March 8 (Reuters) - Novo Nordisk's CEO on

Friday said the company was working with authorities in several

countries to tackle counterfeit versions of its popular diabetes

drug Ozempic, as new reports emerge of patient harm across the

world.

"This is something we take very seriously," Lars Fruergaard

Jorgensen, CEO of the Danish drugmaker, told Reuters.

The company has been testing suspect products and

collaborates with authorities in the countries where

counterfeits are found to assist in legal cases, he said. "We

cannot take action on our own."

Surging demand for Novo's drugs that promote weight loss,

known chemically as semaglutide, far outpaces supply,

increasingly giving rise to concerns about unregulated and

counterfeit medicines.

Counterfeit Ozempic has been found in as many as 16

countries to date, according to the Partnership for Safe

Medicines, an anti-counterfeiting group.

Reports obtained in the last week by Reuters via Freedom

of Information Act (FOIA) requests show patients were harmed

after taking fake Ozempic in Belgium, Iraq, Serbia and

Switzerland last year.

While Ozempic is approved for diabetes, it has the same

active ingredient as Novo's powerful weight-loss drug Wegovy and

has been used off-label for weight loss.

The World Health Organization has said global shortages of

these drugs is linked to rising reports of suspected

counterfeits. Last week, U.S. FDA head Robert Califf said there

were likely more cases of online sales of fake obesity drugs

than reported.

The reports, made by Novo to the U.S. Food and Drug

Administration, showed that people suffered dangerous drops in

blood sugar, called hypoglycemia, after taking suspected or

confirmed fake versions of the drug. They add to previous

confirmed reports of such cases in countries including Austria,

Britain, Lebanon and the U.S.

INSULIN SOLD AS OZEMPIC

A report filed with the FDA on a 45 year-old woman in

Belgium stated that she suffered a seizure and ended up in a

diabetic coma after taking suspected fake Ozempic to lose

weight. Her doctor said she had injected at least 18 doses of

pure insulin, almost five times the recommended dose for someone

with diabetes, the report showed.

The incident appears in the FDA's public adverse events

reporting database, but the details were obtained by Reuters.

In a separate report, Novo Nordisk wrote that it

investigated a suspected fake injector pen in Iraq and concluded

it was possibly an Apidra Solostar insulin pen from French

drugmaker Sanofi that had been relabeled.

The drugmaker told Reuters separately that it had found

a Semglee insulin pen in the U.S. last June, made by Indian

drugmaker Biocon, that had a suspected counterfeit

Ozempic label glued onto it.

Jorgensen said he had also heard of cases in which

insulin pens were relabeled and repackaged as Wegovy, noting

that it's easier to print a box than develop a fake injector

pen.

COMPOUNDING

Jorgensen, echoing comments from the FDA's Califf, also said

compounded semaglutide in the United States was a serious health

issue, and that the raw materials, or active pharmaceutical

ingredients (API), for these products were coming from

unregulated facilities 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 said.

While fake drugs often do not contain any of the medication

advertised, compounded drugs are custom-made medicines that are

based on the same ingredients as branded drugs. Because Wegovy

and Ozempic are in short supply, they can be legally produced by

licensed pharmacies in the U.S.

Further reports obtained by Reuters through FOIA

requests show that one person died last year from abnormal blood

clotting after taking a drug that was advertised as compounded

semaglutide. Three others suffered severe vomiting and nausea,

sensory loss in their legs, and a drop in blood platelet levels.

The doctor whose patient died reported that the event was

possibly linked to use of compounded semaglutide.

The Alliance for Pharmacy Compounding, which represents

compounding pharmacists and technicians, did not respond to a

request for comment but has said drugs that are not made at

state-licensed pharmacies are not compounded medicines.