The Medicines Safety Agency warned Wednesday about the misuse of this drug, normally prescribed for diabetes, but used as an appetite suppressant.
An unexpected social media star, whose sudden popularity is causing concern. The antidiabetic Ozempic has known for a few months a growing notoriety on TikTok, where influencers praise the slimming properties of this injectable treatment. The drug will therefore be the subject of a “increased surveillance” in France, announced on Wednesday March 1 the Health Insurance and the Medicines Safety Agency (ANSM) in a joint press release. Franceinfo answers three questions after this decision.
1 What is Ozempic?
Ozempic has been marketed in France by the Novo Nordisk laboratory since 2019. Available only on medical prescription, it is used to treat insufficiently controlled type 2 diabetes. In the form of “solution for injection in pre-filled pens”it can be injected by the patient himself “under the skin of the belly, thigh or upper arm”describes the European Medicines Agency (document in English). Once administered, it increases “the amount of insulin released by the pancreas after food intake”.
The molecule could soon also be prescribed to treat obesity, under the name of Wegovy. In France, Wegovy has received a favorable opinion from the Haute Autorité de santé (PDF document) for this use at the end of December. Pending a decision from the authorities on its price and reimbursement, Wegovy is delivered in dribs and drabs, “unlike Ozempic which is available with a normal prescription”observes Professor Jean-Luc Faillie, head of the regional pharmacovigilance center of the Montpellier University Hospital, in charge of monitoring the pharmacovigilance of this drug.
Besides, “the prescription [du Wegovy] will not be possible with your GP, you will probably have to go see a doctor specializing in obesity, a nutritionist or a doctor who works in a specialized obesity center or a university hospital.specifies the doctor Damien Mascret on France 3.
2 How is its use diverted?
“Reports from the field report misuse in non-diabetic people with the aim of weight loss”, report the ANSM and the Health Insurance. The European Medicines Agency explains that“it appears from the results [d’études] that treatment with Ozempic was associated with a beneficial reduction in body weight”. Thus, according to the data cited by the ANSM, between October 2021 and October 2022, 215,000 patients received Ozempic, but 2,185 of them “can be considered non-diabetic according to the estimates of the Health Insurance”notes the Agency, thus estimating the misuse, over this period of one year, at around 1%.
Faced with this observation, the ANSM and Health Insurance want to strengthen surveillance by monitoring sales and reimbursement data from the national health data system, reports of non-compliant use and reports of adverse effects to regional pharmacovigilance centres. They also remind “that the management of overweight in adults is based above all on diet and physical activity”.
3 What are the risks ?
If diversions are still “boundaries” according to the authorities, however, they are concerned “potentially serious adverse effects”. For Jean-Luc Faillie, the risks of Ozempic are “mastered” in view of the benefits in diabetes, but “there are always uncertainties, especially in obese patients over the long term”. “If we use it to lose a few pounds, there the therapeutic benefit is nil: it’s just aesthetics while the risks are always present”he warns.
Questioned by France 3, Jean-Jacques Altman, professor emeritus of diabetology at the Pompidou hospital (Paris), quotes “pancreatitis” Or “an increased risk of thyroid cancer”. “It’s really taking considerable risks for very small profits”he also repeats.
The ANSM and Health Insurance also discuss the effect of these misuses on the availability of the product for diabetic patients who need it. Supply tensions have been noted by ANSM and Novo Nordisk due to an explosion in demand worldwide. The laboratory explains that its “current supply capacity does not always meet this excess demand” and laments “intermittent availability and periodic stock-outs”.
The vice-president of the French Federation of Diabetics, Jean-François Thébault, testified to France 3: “If I no longer have this medicine, not only will my diabetes be unbalanced, but I will also increase the risk of having a heart attack or a stroke.” According to studies, Ozempic has indeed “shown to be effective in reducing the occurrence of serious diabetes-related health complications, such as heart attacks and strokes”notes the European Medicines Agency.