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IMEDEEN WITHDRAWL

The withdrawal of Imedeen Prime Renewal, one of the Imedeen range of food supplements by Ferrosan Ltd from the market during 2006 refocused the importance of food supplement quality assurance, regulation and control ( Food [ Control of Irradiation] Regulations 1990), to protect the public and users, regards safety. An initial communication was posted on the web 04/2006
(ww.food.gov.uk/enforcements/elerts/2006/jan/ferrosanimedeen ), and followed up by warning in 04/2006 ( Foods Standards Agency). Legislation required that the food supplement should be withdrawn because of the undeclared presence of irradiated white tea extract . The import and sale of the Imedeen product did not meet the requirement of Food Labelling Regulations 1990.For further details the reader can review the Food alert and Agency advice. For the public, a drug recall is important, although Ferrosan Ltd stated that there were no immediate food safety implications. To protect the product, a disclaimer statement was made on the advertising brochure that statements have not been evaluated by the FDA. In addition," These products are not intended to diagnose, cure or prevent diseases". More details on the range of Imedeen products can be seen by reviewing www.Imedeen.US/CLDR .

BOLANDCELL provide a brief and balanced review of the potential side effects of Imedeen. The sudden withdrawal of the Imedeen product in 2006, followed on a scientific publication by Skovgaard from the University of Copenhagen , regarding the application of Imedeen Prime Renewal ( Eur J Clin Nutr 60:1201-6, 2006). One drawback of the use of Imedeen in that publication was the very long lead time before improvement of facial wrinkles could be detected (6 months). This may be due to slow GIT absorption of the active ingredients.

INGREDIENTS OF IMEDEEN

According to the publication in Eur J Clin Nutr 2006, Imedeen contains: soy extract, fish protein polysaccharides, extracts from white tea, grape seed and tomato, vitamins C and E as zinc and chamomile extract. Clearly, persons who are allergic to fish products should not take Imedeen, because of the danger of precipitating a fatal anaphylactic reaction.

SIDE EFFECTS OF IMEDEEN: SKIN AND SYSTEMIC

During 1993, the Netherlands Centre for Monitoring of Adverse Reactions to Drugs, reported and listed skin reactions to Imedeen ( Ned Tijdschr Geneeskd 15: 138, 2110-3,1994).

During 2005, a serious drug reaction following the ingestion of Imedeen was reported by the Inspectie voor de Gezondheidsorg, Den Haag ( Ned Tijdschr Geneekd 149:1353-6,2005. This was the development of the syndrome, (DRESS), in a 56-year-old woman taking Imedeen. This is a serious condition, potentially fatal, and caused by a wide range of drugs, including Imedeen. The syndrome is characterised by eosinophilia, lymphadenopathy and temporary liver function disorder. Bile ducts can be affected, and is therefore of interest to gastroenterologists. She recovered but was very ill and received steroids and chemotherapy ( methotrexate). Single and multiple organ dysfunctions with DRESS have been reported that include the heart, lungs liver and kidneys.

During 2006 BOLANDCELL detected ex vivo that dose-related Imedeen, incorporated in culture medium was inhibitory to human fibroblast proliferation in tissue culture. These TC observations may explain the slow clinical onset of action reported after the administration of Imedeen ( see Skovgaard et al 2006). The results of BOLANDCELL , are in contrast to the findings of Vicanova et al ( 2006). Clearly, further research is needed to determine if imedeen inhibits other cell lines, apart from fibroblasts.

Regarding efficacy, Vivida was reported to be more effective than Imedeen in the treatment of solar elastosis ( J Int Med Res 20: 227-33, 1992). Kieffer et al of Demark has demonstrated that Imedeen appears effective and safe for the treatment of the photoaged skin ( J Eur Acad Dermatol Venerol 11:129-36,1998.).

In an older study, intake of Imedeen was found to be ineffective in reversing the psychological and social problems related to the skin ( Stronks et al 1995). These results are in contrast to other reports which show benefits of topical retinoic acid, on the psychosocial correlates of treatment and photodamaged skin ( Gupta et al 1994).

ORAL FOOD SUPPLEMENTS IN THE ERA OF PHOTOLIGHT THERAPY FOR FACIAL AGING

The availability of new IPL, plasma, bidirectional radio-frequency, and lasers to treat the photo-aged skin has almost excluded the use of oral supplements. Simply because the new devices can induce rapid onset, and long lasting facial skin tightening compared to oral supplementation. Combination therapy is therefore controversial, not necessarily complementary or synergistic, but very costly. And the oral supplements take more than 6 months to show effects, if any. Oral supplementation has also the drawback of developing systemic side-effects, such as the DRESS syndrome, that is potentially fatal. See reviews on skin rejuvenation by phototherapy by Sadick et al 2005 (ELOS technology), Raulin et al 2004, and Bjerring's Group from Denmark (Lasers Surg Med 38:129-36, 2006).

It is clear that a balanced diet (including fruit and vegetables) with fibre, regular exercise, avoidance of alcohol, stress and cigarettes, together with lots of water and judicial vitamin supplementation are important. Go to top of page

 

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Boland Cell - Cell Technology - Aesthetic Biotechnology