Ozempic▼(semaglutide) and Saxenda (liraglutide): vigilance required due to potentially harmful falsified products
Falsified, potentially harmful Ozempic▼ and Saxenda products have been found in the UK.
We ask healthcare professionals to remind patients using these products to always obtain prescription medicines from a qualified healthcare provider and not to use products they suspect are falsified as this may lead to serious health consequences. We also ask healthcare professionals to remain vigilant for symptoms linked to hypoglycaemia in patients who may have obtained a falsified product containing insulin.
Advice for healthcare professionals:
- be aware that falsified Ozempic and Saxenda products have been found in the UK, including falsified pens containing insulin, which may lead to patient harm
- remain vigilant for symptoms linked to hypoglycaemia in patients who may have obtained a falsified product and provide appropriate treatment for any patient who may have inadvertently administered insulin via these products
- if you encounter a suspected falsified product, quarantine it and report to the Yellow Card scheme
- advise patients who are concerned that the pens they have purchased might be falsified that they should not use the pens and report as mentioned above
- Ozempic and Saxenda from legitimate supply chains are unaffected
Advice for healthcare professionals to give to patients and the public:
- you must not use Ozempic and Saxenda products or pens that you suspect are falsified as this may lead to serious health consequences
- check the Patient Information Leaflet for Ozempic and Patient Information Leaflet for Saxenda to clarify what the genuine pens look like. Do not use any products that appear suspicious – an example image of a fake Ozempic pen is available in the MHRA’s advice to the public
- falsified Ozempic and Saxenda pens may contain insulin – seek urgent medical attention if you experience symptoms of low blood sugar, which includes feeling dizzy, sweating or blurred vision; take the suspected fake medicine with you so your doctors know what may have caused this
- if more severe symptoms of low blood sugar occur, such as seizures (fits) and loss of consciousness, call 999 immediately
- If obtaining a private prescription (from a non-NHS prescriber), ensure that this is from authorised sources, such as registered online pharmacies, to avoid the risk of receiving falsified pens
- report suspected falsified Saxenda or Ozempic pens to the MHRA’s Yellow Card scheme
Background
Saxenda (liraglutide) is indicated for weight management in adult patients with obesity or people who are overweight and have at least one weight-related comorbidity. Ozempic (semaglutide) has been authorised for the treatment of adults with insufficiently controlled type 2 diabetes mellitus. Ozempic is not authorised for weight loss, but is used off-label for that purpose.
We remind healthcare professionals of the advice in the National Patient Safety Alert of July 2023 and a letter to healthcare professionals on actions to mitigate the supply shortage caused by an increase in demand for these products for licensed and off-label indications.
Seizures of falsified products
Up to October 2023 the MHRA has seized 369 potentially falsified Ozempic pens. None were seized before January 2023. We have also received reports of falsified 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).
We ask healthcare professionals to remind patients and the public to only obtain prescription-only medicines from legal pharmacies and with a prescription from a qualified healthcare professional.
With any medicines bought outside of the legal supply chain, the contents may not match the ingredients on the label. Pens containing insulin, which have been relabelled as Ozempic, have been intercepted in the UK.
All pharmacies in Great Britain, including those online, must be registered with the General Pharmaceutical Council (GPhC) and meet their standards for registered pharmacies.
Advise patients that the legitimacy of a pharmacy can be verified by referring to the GPhC website pharmacy registry and checking that the pharmacy is listed there.
The MHRA’s FakeMeds website also provides tools and resources to direct patients to.
Reports of harm
Up to 20 November 2023, the MHRA has received 16 reports to the Yellow Card scheme of the purchase or use of products supposedly containing semaglutide or liraglutide products that were suspected to be falsified. Some of these reports have now been confirmed as falsified medicines.
Five cases reported that the Saxenda and Ozempic pens were confirmed to be falsified with insulin. Some of the recipients were hospitalised and required urgent care. Serious side effects reported in those hospitalised, including hypoglycaemic shock, indicate that the pens may contain insulin rather than semaglutide.
Reporting concerns and side effects
Healthcare professionals, patients and the public can report suspected falsified products to the Yellow Card scheme. Please include in the report as much detail as possible, including if any side effects were experienced following consumption.
Healthcare professionals should quarantine suspected falsified products and retain the product for testing.
Ozempic is a black triangle medicine and therefore all suspected adverse reactions, even those with the legitimate licensed product, should be reported via the Yellow Card scheme.
Please include in the report as much detail as possible, particularly if a side effect continued or started after treatment was stopped. Information about medical history, any concomitant medication, onset timing, treatment dates, and product brand name should also be included.
Report to the Yellow Card scheme electronically using:
- the Yellow Card scheme website
- the Yellow Card app; download from the Apple App Store or Google Play Store
- some clinical IT systems for healthcare professionals (EMIS, SystmOne, Vision, MiDatabank, and Ulysses)
Article citation: Drug Safety Update volume 17, issue 4: November 2023: 1.