Department Of Health
The Medicines and Healthcare products Regulatory Agency (MHRA) is warning the public not to buy pre-filled pens claiming to contain Ozempic (semaglutide) or Saxenda (liraglutide) but to consult a healthcare professional qualified to prescribe medicines and obtain a prescription.
Semaglutide and liraglutide are prescription only medicines.
Saxenda (liraglutide), is authorised in the UK for weight loss, with diet and exercise. Ozempic (semaglutide) has been authorised for the treatment of adults with type 2 diabetes, also with diet and exercise. It is not authorised for weight loss, but it is commonly used off-label for that purpose.
The MHRA has seized 369 potentially fake Ozempic pens since January 2023, and has also received reports of fake Saxenda pens that have been obtained by members of the public in the UK through non-legitimate routes (any route that does not require a prescription from a qualified prescribing healthcare professional). None were seized before January 2023.
Buying prescription-only medicines online without a prescription poses a direct danger to health. The MHRA has received reports of a very small number of people who have been hospitalised after using potentially fake weight-loss pens.
With any medicines bought outside of the legal supply chain, the contents may not match the ingredients on the label. Serious side effects reported of those hospitalised, including hypoglycaemic shock and coma, indicate that the pens may contain insulin rather than semaglutide.
If anyone has a concern about their health, they should visit their GP or pharmacist, get a correct diagnosis and if medicines are prescribed, obtain them from a legitimate source.
All pharmacies in Great Britain, including those online, must be registered with the General Pharmaceutical Council (?GPhC) and meet their standards for registered pharmacies.??
Dr Alison Cave, MHRA Chief Safety Officer said:
Buying products such as Ozempic or Saxenda without a prescription, from illegally trading suppliers, significantly increases the risk of receiving something which is either fake or not licensed for use in the UK.
Products purchased in this way do not meet our strict quality and safety standards, and taking such medicines may put your health at significant risk.
We are advising all members of the public not to use any pre-filled weight loss pens they may have bought online and instead to report it to us so that we can investigate and take any necessary action.
If you suspect that youve had a side effect to semaglutide, liraglutide or any other medicine, or suspect its not a genuine product, you can report it to our Yellow Card scheme.
Health Minister Will Quince said:
No one should put profit before the needs of patients, but fraudsters selling black market medicines like this are extremely dangerous and can put peoples health at risk.
The medical advice is clear: patients should only use medicines like Ozempic or Saxenda where theyve been prescribed it by a legitimate source, such as their GP or another legitimate prescriber.
The MHRA have our full support in cracking down on these illegal online suppliers to ensure that patients are protected.
Professor Paul Gately, CEO of Obesity UK, said:
We at Obesity UK are very concerned to hear reports that people living with obesity are falling victim to criminals who are obtaining and selling fake weight loss medication.
The dangers to health are clear. Our advice, like that of the MHRA, is that only medication prescribed by a qualified medical/healthcare professional should be taken.
Find out more
MHRA safety advice when buying medicines online
Be careful when buying medicines online
Medicines are not ordinary consumer goods and their sale and supply is tightly controlled. Websites operating outside the legal supply chain may seem tempting, for example, offering a prescription medicine without a prescription. Not only are these sites breaking the law theyre putting your health at risk.
Criminals use a variety of techniques to sell medicines illegally online. Some are sold using websites designed to look like legitimate pharmacies or online retailers, while others might be advertised via online marketplaces or social media sites.
Visit the #FakeMeds website?for tools and resources to help people purchase medicines or medical devices safely online.
Notes to editors?
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Semaglutide and liraglutide are examples of GLP-1 (glucagon-like peptide-1) receptor agonists, medicines that are used to treat type 2 diabetes and help manage weight. They are available as injections, often referred to as pens or jabs.
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Off-label prescribing is when a product is prescribed for use outside the terms of its licensed use, including for a different indication and/or to a different patient population. As stated in MHRA guidance, this is allowed in clinical situations when the use of unlicensed medicines or use of licensed medicines outside the terms of the licence (i.e. off-label) may be judged by the prescriber to be in the best interest of the patient on the basis of available evidence. In these situations, the prescriber has additional responsibilities regarding information to the patient and recording treatment (see GMC guidelines).?
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If a product is captured under the definition of a medicinal product contained within the Human Medicines Regulations 2012, it must hold a Marketing Authorisation to be legally sold or supplied in UK.
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The MHRA continuously works with national and international partners to prevent fake medicines from entering the UK. Its #FakeMeds campaign provides quick and easy tools to help the general public avoid fake and substandard medical products.
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The Yellow Card scheme enables the MHRA to monitor safety concerns such as suspected side effects or adverse incidents involving healthcare products. These include medicines, vaccines, blood factors and immunoglobulin products, medical devices, e-cigarettes and complementary therapies such as homeopathies. The scheme also collates information about suspected safety concerns involving defective, falsified or fake healthcare products. Anyone can report defective or fake healthcare products to the Yellow Card scheme via the Yellow Card scheme website or app.
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For media enquiries, please contact the newscentre@mhra.gov.uk or call on 020 3080 7651
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.? All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.?
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The MHRA is an executive agency of the Department of Health and S