed into the bloodstream, it causes suppression of the adrenal glands, blood pressure problems and lack of periods in women," says Logan.
"Generally speaking, steroids are for short-term use only on a specific area of the skin. Clobetasol would not be recommended for use on the face so use for skin-whitening would [represent] both inappropriate use and overuse.
"Products such as these are not licensed and come on the market illegally. The key message is that people should not be buying from unauthorised suppliers and there is a huge problem with people purchasing from internet pharmacies," she adds.
The IMB issued a statement last week saying that skin-whitening products were illegal and posed a serious risk to public health. "The IMB would strongly discourage use of these products as they are potentially harmful to the health of users," it said.
As the national licensing authority for medicines in the State, the IMB's role is to guarantee the efficacy, quality and safety of licensed medicines. To this end, it encourages healthcare professionals to report all adverse drug reactions. Its statement on the skin-whitening cream came following the reporting of the case in the Irish Medical Journal by doctors at Tallaght Hospital.
The IMB also carries out surveillance of the market with enforcement officers designated to monitor the sale of illegal products.
In January 2003, the IMB brought a case against Dr Pascal Carmody, a GP from east Clare, relating to the supply and manufacture of unauthorised medicines. Carmody was fined more than €9,000 after pleading guilty. The medicines in question included a steroid-containing cream, peviderm. Carmody was later struck off by the Irish Medical Council for other unorthodox therapies he was using on his patients.
Eighteen months earlier in June 2001, the IMB successfully prosecuted a Limerick-based businessman, Donal Walsh, for illegally selling eczema creams containing steroids.
"Applying a steroidal cream in uncontrolled conditions could have long-term effects. In one instance, it had thinned the skin on an adult's face so the person's veins could be seen," said Hugo Bonar, the IMB's enforcement officer at the time. Walsh had been selling his eczema creams for £30 per tub through 'clinics' in hotels and by mail order with instructions to "apply all over the body six times daily".
At the trial, Bonar produced certificates of analysis, showing the cream contained corticosteroids, prescription-only medicines. People bought the cream - often to treat children - believing it was a herbal remedy.
Dr Gillian Murphy, consultant dermatologist at Beaumont Hospital, says: "The public should be very wary of medical claims without adequate evidence and, in particular, they should avoid products [promoted] by large advertisements in the papers. Your family doctor is there to give you impartial advise... He is not allowed to sell you medicines so he hasn't got a vested interest.
"The problem is that everybody wants a quick fix. Chronic skin conditions such as eczema need proper management. Many people have highly sensitive skin and react very badly to our environment - central heating, air conditioning, soaps, shampoos and conditioners - so a management strategy has to be put in place. Cortisone ointments are only a minor part of the treatment."
Helen McCormack, medical herbalist, raises a further issue in relation to the supply chain of so-called natural products. "It's one thing to knowingly pass something on to patients as natural which has synthetic ingredients added. It's another for practitioners to buy such products from suppliers in good faith.
"As practitioners, it's our responsibility to ensure that the ingredients we use to make up creams for eczema and other conditions come from suppliers who have quality control on ingredients and good manufacturing certificates," she says.
The implementation of the Traditional Herbal Medicines Directive later this year should improve the situation somewhat. Dr Des Corrigan, senior lecturer in the School of Pharmacy, Trinity College Dublin, hopes this directive will give consumers better protection against bogus suppliers of herbal preparations.
"The regulatory system will be put in place to ensure that consumers have access to high quality plant products which have not been damaged either by environmental contaminants or by the deliberate addition of arsenic, mercury, lead or synthetic drugs such as steroids.
"In terms of Chinese herbal medicines for eczema, there is a formulation of 10 Chinese herbs taken as a tea for which there is clinical evidence of its effectiveness in adults and children. However, it's not used as a cream and the problem is that there are some people who are piggybacking on the proven success of the original formulation to sell creams for eczema.
"There will be a requirement that any product licensed under the Traditional Herbal Medicines Directive will have produced evidence of quality control and the most reputable manufacturers of herbal medicines products already meet these criteria," says Corrigan.
Educating members of the public desperately seeking the latest 'miracle cure' for skin conditions to purchase only products which are licensed for sale will, however, continue to be the most difficult task.