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| TANNING NEWS |
| Link to www. volksdevil.com link to homewerx.co.uk |
| New research shows that ultraviolet light can actually shrink tumours. There is new evidence
that vitamin D-the sun vitamin -can kill tumours and stop them from growing
in the first place. We can build our own store of vitamin D in our skin by exposing ourselves to ultraviolet light. This stored vitamin D can then be activated through the winter months, or when we need it. According to studies carried out, up to half of us are deficient in vitamin D in the winter and up to 30% of us are deficient all year round. This vitamin D is activated in the breast, colon, prostate, liver, kidneys and other organs. When it is activated it stops any cancer cells from growing. Most people probably
do not even produce vitamin D in the winter months, say between November
and March because of the lack of sunshine and working indoors etc. Vitamin D also helps
the immune system, the regulation of hormones, the nervous system and
regulation of calcium levels in the blood which are vital for nerve impulse
transmission and muscle contraction. One case study by professor M. Hollick, regarded as the world's leading photo biologist, cites the UV benefits to a 61 year old woman who came to his vitamin D clinic. She was severely deficient in vitamin D and showed signs of significant bone decay consistent with osteoporosis. Her pain was so severe she could not sit down. He exposed the woman to a sunbed 3 times a week using the recommended exposure times for her skin type as set out by The Sunbed Association over a period of several months and the bone pain gradually dissapeared.
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Based on his findings he estimates that a quarter of breast cancer deaths in the UK are a result of vitamin D deficiency. There are approximately 15,000 deaths per annum from breast cancer. Dr. Jacqueline Berry
a senior research fellow from the vitamin D research group at the university
Department of medicine at Manchester Royal Infirmary has stressed the
need to not overlook the benefits of moderate sunlight for the production
of vitamin D. To summarise, here is a list of conditions that can benefit from the sun. • Osteoporosis I hope this helps to give a balanced view of sunlight, one of the four essential ingredients to human life - sun, water, air and earth. I hasten to add that only a small amount of ultraviolet light is needed to synthesise the production of vitamin D, i.e. exposing yourself to the sun, say three times a week for 10 to 15 minutes would give you the recommended RDA intake required to prevent vitamin D deficiency for skin type 3. Always adhere to The Sunbed Association's guidelines when tanning. (Copies available from Jetsun Sunbeds). Tel 07831 699433). Always be sure to look for The Sunbed Association logo when choosing a tanning studio and ask to see their training certificates. Organised by The Health Research Forum Sunlight, Vitamin D and Health House of Commons 2 Nov 2005 Host: Ian Gibson MP In order of presentation
The Miracle Vitamin D: Importance for Bone Health and Prevention of Common Cancers, Autoimmune Diseases and Cardiovascular Heart Disease Professor Michael Holick Professor of Medicine, Physiology and Biophysics; Director of the General Clinical Research Center; and Director of the Bone Health Care Clinic and the Heliotherapy, Light, and Skin Research Center at Boston University Medical Center. Adequate vitamin D nutrition is associated with the prevention of rickets in children and therefore, little thought is given about the consequences of vitamin D deficiency in adults. However, it is now becoming clear that vitamin D plays an important role in maintaining bone health from birth until death. Of equal importance is that vitamin D has a multitude of other biologic functions in the body that may be important for the prevention of common cancers, hypertension, type 1 diabetes, as well as a host of other common maladies that afflict elders. Unlike most fat soluble and water soluble vitamins that are plentiful in a healthy diet, very few foods naturally contain vitamin D. Consumption of oily fish, such as salmon or makerel, three to four times a week or ingestion of cod liver oil on a daily basis are two natural sources. Some foods such as milk and some breads and cereals are also fortified with vitamin D. However, the vitamin D content that is added to milk in the US has in the past been found to be highly variable and in some cases, absent. (Milk in the UK is not fortified with vitamin D). It is not appreciated that most of