European regulator warns EU, UK about fake Ozempic pens

(Reuters) -Europe's medicines regulator on Wednesday warned about pre-filled pens falsely labelled as Novo Nordisk's popular diabetes drug Ozempic at wholesalers in the European Union and the UK.

"There is no evidence that any falsified pens have been dispensed to patients from legal pharmacies and there are no reports of harm to patients in relation to the falsified medicine," the European Medicines Agency (EMA) said.

Its UK counterpart, the Medicines and Healthcare products Regulatory Agency (MHRA), confirmed that falsely labelled pens of Ozempic have been identified at two UK wholesalers.

Novo became one of Europe's most valuable companies this year on surging demand for its weight-loss drug Wegovy and diabetes drug Ozempic amid a global obesity crisis.

Though only Wegovy is approved for obesity, the fact that Ozempic also leads to dramatic weight loss has led people in the United States and Europe to use the drug "off-label", meaning not for its approved use.

That has attracted illegal traders who may put user health at risk.

Novo last week warned of a surge in counterfeit versions of Wegovy and Ozempic offered online, after Germany's federal drug regulator urged pharmacies and drug distributors to be vigilant following the discovery of wholesale batches of fake Ozempic.

While the pens with labels in German were fake, the packaging was genuine and they originated from wholesalers in Austria and Germany, the EMA said in a statement on Wednesday.

"All affected pens have been recalled and accounted for, and none of the pens have been supplied to UK patients," MHRA said.

(Reporting by Eva Mathews and Khushi Mandowara in Bengaluru; Editing by Shinjini Ganguli, Shilpi Majumdar and Devika Syamnath)