The diversion of Ozempic, initially an antidiabetic, to lose weight has caused a stock shortage. In Belgium, the measure to reserve it for patients with type 2 diabetes and severe obesity is extended. Behind this popularity are hidden side effects, sometimes unsuspected.
A miracle shot to lose weight? Several drugs, developed to treat diabetes, are now used for the purpose of weight loss. Indeed, the active ingredient they contain imitates the action of an intestinal hormone (GLP-1) which acts on the blood sugar level and reduces appetite.
Global demand for this type of product is growing and continuing. In Belgium, the availability of Ozempic, a flagship drug, is therefore still limited and should remain so. at least until February 2025. The measures taken since last fall to reserve the injection for patients suffering from type 2 diabetes and severe obesity have therefore been extended and will be re-evaluated in November.
Semaglutide and liraglutide
There are two main categories. The liraglutide, found in Saxenda, is a once-daily injection at a high dose and one of the first to be authorized for obesity. The second is semaglutide, with weekly injections. This is the case of Ozempic, diverted in Belgium from its anti-diabetic objective, or of Wegovy, which is not yet on the Belgian market. With a notable difference in price : around 100 euros per month for the Ozempic, up to 1000 dollars per month for the Wegovy.
Who says medication says side effects. The most common are mild to moderately severe gastrointestinal symptoms. “Mainly digestive disorders, especially nausea, and more rarely diarrhea and vomiting,” confirms Agnès Burniat, endocrinologist at Erasme hospital. This is also one of the causes of shutdown (approximately 5%) of the treatment. More serious effects are rare, with some affecting the gallbladder, pancreas and liver.
A gradual intake
In the United States, complaints have been launched against the manufacturer of Ozempic, Novo Nordisk. Among the harmful effects pointed out is gastroparesis, the fact that the stomach empties more slowly. No wonder, according to Agnès Burniat: “This is one of the mechanisms involved in weight loss. There’s has a slowdown in gastric emptying which is linked to the effect of the medication.” Especially since the treatment is taken gradually: “Patients will never take the maximum dose directly. First small ones, to check that they do not vomit and that they tolerate them. Then we work par gradation, if all goes well. Digestive problems often occur at the beginning, and then subside. This remains relatively limited.»
According to Novo Nordisk, these effects are well known and documented in the package insert. But for an American plaintiff, Ozempic, as well as its competitor Mounjaro (from the Eli Lylli firm), caused severe vomiting and pain which took her to the hospital. Other lawsuits have been filed against both companies, accused of downplaying or omitting effects such as stomach paralysis or intestinal obstruction. Companies, as well as health authorities, are also sounding the alarm about “fake” injector pens. These non-approved versionswhich circulate on the internet, can cause much more serious effects.
Not for everyone
Researchers from the University of British Columbia (Canada) confirm the increased risk of gastrointestinal problems. According to the study, patients had nine times more risk of developing pancreatitis, and more than four times the risk of suffering from intestinal obstruction. For gastroparesis, the risk was more than three times higher.
Results that demonstrate the need to prescribe these drugs to those who derive real benefit from itwith obesity or excess weight with comorbidities (hypertension, diabetes, etc.). And not to those who just want to lose a few pounds. “We have deviated towards a prescription for anyone, including those with small excess weight. The easy side attracts : we prick ourselves, and we no longer have to make any effort. The effect is also cerebral: people have less desire to eat and are less attracted to high-calorie foods. And so there is less frustration.” The studies were further combined with diet and regular sports activity.
Suicidal thoughts, an unresolved question
Some potential effects raise questions. After several reports, the European Medicines Agency (EMA) is investigating a possible link between taking Ozempic and the development of suicidal thoughts and self-harm. “We know that there is an effect at the cerebral level, that this can act on the reward system,” explains the endocrinologist. “It’s necessary to be vigilant. Especially since other drugs used for weight loss have been withdrawn from the market due to psychiatric problems.
It is difficult to establish a formal link between the two, when around 10% of the population experiences temporary suicidal thoughts. “You must follow the instructions and provide medical monitoring.»
