The French drug safety agency on Wednesday announced it was stepping up monitoring of Ozempic, a diabetes drug promoted by influencers on social networks who flaunt its weight-loss properties. As well as health concerns, the authorities say the increased demand could jeopardise access for legitimate diabetic patients.
In a joint press release with the national health insurance agency, the ANSM said "reports from the field show misuse in non-diabetic people with the aim of weight loss".
The injectable Ozempic has been marketed in France by the Danish Novo Nordisk laboratory since 2019, on medical prescription only, to treat type 2 diabetes.
The government bodies said they will strengthen surveillance by monitoring sales and reimbursement data, as well as reports of non-compliant use and reports of adverse effects.
The ANSM found that between October 2021 and October 2022, approximately 600,000 patients received a drug from the class of GLP-1 analogues, including 215,000 patients who use the Ozempic variety.
A total of 2,185 of these beneficiaries were considered as non-diabetics according to the health insurance agency, representing misuse of the product at around one percent.
Falsified prescriptions
The drug's active ingredient, semaglutide, binds itself to the receptors of a hormone which controls blood sugar, stimulating the release of insulin when glucose levels are high.
It slows down how quickly food leaves a person's stomach, reducing their appetite.
In early 2021, peer-reviewed research found that almost three quarters of people who used the drug lost more than 10 percent of their body weight.
Novo Nordisk has since developed a semaglutide drug with a higher dosage called Wegovy specifically to treat obesity, which was approved for use in the United States in 2021, and in Europe and the UK last year.
Wegovy is not yet on the market in the UK, France or several other countries, but Ozempic is available with a normal prescription.
This has led to a rise in people without diabetes obtaining prescriptions for Ozempic, as well as "falsified prescriptions," said Jean-Luc Faillie, a pharmacology specialist at France's Montpellier University.
A 'miracle'
Doctors have expressed concern that people with diabetes may not be able to get hold of semaglutide because of the soaring demand from people seeking to lose weight.
Novo Nordisk admitted to French news agency AFP that its "current supply capacity does not always meet this excess demand" and lamented "intermittent availability and periodically out of stock".
The company's global manufacturing facilities "are now operating 24 hours, seven days a week" to bridge the gap, it added.
Videos under the hashtag #Ozempic have nearly 600 million views on TikTok, where many users regularly update followers about their weight loss.
"Losing 40 kilograms (88 pounds) in less than three months is possible" thanks to Ozempic, a French TikToker said in a typical post in December with nearly 50,000 views.
"It's a miracle," he added.
Side effects, uncertainties
Doctors have also expressed concerns about the side effects of semaglutide, which Faillie said have gone under-discussed.
"Neither patients nor prescribers are motivated to report" the side effects, he said.
Nausea is the most common side effect of the drug.
But Faillie said "there are also rarer and more serious risks such as acute pancreatitis -- which can occur even at lower doses -- biliary disorders, and rare cases of severe constipation which can lead to bowel obstruction."
He also pointed to an "increased risk of thyroid cancer" following several years of treatment.
While the risks were reasonable considering the benefits for people with diabetes, "there are still uncertainties, particularly in obese patients over the long term," he said.
"If it is used to lose a few kilograms, then the therapeutic benefit is zero," Faillie added.
"That would just be cosmetic, while the risks remain."
(with AFP)
