By Patrick Wingrove and Maggie Fick

London: Novo Nordisk‘s CEO on Friday mentioned the corporate was working with authorities in a number of international locations to sort out counterfeit variations of its well-liked diabetes drug Ozempic, as new studies emerge of affected person hurt internationally.

“This is something we take very seriously,” Lars Fruergaard Jorgensen, CEO of the Danish drugmaker, instructed Reuters.

The firm has been testing suspect merchandise and collaborates with authorities within the international locations the place counterfeits are discovered to help in authorized circumstances, he mentioned. “We cannot take action on our own.”

Surging demand for Novo’s medicine that promote weight reduction, identified chemically as semaglutide, far outpaces provide, more and more giving rise to considerations about unregulated and counterfeit medicines.

Counterfeit Ozempic has been present in as many as 16 international locations to this point, based on the Partnership for Safe Medicines, an anti-counterfeiting group.

Reports obtained within the final week by Reuters through Freedom of Information Act (FOIA) requests present sufferers had been harmed after taking faux Ozempic in Belgium, Iraq, Serbia and Switzerland final yr.

While Ozempic is authorized for diabetes, it has the identical energetic ingredient as Novo’s highly effective weight-loss drug Wegovy and has been used off-label for weight reduction.

The World Health Organisation has mentioned world shortages of those medicine is linked to rising studies of suspected counterfeits. Last week, U.S. FDA head Robert Califf mentioned there have been seemingly extra circumstances of on-line gross sales of faux weight problems medicine than reported.

The studies, made by Novo to the U.S. Food and Drug Administration, confirmed that individuals suffered harmful drops in blood sugar, referred to as hypoglycemia, after taking suspected or confirmed faux variations of the drug. They add to earlier confirmed studies of such circumstances in international locations together with Austria, Britain, Lebanon and the U.S.

Insulin

A report filed with the FDA on a forty five year-old lady in Belgium said that she suffered a seizure and ended up in a diabetic coma after taking suspected faux Ozempic to shed weight. Her physician mentioned she had injected a minimum of 18 doses of pure insulin, nearly 5 occasions the advisable dose for somebody with diabetes, the report confirmed.

The incident seems within the FDA’s public adversarial occasions reporting database, however the particulars had been obtained by Reuters.

In a separate report, Novo Nordisk wrote that it investigated a suspected faux injector pen in Iraq and concluded it was presumably an Apidra Solostar insulin pen from French drugmaker Sanofi that had been relabeled.

The drugmaker instructed Reuters individually that it had discovered a Semglee insulin pen within the U.S. final June, made by Indian drugmaker Biocon, that had a suspected counterfeit Ozempic label glued onto it.

Jorgensen mentioned he had additionally heard of circumstances by which insulin pens had been relabeled and repackaged as Wegovy, noting that it is simpler to print a field than develop a faux injector pen.

Compounding

Jorgensen, echoing feedback from the FDA’s Califf, additionally mentioned compounded semaglutide within the United States was a critical well being subject, and that the uncooked supplies, or energetic pharmaceutical components (API), for these merchandise had been coming from unregulated services in Asia and elsewhere.

“We don’t know them, and we have really no insights or ability to understand what the API is in a certain compounded product,” he mentioned.

While faux medicine typically don’t include any of the remedy marketed, compounded medicine are custom-made medicines which are based mostly on the identical components as branded medicine. Because Wegovy and Ozempic are briefly provide, they are often legally produced by licensed pharmacies within the U.S.

Further studies obtained by Reuters by way of FOIA requests present that one individual died final yr from irregular blood clotting after taking a drug that was marketed as compounded semaglutide. Three others suffered extreme vomiting and nausea, sensory loss of their legs, and a drop in blood platelet ranges.

The physician whose affected person died reported that the occasion was presumably linked to make use of of compounded semaglutide.

The Alliance for Pharmacy Compounding, which represents compounding pharmacists and technicians, didn’t reply to a request for remark however has mentioned medicine that aren’t made at state-licensed pharmacies aren’t compounded medicines. (Reporting by Patrick Wingrove, Maggie Fick and Jacob Gronholt-Pedersen; Editing by Caroline Humer and Bill Berkrot)