Insulin has been found in fraudulent Ozempic and Saxenda injection pens, the Medicines and Healthcare products Regulatory Agency (MHRA) announced last week (November 23).

The MHRA said that it had confirmed five reports of fake Ozempic (semaglutide) or Saxenda (liraglutide) pens that had been filled with insulin instead of the weight-loss phenomenon drugs.

It added that in “some” of these cases, people had been hospitalised and that urgent care was needed as patients experienced hypoglycaemic shock among other “serious side effects”.

Read more: Fake Ozempic jabs injected into UK supply chain, medicines watchdog warns

The medicine safety agency said that up to November 20 this year, it had received 16 reports of semaglutide or liraglutide products that were “suspected” to be fake through its Yellow Card scheme. 

It added that it had confirmed “some” of these reports about falsified Ozempic and Saxenda pens.

The MHRA said that it had also “intercepted” injection pens that contained insulin but had been “relabelled as Ozempic” in the UK.

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Ozempic is a “black triangle” medicine, which means that it is “particularly closely” monitored by regulatory authorities, it added.

And it said that it had received reports of falsified Saxenda pens obtained by members of the UK public “through non-legitimate routes”.

It stressed that Ozempic and Saxenda pens from “legitimate” supply chains are “unaffected”.

 

Suspected fakes seized

 

Last month, C+D reported that counterfeit Ozempic injection pens had been intercepted at two UK wholesalers. 

The MHRA said at the time that all the counterfeit pens had been “recalled and accounted for” and that it had received “no reports of harm to patients” in relation to them.

It added that its information suggested that there were no other falsified products at "licensed UK companies".

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In its statement last week, the MHRA revealed that it had seized 369 “potentially falsified Ozempic pens” in 2023 so far by October.

The MHRA advised health professionals that they should “quarantine”, report and retain for testing any products that they suspect are “falsified”. 

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It urged them to “remind” patients that they should only access prescription medication from “legal pharmacies and with a prescription from a qualified healthcare professional”.

And it said that they should “remain vigilant for symptoms linked to hypoglycaemia in patients who may have obtained a falsified product containing insulin”.

 

Novo Nordisk “aware”

 

Ozempic and Saxenda injection pen manufacturer Novo Nordisk said that it had been “made aware” of counterfeit pens being “distributed through the legal supply chain and illegal channels in the UK”.

A spokesperson told C+D yesterday (November 27) that some of the counterfeit pens can be identified by differences in “the scale indicator” and “dose selector” compared to the original products, but stressed that “counterfeits can vary”.

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The spokesperson said that these pens “pose a risk to patient safety” since they may not contain genuine semaglutide or liraglutide.

They said that Novo Nordisk is in “close dialogue with local health authorities” about fake medicines, adding that it is working with a “third party” to investigate and remove “illegal online offers” as well as conducting physical investigations on the ground to identify and the report illicit manufacturers.

“We will always put patient safety first and are committed to continue to actively fight against counterfeit products,” they said.