our vitamin D requirement, i.e. 80-100%, comes from our exposure to sunlight. The body has a huge capacity to produce vitamin D3. A person in a bathing suit exposed to sunlight or ultraviolet B radiation for an amount that would cause a light pinkness to the skin (1 minimal erythemal dose; 1 MED) will raise the blood levels of vitamin D3 to the same degree as if the individual took between 10,000 and 25,000 IU of vitamin D. Anything that alters the amount of ultraviolet B radiation that penetrates into the skin will have a dramatic influence on the cutaneous production of vitamin D. Increase in skin pigmentation, use of sunscreens, increase in latitude, increase in the Zenith angle of the sun due to seasonal changes, and aging all dramatically influence the cutaneous production of vitamin D3. The topical application of a sunscreen with an SPF of 8 will reduce the cutaneous production of vitamin D3 by 97.5%. Vitamin D deficiency is extremely common in the US and UK adult population. More than 50% of free living and institutionalized elders in the US have been reported to be vitamin D deficient. It has been assumed that young and middle-aged adults are not at risk for vitamin D deficiency. However, the lifestyle of the young and middle-aged adults is such that they are constantly working indoors and when outdoors they wear a sunscreen because of their concern of sun exposure and risk of skin cancer. A study in Boston reported that 32% of medical students and residents aged 18-29 years were vitamin D deficient at the end of the winter. The NHANES III study reported that 41% of African American women of child bearing age (15-49 years) were found to be vitamin D deficient at the end of the winter. Chronic vitamin D deficiency has subtle and insidious consequences for both bone health and overall health and well-being for all adults and in particular elders. Vitamin D deficiency can precipitate and exacerbate osteoporosis due to the accompanying secondary hyperparathyroidism. Vitamin D deficiency also causes osteomalacia, which is often associated with muscle pain, weakness, and bone pain, weakness and increased risk of fracture. Vitamin D is biologically inert and is metabolized in the liver to its major circulating form 25-hydroxyvitamin D [25(OH)D]. 25(OH)D is converted in the kidney to 1,25-dihydroxyvitamin D [1,25(OH)2D] that is responsible for regulating intestinal calcium absorption and stimulating osteoclastogenesis. Vitamin D receptors (VDR) are present in most tissues and immune cells in the body. 1,25(OH)2D is one of the most potent inhibitors of cellular growth. In addition, 1,25(OH)2D alters both activated T and B lymphocyte function. VDR is present in the kidney and recently it was demonstrated that 1,25(OH)2D down regulates the renin/angiotension system. It is now recognized that the kidney is not the sole source for the production of 1,25(OH)2D. Many other organ systems, including colon, prostate, breast, and skin have the enzymatic machinery to produce 1,25(OH)2D locally. This may be the explanation for why chronic vitamin D deficiency, often associated with living at higher latitudes, is associated with increased risk of dying from colon, prostate, breast, and ovarian cancer. Exposure to ultraviolet B radiation was effective in treating moderate hypertension. In animal models 1,25(OH)2D treatment was effective in preventing multiple sclerosis-like disease and type 1 diabetes. The recent observation that vitamin D supplementation of children resulted in a decreased risk of type 1 diabetes by 80% is noteworthy. There is a great need to increase our awareness of vitamin D nutritional status and its health implications. The only method to determine vitamin D status is to measure circulating concentrations of 25(OH)D. Recently, the National Academy of Sciences has recommended that vitamin D intakes be increased for elders to 600 IU/day. However, in the absence of exposure to any sunlight, this is probably inadequate. It is now estimated that 1,000 IU of vitamin D a day is required to satisfy the body’s needs and maintain circulating concentrations of 25(OH)D at least 30 ng/ml, which is thought to be important to maximize bone health and cellular health. Dr Armin Zitterman from the Heart and Diabetes Center, Ruhr University Bochum, Germany Heart disease epidemic in sun-starved Britons High levels of heart disease in Britain may be caused by insufficient vitamin D which is normally obtained by the action of sunlight on skin. The higher incidence of heart disease in Scotland compared with England, or in England compared with southern European countries such as France, Italy or Spain