Heraldo de Madrid - Fake Ozempic pens circulating in Europe, watchdogs warn

Ozempic, which involves a once-weekly injection from a pre-filled pen, was originally developed to treat type 2 diabetes.

However since it became clear the drug was effective for weight loss, massive demand driven partly by "off label" use of the drug has led to stock shortages.

Now pre-filled pens falsely labelled as Ozempic have been identified at some wholesalers in the EU and UK, according to the European Medicines Agency (EMA).

On Sunday, France's ANSM medicines authority said that "as a precaution, we call on all players in the supply chain to be vigilant" about the fakes.

The counterfeit pens have labels in German and originated from wholesalers in Austria and Germany, the EMA said in a statement last week.

"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 EMA said.

Police and European Union drug regulators are investigating the issue, it added.

Germany's drug regulator BfArM released a picture of the fake pens, showing that they look quite different to the official version.

The counterfeits were first noticed due to inactive serial numbers.

The active ingredient in Ozempic, semaglutide, has been approved in the EU and UK to be prescribed specifically for weight loss under the brand name Wegovy.

Both products are made by the Danish pharmaceutical group Novo Nordisk, which has seen profits soar due to demand for the drug.

Earlier this month, researchers warned that this class of drugs called GLP-1 agonists -- which also includes liraglutide drugs Rybelsus and Saxenda -- was linked to a heightened risk of certain severe gastrointestinal problems including stomach paralysis.

Although rare, the side effects show how important it is that the drugs are only taken when prescribed by doctors, the researchers emphasised.

W.Hidalgo--HdM