((Automated translation by Reuters, please see disclaimer https://bit.ly/rtrsauto))
(Recast with emphasis on Ozempic counterfeiting, new throughout with details of damage reports obtained by Reuters) by Patrick Wingrove and Maggie Fick
The CEO of Novo Nordisk
NOVOb.CO said Friday the company is working with authorities in several countries to combat counterfeit versions of its popular diabetes drug Ozempic, as new reports emerge of harm to patients around the world entire.
“This is something we take very seriously,” Lars Fruergaard Jorgensen, chief executive of the Danish drugmaker, told Reuters.
The company has tested the suspect products and is working with authorities in countries where counterfeits have been discovered to help them with legal matters, he added. “We cannot act alone
Growing demand for Novo’s weight-loss drug, known chemically as semaglutide, is far outpacing supply, leading to growing concerns about unregulated and counterfeit drugs on the site. .
Counterfeits of Ozempic have been discovered in as many as 16 countries to date, according to the Partnership for Safe Medicines, an anti-counterfeiting group.
Reports obtained last week by Reuters through the Freedom of Information Act (FOIA) show that patients suffered harm after taking fake Ozempic in Belgium, Iraq, in Serbia and Switzerland last year.
Although Ozempic is approved for diabetes, it contains the same active ingredient as Wegovy, Novo’s powerful weight loss drug, and has been used off-label for weight loss.
The World Health Organization said global shortages of these drugs were linked to a rise in suspected counterfeits. Last week, Robert Califf, director of the US FDA, said there were likely more cases of online sales of fake obesity drugs than had been reported.
The reports, submitted by Novo to the U.S. Food and Drug Administration, show that people suffered dangerous drops in blood sugar levels, called hypoglycemia, after taking suspected or confirmed counterfeit versions of the drug. . This information adds to previous confirmed reports of such cases in countries including Austria, Britain, Lebanon and the United States ().
INSULIN SOLD UNDER THE NAME OF OZEMPIC
A report filed with the FDA regarding a 45-year-old woman in Belgium says she suffered a seizure and ended up in a diabetic coma after taking Ozempic suspected to be a fake drug for losing weight. Her doctor said she injected at least 18 doses of pure insulin, nearly five times the recommended dose for a person with diabetes, according to the report.
The incident is listed in the FDA’s public database of adverse event reports, 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 that it was likely an Apidra Solostar insulin pen from French manufacturer Sanofi SASY. PA which had been relabeled.
The drugmaker separately told Reuters it found a Semglee insulin pen in the United States last June, made by Indian drugmaker Biocon BION.NS , on which a suspected Ozempic label had been stuck. to be a counterfeit.
Mr. Jorgensen said he had also heard of cases where insulin pens had been relabeled and repackaged under the Wegovy name, noting that it is easier to print a box than to develop a fake injector pen.
COMPOSITION
Jorgensen, echoing Califf’s comments from the FDA, also said that semaglutide compounded in the United States poses a serious health concern and that the raw materials, or active pharmaceutical ingredients (API), for these products came from facilities not regulated in Asia and elsewhere.
“We don’t know them and we really have no idea or ability to understand what the API is in a certain compounded product,” he said.
While fake medications often do not contain any of the medications advertised, compounded medications are custom-made medications using the same ingredients as brand-name medications. Because Wegovy and Ozempic are rare, they can be produced legally by licensed pharmacies in the United States.
Other reports obtained by Reuters through freedom of information requests show that a person died last year from abnormal blood clotting after taking a drug advertised as the compound semaglutide. Three other people suffered severe vomiting and nausea, sensory loss in their legs and a drop in blood platelet levels.
The doctor whose patient died stated that the event was possibly related to the use of compounded semaglutide.
The Alliance for Pharmacy Compounding, which represents compounding pharmacists and technicians, did not respond to a request for comment but said drugs that are not made in state-licensed pharmacies () are not masterful preparations.