may be explained by relatively weak sunlight and short summers in the north. In fact the good health associated with the Mediterranean diet may be accounted for as much by the Mediterranean sun as by the regional food. Dr Armin Zitterman from the Heart and Diabetes Center, Ruhr University Bochum, Germany, argues that insufficient vitamin D causes the calcification of arteries that commonly occurs in people with heart disease. Higher levels of vitamin D produced by supplements or sun exposure prevents heart disease by reducing inflammatory processes and disorganised cell proliferation in blood vessels and in the heart, he believes. "Protection against chronic disease can be obtained in winter by taking 2000 IUs (50 micrograms) vitamin D per day. In summer, enough vitamin D can be obtained by sunbathing for 10 minutes or so in the middle of the day, exposing the whole body. This will protect against bone disease and is likely to prevent heart disease too," says Dr Zittermann. But government advice in the UK is seriously out of date and misleads the public into thinking that adults obtain sufficient vitamin D from casual exposure of hands and face to the sun. In fact very little vitamin D is obtained from casual exposure to the sun in the UK. Many people in the UK also get little vitamin D from food, especially if they do not eat margarine or oily fish and choose a wholemeal breakfast cereal such as muesli that contains no vitamin D. "Current dietary guidelines for vitamin D in the UK are incorrect in stating that adults below age fifty require no vitamin D and specify too little for older people," said Reinhold Vieth, professor of nutritional sciences in Toronto. "Sun avoidance advice makes the vitamin D problem even worse in the UK. The result is an unacceptably high occurrence of what should be regarded as toxic vitamin D deficiency." This toxic deficiency of D is associated with higher incidence of many chronic diseases. Not only heart disease but several types of cancer including cancer of the breast, prostate and bowel. Note from the editor: The high dose vitamin D supplement recommended by Dr Zittermann cannot be obtained over the counter in the UK and has to be bought (typically, over the internet) from abroad. Freeda Vitamins in New York is a reputable supplier.
Genes, Environment and Prostate Cancer risk: sunlight and Vitamin D - related genes. Professor Richard C. Strange Professor of Clinical Biochemistry, Keele University Medical School, University Hospital of North Staffordshire Inappropriate exposure to ultraviolet radiation (UVR) in sunlight is critical in development of the common skin cancers. Public Health agencies have emphasized the dangers of inappropriate exposure. By contrast, many studies show relative vitamin D deficiency throughout the world. Vitamin D is not common in nature and humans generally acquire the chemical through the actions of sunlight on skin. Biologically active vitamin D (1,25-dihydroxy vitamin D) exerts key effects on biochemical pathways and maintaining adequate vitamin D is important in determining the efficiency of tissues and risk of various diseases. The range of vitamin D-dependent diseases is potentially large as the chemical exerts effects in many cells including prostatic, colonic and breast and appears to have a key role in mediating insulin sensitivity as well as blood pressure and acute myocardial infarction risk. There is a therefore a dilemma; the incidence of skin cancer is increasing in many Caucasian populations where many individuals have low vitamin D. We hypothesised that a relative deficiency of vitamin D will increase risk of prostate cancer because of the effects of 1,25-dihydroxy vitamin D in inhibiting the growth of tumour cells as well as maintaining their differentiation. Several workers have proposed an inverse relationship between UVR and prostate cancer risk. Whilst such data are interesting they have been criticised because associations may result from unrecognised confounding factors. Data for prostate cancer shows that the mortality rate in the colder northern states of the United States is approximately twice that of the warmer southern states. We have examined the hypothesis that low UVR exposure leads to increased prostate cancer risk. We proposed that the impact of exposure is mediated by characteristics including inherited variations in the DNA sequence of key genes. We focused on genes that determine skin pigmentation, a characteristic that mediates the effects of UVR on skin. Thus, lightly pigmented skin is at relatively high skin cancer risk but is efficient in synthesising vitamin D. We hypothesise that