The medicines watchdog confirmed yesterday (October 18) that pre-filled semaglutide 1mg pens “falsely labelled as the diabetes medicine Ozempic” have been identified at two UK wholesalers.

However, all of the counterfeit pens have been “recalled and accounted for” and the MHRA has received “no reports of harm to patients” in relation to them, it said.

Ozempic is a prescription medicine that can be injected weekly alongside diet and exercise to improve the blood sugar of those with type 2 diabetes.

The MHRA said there was “no evidence” that the falsified pens had been dispensed by “legitimate pharmacies or healthcare professionals” to patients in the UK.

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It added that an investigation had revealed the pens were “brought in” by “legitimate suppliers” in Germany and Austria, which it did not name. 

An MHRA spokesperson told C+D that the watchdog had "contained the incident". The MHRA's information suggested that there were no other falsified products at "licensed UK companies", they said.

The medicines watchdog continues to "work closely" with international agencies, sharing information to "maintain the security of the wider supply chain, both at home and abroad", the spokesperson added.

 

Faux-zempic

 

The MHRA pointed to “substantial differences” in the fake Ozempic pens, which appeared to be in “authentic German packaging”, compared to legitimate injections pens.

Photos supplied by the German medicines agency, the Federal Institute for Drugs and Medical Devices (BfArM), show that the falsified pens look significantly different to legitimate Ozempic pens.

Ozempic manufacturer Novo Nordisk told C+D that the contents of counterfeit injection pens "can be entirely different from the genuine medicine". They "should not be used, as they pose a risk to patient safety", it warned.

Read more: Boots, Superdrug and Well line up to offer private Wegovy weight loss jabs 

The manufacturer said that some falsified injection pens it has been made aware of "can be identified by the scale indicator and the dose selector, which differ from the genuine product". However, "counterfeits can vary", it stressed. 

Novo Nordisk urged anyone who "suspects their medicine is not a genuine product" reports it to the MHRA's yellow card scheme and also to the manufacturer's own customer care centre by calling 0800 023 2573. 

Meanwhile, MHRA chief safety officer Dr Alison Cave said that patients "can be assured that the products they use are genuine when accessed through legitimate sources". 

However, "buying semaglutide from illegally trading online suppliers significantly increases the risk of getting a product that is either falsified or not licensed for use in the UK", she warned.

 

“Inactive” serial numbers

 

Yesterday (October 18), the European Medicines Agency (EMA) issued an EU-wide alert that the fake Ozempic pens had been found at wholesalers in the EU and the UK.

The EMA said that the authorities were alerted to the counterfeit pens when the packages were scanned and showed “inactive” serial numbers. It said that the fake pens had “batch numbers, 2D barcodes and unique serial numbers” from genuine Ozempic packaging.

Read more: Pharmacies pioneer private Wegovy service as drug sees UK launch

Ozempic, like the blockbuster weight-loss drug Wegovy, is produced by Novo Nordisk and contains the active ingredient semaglutide. 

C+D has approached Novo Nordisk for comment.

Unlike Wegovy, Ozempic is only “indicated for the treatment” of adults with type 2 diabetes, and not for weight-loss, according to a February Novo Nordisk letter reporting a supply shortage in the UK.

Read more: DH and MHRA ban wholesalers from exporting or hoarding semaglutide

In September, Wegovy was introduced in the UK in a “controlled and limited launch”. The semaglutide injection could be accessed by eligible patients in specialist NHS weight management services and privately through “a registered healthcare professional”, Novo Nordisk said at the time.

In June, the Department of Health and Social Care (DH) and the MHRA included semaglutide on the list of medications that wholesalers are prevented from exporting or hoarding.