No evidence of supply or harm to patients
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (18 October 2023) confirmed that pre-filled pens falsely labelled as the diabetes medicine Ozempic (semaglutide, 1 mg, solution for injection) have been identified at two UK wholesalers. All affected pens have been recalled and accounted for, and none of the pens have been supplied to UK patients.
Following investigation, the MHRA has confirmed that the products, under the brand name Ozempic, were brought in from legitimate suppliers in Austria and Germany.
The MHRA is working closely with its regulatory partners internationally to continue to maintain the security of the wider supply chain, both at home and abroad.
While the falsified pens appeared to have authentic German packaging, there are substantial differences compared with genuine pens. The German medicines agency, the Federal Institute for Drugs and Medical Devices (BfArM), have published photos of the genuine and falsified products.
There is no evidence that any of the falsified pens have been dispensed to patients from legitimate pharmacies or healthcare professionals in the UK and there are no reports of harm to patients in relation to these pens.
Dr Alison Cave, MHRA Chief Safety Officer said:
We work closely with global regulatory partners to ensure that the medicines supply chain in the UK is kept secure, to keep patients safe. Patients can be assured that the products they use are genuine when accessed through legitimate sources.
Buying semaglutide from illegally trading online suppliers significantly increases the risk of getting a product which is either falsified or not licensed for use in the UK.
Products purchased in this way will not meet our strict quality and safety standards, and taking such medicines may put your health at risk.
Anyone who suspects that they’ve had an adverse reaction to semaglutide or any other medicinal product, are worried about its safety or effectiveness, or suspect it is not a genuine product, should report it to our Yellow Card scheme
Notes to Editors
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.
The MHRA is an executive agency of the Department of Health and Social Care.
Ozempic (semaglutide) has been approved by the MHRA for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. It is not authorised for weight loss, but it is commonly used off-label for that purpose.
The MHRA continuously work with national and international partners to prevent falsified medicines from entering the UK. MHRA’s #FakeMeds campaign provides quick and easy tools to help the general public avoid fake and substandard medical products.
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.
For media enquiries, please contact the newscentre@mhra.gov.uk.