Caucasians with lightly pigmented skin (skin type 1) are at lowest risk of prostate cancer. We propose that this association was mediated by genetic factors particularly those that determine skin pigmentation. In our first studies we recruited 210 prostate cancer cases and as controls, 155 men with benign prostatic hypertrophy. We asked the men to record aspects of their lifetime UVR exposure. The proportion of cancer cases with very low levels of exposure was markedly higher than the proportion of men with benign prostatic hypertrophy. Other exposure parameters including sunbathing, regular holidays in a hot climate and sun burning were all associated with reduced risk of the cancer. Because this initial study comprised a relatively small number of men we recruited further cancer cases and men with benign prostatic hypertrophy, repeated the initial investigation and obtained virtually identical results. This shows that in northern European men, low levels of UVR exposure are linked with increased prostate cancer risk. As predicted, skin type 1 conferred reduced prostate cancer risk particularly in men with low exposure. Further, inherited variation in genes that mediate pigmentation such as MC1R and TYR are linked with cancer risk. Whilst these findings do not prove the hypothesis they are supporting. Genes linked with the handling of vitamin D are also strong candidates for risk. Thus, the vitamin D receptor, the gene that mediates the biological actions of 1,25-dihydroxy vitamin D demonstrates many inherited variants in its gene sequence and some are linked with prostate cancer risk. The hypothesis that prostrate cancer risk is mediated by exposure to sunlight is compatible with the known influences of vitamin D on key biological processes. There are data showing associations between exposure, skin type, relevant genes and disease risk. However, caution is required in using these data to derive public health advice. Encouraging people to increase exposure maybe inappropriate if we are not yet sure what levels of exposure are most significant in increasing skin cancer risk. Indeed, advice may need to be tailored to individual characteristics such as level of pigmentation or ability to initiate a pigmentary response to sunlight. It is reasonable to state that these data are interesting and worthy of investigation since the potential public health benefits are huge.
Professor Johan Moan, Institute for Cancer Research, Oslo, Norway Cancer risk reduced by vitamin D and sunbathing Diseases caused by insufficient vitamin D include not only bone conditions such as osteoporosis and rickets but high blood pressure, diabetes, multiple sclerosis and probably several different kinds of cancer. Exposure to summer sun improves survival from cancer according to Professor Johan Moan of the Institute for Cancer Research in Oslo, Norway, who has studied what happened to all the people diagnosed with cancer in Norway between 1964 and 2000. He found that the risk of a person dying within three years of diagnosis with prostate, breast, colon, or lung cancer, or with Hodgkins lymphoma is up to 50 per cent lower for those diagnosed during summer and autumn compared with winter. "In Nordic countries, and in Britain, practically no vitamin D is generated in the skin during the winter months because solar radiation contains too little ultraviolet B," says Professor Moan. "In summer, calcidiol, a form of vitamin D that circulates in blood, is up to 100 per cent greater than in winter. It seems likely that calcidiol protects against these cancers. We have also found that the risk of death from cancer varies in Norway from one part of the country to another, depending on the amount of solar radiation that is received." In the UK the risk of getting prostate cancer has also been found to vary with the amount of sun a man is exposed to. Men who sunbathe, have holidays in sunny climates and those who have suffered from sunburn have a lower risk of prostate cancer. (In these observations sunburn is simply a sign of heavy sun exposure. Burning should be avoided because it carries a risk of skin cancer). "A lower level of exposure to UV light is linked to increased risk of prostate cancer in northern European men. Men with the lightest skin type, fair with freckles, have the least risk of prostate cancer, presumably because they are able to make use of the weakest sunlight to produce vitamin D," says Professor Richard Strange from Keele University Medical School, Staffordshire. "I used to cover up and use suncream when I went out walking in the hills but now I don’t. I try to get as much sun as I can safely," he says.