“Ozempic face”, not a new phenomenon
The aesthetic aspect can also be surprising. On TikTok, people point out the “Ozempic face”, the “Ozempic face”, with hollowed-out faces to support it. The same goes for the buttocks (“Ozempic butt”) and the breasts (“Ozempic boobs”). If the phenomenon has gone viral, it is neither new nor specific to a drug, but simply the cause of rapid weight loss. Because although the skin has elastic properties, it needs time to regain shape.
The endocrinologist confirms, but specifies that in general, losing ten kilos in one month on Ozempic, “ it’s not the majority “. The Wegovy and the Mounjaro cause more loss. If these treatments revolutionize the management of obesity, we must remain vigilant about their long-term effects and the cost of potentially “lifelong” treatment.
Beneficial effects
Semaglutide also seems to have a beneficial effect, although limited, on the risks of heart attack and stroke. Wegovy, approved for weight loss in the United States, is also authorized there to reduce heart risks in obese people with cardiovascular diseases. “These molecules are really interesting,” reacts Agnès Burniat. It also reduces fatty liver and fatty liver. It’s not just weight loss and improved blood sugar levels. »
Parallel market: big risks for the patient
To deal with the shortage of Ozempic, new rules limiting the prescription of the drug were introduced at the end of 2023 in a royal decree. Doctors were required to reserve GLP-1 analogues to type 2 diabetic patients and patients with severe obesityor whose BMI is greater than or equal to 35 or 30 but accompanied by weight-related comorbidities. A measure which was extended in June 2024, the availability of the drug in Belgium still being limited.
Targeted: Ozempic, of course, but also Rybelsus, Victoza, Trulicity and Bydureon. Patients suffering from obesity but who have never been treated with GLP-1 analogues can only have the medication dispensed by an endocrinologist, at least for the first prescription.
A measure that the Belgian Association of Medical Unions (ABSyM) very quickly described as contrary to therapeutic freedom. Whether or not they agree with these new directives, general practitioners, like endocrinologists, are required to comply with them.
But who ensures that this is indeed the case? Checks are carried out by the Federal Agency for Medicines and Health Products (Famhp) among doctors, in collaboration with the FPS Public Health. What is dispensed in pharmacies is subject to a inventory based on an annual scheduleunless a complaint has been filed or specific action is taken. “But the FAMHP is not competent to check in pharmacies whether the patient is eligible to receive Ozempic,” the body specifies to the Vif. To date, the Famhp has not been informed of any irregularities in the delivery of the very popular drug. On the other hand, she was contacted by patients who were to be treated with Ozempic and who were unable to obtain it.
For the moment, no thought has been given to the possibility of prescribing Ozempic to a wider public if the shortage were to end. “However,” specifies the Famhp, “indications may be formally added to the marketing authorization and the package leaflet, after approval by the competent authorities concerned. Until then, in the event of prescription outside the authorized indications, the doctor remains responsible for this off-label use».
In addition to the supply concerns which complicate the lives of diabetics, another problem worries health professionals: the sale of fake injections. People who want to lose a few centimeters but who do not meet the medical criteria, and who have encountered a legitimate refusal from their doctor, try to obtain the drug through indirect channels. However, these counterfeits, in addition to not guaranteeing any effectiveness, can be dangerous for health. According to Novo Nordisk, the company that produces Ozempic, a Belgian woman fell into a diabetic coma after injecting herself with a dose containing five times more insulin than the recommended dose. Already in October 2023, several people were hospitalized in Austria for the same reasons.
The Federal Agency for Medicines and Health Products regularly gets its hands on postal packages containing illegally imported injections, some of which are in reality fake medicines. “Ordering falsified medicines over the internet, through channels other than authorized pharmacies in Europe, puts the patient’s health at risk. There is no no guarantee that the product is manufactured in a manner compliante, neither as to its composition, nor as to its dosage,” warns the Famhp. The Agency has a specific service, a special investigation unit which, in collaboration with customs, the police, the FPS Economy and the authorities of other countries, fights against illicit pharmaceutical practices.
Ludivine Ponciau
