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Melanatan

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 melanatan II on the internet as a drug that prevents skin cancer and assists tanning. The FDA has not licensed melanatan 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 Melanatan 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 Melanatan 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, Melanatan II

FDA is advising consumers to stop using Melanatan II, an unapproved product. Melanatan 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 Melanatan II from his Web site. Or any other seller.

Problems with Melanatan II

                               Claims being made cause the product to be classified as both a drug and a new drug, under the Federal Food, Drug and Cosmetic Act.

                               However, the product does not have an approved new drug application.

                               There is no evidence that the product is generally recognized as safe and effective for its labeled uses.

                               Product's introduction and delivery into interstate commerce violates federal law.

                Risks run by patients who use unapproved new drugs could include adverse side effects from inappropriately prescribed medications, dangerous drug interactions, and harm from contaminated, counterfeit or outdated drugs.

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. Melanatan 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 Melanatan - Melanatan I and Melanatan 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.

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.

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 Melanatan 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. Melanatan 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 Melanatan 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

http://www.vitamindcouncil.org/