Multiple sclerosis – evidence that insufficient sunlight is a cause of MS Professor George Ebers Action Research Professor of Neurology in the Department of Clinical Neurology at the University of Oxford MS: an environmental factor There are powerful environmental factors operating in the determination of MS risk, first quantified after the First War. US veterans with MS were proportionately more from the north. Recent studies allow greater focus. In Australia, a 6-fold difference in risk is present between Tasmania and Queensland. The familial microenvironment A geographical gradient occurs in the context of several lines of evidence demonstrating that familial micro-environment appears to play no role in MS risk. These come from studies of adoptees, twins, half-sibling, conjugal pairs, step-siblings and consanguineous matings. In all of these studies, risk is attributable to biological rather than environmental relatedness. The inescapable conclusion is that the environmental factors must act at a broad population level, leaving climate and diet as two obvious candidates. Since diet tends to be familial, some direct or indirect effect of climate is much favoured. Latitude and MS National studies in MS capable of evaluating the question have found latitude to be the most important environmental associate of risk. Four decades ago it was first suggested that MS risk was related to sunlight exposure. This remains increasingly viable based upon the serial exclusion of other proposed mechanisms. Sunlight could influence a variety of biological processes. Timing of effect is uncertain. Gestation and the time of birth Four specific features seem to point to a role for environment in early development. These include an increased risk for dyzygotic twins compared to siblings, a month of birth effect in MS and a maternal effect which appears to be environmental and gestational and is derived from the study of halfsibs. There may be reduced risk for dyzygotic twins again pointing to shared uterine environment. Plausibility of sunshine/vitamin D Its plausibility in MS has always suffered from a credibility gap. What do sunlight and/or Vitamin D have to do with the immune and nervous systems? The plausibility gap between vitamin D being the key environmental exposure and a role for this hormone in the nervous system has recently been closed. Vitamin D receptors are diffusely expressed throughout the brain and gestational Vitamin D deficiency is associated with gross maldevelopment of the nervous system. It is timely to give consideration to a potential role of sunlight and Vitamin D in preventing MS which is probably increasing in incidence. How much vitamin D is enough for optimum health Professor Reinhold Vieth Professor in the Department of Nutritional Sciences and the Department of Laboratory Medicine and Pathobiology, University of Toronto. Modern humans first appeared 100,000 years ago, effectively designed through evolution to live in a warm, sunny climate. The UK is so far north that vitamin D produced in summer must sustain us through a five month vitamin D winter without suitable sunlight. Current dietary guidelines for the UK are incorrect in stating that adults below age fifty require no vitamin D. For older adults, official UK guidelines specify only half the minimum intake that doctors now recommend to prevent fractures. Sun-avoidance advice makes the vitamin D problem even worse. The result is an unacceptably high occurrence of what should be regarded as toxic vitamin D deficiency. This is associated with higher incidence rates of breast, prostate and bowel cancers. When these cancers do occur vitamin D deficiency increases mortality rates. Vitamin D deficiency accelerates bone loss, promoting osteoporosis and bone fractures. Vitamin D deficiency causes muscle weakness, and impairs ability to balance, this increases falls in the elderly. Vitamin D deficiency increases risk of both juvenile and adult-onset diabetes. Vitamin D supplementation is safe, and essential to health. Official UK guidelines about vitamin D need to be re-evaluated and revised to allow the public to benefit from the wealth of research findings about this nutrient.
Professor Brian Diffey, Professor of Medical Physics at Newcastle University Caution urged on sun exposure At the meeting the sceptical view presented by Brian Diffey, professor of medical physics at Newcastle University, who is an adviser to Cancer Research UK, which devised the SunSmart approach. He believes that evidence remains insufficient to advocate a public health policy of deliberate sun exposure as a means of reducing chronic disease, especially cancer. "We receive more than enough sun exposure during recreational activities," he says. "Public health messages that make patients feel blameworthy that their cancer may be self-imposed, for example by not getting enough sunlight, need a strong evidence base. Any compromise on the key messages in the UK SunSmart programme could lead to more cavalier behaviour resulting in an even greater adverse impact on skin cancer incidence and mortality with no resulting benefit seen in other cancers."
