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Press release: "Tan jab" is an unlicensed medicine and may not be safe - warns medicines regulator

Press release

Date: 17 Nov 2008
Time: 10:00
Subject: Melanotan
Contact: Press Office 020 3080 7651
or press.office@mhra.gsi.gov.uk
Out-of-hours 07770 446 189

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 Editor

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

Page last modified: 17 November 2008