The MHRA has urged patients to only access weight-loss medicines via a medical prescription, after fake and potentially harmful Ozempic and Saxenda pens were found in the UK.
The regulatory agency said it received reports of ‘a very small number of people’ who have been hospitalised after using ‘potentially fake’ weight-loss pens.
It has seized 369 potentially fake Ozempic (semaglutide) pens since January, and has also received reports of fake Saxenda (liraglutide) pens that have been obtained by patients in the UK through non-legitimate routes.
Saxenda is authorised in the UK for weight loss, with diet and exercise, while Ozempic 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.
An MHRA spokesperson said: ‘Buying prescription-only medicines online without a prescription poses a direct danger to health.
‘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.’
MHRA chief safety officer Dr Alison Cave 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.’
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 people’s health at risk.
‘The medical advice is clear: patients should only use medicines like Ozempic or Saxenda where they’ve 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.’
Earlier this year, the RCGP warned that unregulated use of semaglutide is posing ‘a genuine threat to patient safety’ because it is causing shortages for diabetes patients.
Wegovy, a semaglutide drug for weight loss, became available via the NHS in Septamber, after a limited stock was earmarked to fulfil new NICE guidance.
In August, its manufacturer Novo Nordisk said the drug could also reduce risk of cardiovascular events by 20% but researchers have recently warned that drugs like semaglutide are associated with increased risk of gastrointestinal problems when used for weight loss.