Dr Elina Hypponen, a researcher at the Institute for Child Health, London. Sunshine vitamin prevents early diabetes Children who are given supplements of cod liver oil or vitamin D are less likely to develop diabetes early in life, according to Dr Elina Hypponen, a researcher at the Institute for Child Health, London. Breast fed infants are most at risk of vitamin D deficiency, and perhaps diabetes, because milk from mothers living in the UK contains little vitamin D. Artificial baby milks are supplemented with vitamin D and so bottle fed babies are not at risk until after weaning. Babies whose mothers come from ethnic minorities are also at greater than average risk because of their mother’s lower vitamin D levels. Most vitamin D in the body comes from the action of sunlight on skin and many mothers in Britain obtain little exposure to sunlight because of our cloudy northern climate. Black people have lower levels of vitamin D because dark skin makes less vitamin D in a given time. A quarter of white British people aged 44-45 and more than half of people from ethnic minorities aged 44-45 living in Britain obtain insufficient vitamin D for good health, according to as yet unpublished figures from UK National Child Development Study compiled by Dr Hypponen. Dr Hypponen, who is Finnish, has a baby of her own aged six months. She says: "I have been unable to find any suitable products here in the UK, and so I am giving vitamin drops to my baby that I obtained in Finland. There is a need to form appropriate vitamin D supplement recommendations for breast fed babies in the UK, and to ensure that suitable products are available." Babies at risk because NHS vitamin drops withdrawn Background: Until 1975 infants in the UK were given free NHS vitamin drops containing vitamin D. But subsequently the vitamin drops, which were considered to be a "welfare food", were given only to mothers on benefits. In fact not only breast fed infants but all infants after weaning need a vitamin D supplement for optimal health. (Artificial baby milk is fortified with vitamin D.) In the past mothers who were not entitled to free NHS infant vitamin drops could buy them, but the government never promoted them properly and so uptake gradually fell. Now NHS vitamin drops are no longer available because there was a problem with leakage from the bottles and all stock had to be withdrawn. Paediatricians have been pressing for government action to replace the defective product but have been unsuccessful. Doctors in Birmingham, frustrated by government inaction, have launched a scheme to provide a vitamin D supplement for babies under one year and for pregnant or lactating mothers. It is paid for by the local Primary Care Trust.
Dr. Oliver Gillie New foods and better sun advice could curb heart disease and cancer The meeting also looked at what measures can be taken to enable British people to obtain more vitamin D. The sunshine vitamin is now thought to protect not only against bone disease such as osteoporosis but also against heart disease and several types of cancer. Calling for government action to overcome the problem of insufficient vitamin D in the UK, Oliver Gillie, a director of Health Research Forum, a not-for-profit organisation which organised the meeting, said: "The solution is simple compared with persuading people to give up smoking or lose weight, and could have a dramatic effect in reducing chronic disease. More foods need to be fortified with vitamin D so the public can, if it wants, choose foods such as bread, milk, butter and cooking oil that contain the vitamin. "Official advice on sun exposure needs to be changed. Sadly, the government-backed SunSmart programme, which aims to prevent skin cancer, may have caused more deaths from other cancers than it has prevented from skin cancer. Far from avoiding sunlight in the UK in the middle of the day, which prevents us from getting enough vitamin D, we should follow the SunSafe advice, presented here for the first time. "The SunSafe advice aims to encourage people to expose themselves to the sun safely and raise their vitamin D levels, without burning and with minimum risk of skin cancer. A tan is entirely natural and a sign of good health." The SunSafe advice has been specially designed for the UK, whereas the SunSmart advice was designed originally for the sun-drenched Australian climate. SunSafe advice followsThe SunSafe Advice – "Safe and Smart" In sun-starved northern latitudes such as the UK you should: 1. Sunbathe safely without burning, every day if you can. 2. The middle of the day is a good time for sunbathing in the UK. 3. Start by sunbathing for 2-3 minutes each side. Gradually increase from day to day. 4. Don’t use "sun protection factor" cream while sunbathing. 5. If feeling hot or uncomfortable expose a different area, cover up, move into the shade, use SPF suncream or sunblock. 6. When abroad, where the sun is generally stronger, expose yourself for shorter times than at home until you find out how much is safe. 7. Children benefit from sun exposure, but need guidance. 8. A tan is natural and is generally associated with good health. The SunSafe advice was presented by Oliver Gillie, a director of Health Research Forum, see above for explanation. the dangerous facts of using this drug You can report anyone selling or advertising Melanotan anonymously to the MHRA information Centre on 020 7084 2000. The most important fact that these sellers of melanatan are not telling you the public is that your body does not synthesise Vitamin D,this crucial vitamin that a lack of in the uk is directly responsible for killing 20,000 people every year.The only true and natural way to get this vitamin is thru ultraviolet light. FDA Drug agency warnings In 2007, the FDA issued a warning to an American vendor illegally marketing melanotan II on the internet as a drug that prevents skin cancer and assists tanning. The FDA has not licensed melanotan II, and explained: "There is no evidence that the product is generally recognized as safe and effective [GRAS/E] for its labeled uses." On August 8, 2008 the Danish Medicines Agency (DMA) issued a warning against the usage of Melanotan purchased on the internet, noting that claims that imply that it has an, "effect" for protection against skin cancer, "has not been documented". The DMA further warned that Melanotan has not undergone tests for its effect and possible side effects, and that it is not licensed for usage in the EU or the USA. The UK Medicines and Healthcare products Regulatory Agency issued a similar warning on November 17th 2008 stating that "We are warning people not to use this product. Don’t be fooled into thinking that Melanotan offers a shortcut to a safer and more even tan. The safety of these products is unknown and they are unlicensed in the UK. The side effects could be extremely serious. If you have used either of these products do not use them again and if you have any concerns you should seek advice from your doctor.” FDA Warns About Unapproved Product, Melanotan IIFDA is advising consumers to stop using Melanotan II, an unapproved product. Melanotan II is being advertised as a tanning agent, with additional claims of being effective in protecting against skin cancer and rosacea (a flushing and redness of the skin). At the same time, consumers are advised to consult their health care providers if they have experienced any adverse side effects they suspect are related to using the product. The agency also has issued a Warning Letter to the owner of the company, who is illegally selling and marketing Melanotan II from his Web site. Or any other seller. Problems with Melanotan II
Consumers and health care providers should notify FDA Press release Date: 17 November 2008 Time: 10.00am Subject: Melanotan Contact: Press Office 020 7084 3564 / 3535 press.office@mhra.gsi.gov.uk Out of hours 07770 446 189 _________________________________________________________________ “Tan jab” is an unlicensed medicine and may not be safe - warns medicines regulator The Medicines and Healthcare products Regulatory Agency (MHRA) is warning people not to use an unlicensed medicine called Melanotan which is being advertised and sold illegally as an injectable tan on the Internet and in some tanning salons and body building gyms. Melanotan has not been tested for safety, quality or effectiveness. Therefore it is not known what the possible side effects are or how serious they could be. People should be aware of this should they be offered the product. There are two types of Melanotan - Melanotan I and Melanotan II. They work by increasing the levels of melanin which is the body’s natural protection from the sun, resulting in a suntan. Both products are self-injected, which means there are serious needle safety issues to consider, such as the prevention of cross-contamination and infections. David Carter, Head of the Medicines Borderline Section at the MHRA said; ‘We are warning people not to use this product. Don’t be fooled into thinking that Melanotan offers a shortcut to a safer and more even tan. The safety of these products is unknown and they are unlicensed in the UK. The side effects could be extremely serious. If you have used either of these products do not use them again and if you have any concerns you should seek advice from your doctor.” Notes to editors
1. Melanotan has to be diluted with Bacteriostatic Water (a prescription-only medicine) before it can be then self-injected into the skin. Often the product is in its concentrate state; however, the MHRA has seen some websites offering to reconstitute the product prior to sending it to the consumer. In the UK, there are licensed water products for the injection of medicine, including Bacteriostatic Water.
2. You can ask your GP to complete a yellow card which will report the adverse reaction to the MHRA, or alternatively you can submit a report directly to the
MHRA using the Yellow Card Scheme website address www.yellowcard.gov.uk
3. Needles used to inject could also carry bodily fluids, which can pass infections such as HIV and Hepatitis on to other people. Therefore, you should never re-use or share needles. If you feel that a needle has been shared, you should and can get advice on what you can do and where you can go for support. You can speak with your GP, or you can call NHS Direct on 0845 4647.
4. The MHRA has currently contacted 18 different companies explaining that any supplying or advertising of Melanotan is illegal and any websites etc should be taken down. You can report anyone selling or advertising Melanotan anonymously to the MHRA information Centre on 020 7084 2000.
5. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone –the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk
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