It has been available in Italy since 2018, authorized only as an effective drug for glycemia control in people with type 2 diabetes (in support of diet and physical activity). But semaglutide, the analogue of the GLP-1 hormone developed by the Danish company Novo Nordisk, over the months has also shown a (positive) effect on the loss of excess kilos. A property that in 2021 led the Food and Drug Administration to give the green light to a particular formulation of semaglutide (with a higher dosage) also for the treatment of obesity.
In our country, the drug cannot yet be sold with this indication. Yet for weeks there has been a shortage that is preventing some diabetic patients from finding semaglutide. It is the effect of the visibility given to this molecule on social networks as a “shortcut” to lose the extra kilos. To advertise it, celebrities such as Elon Musk and several guys on Tik Tok.
The information note of the Italian Medicines Agency
Thus, due to a suddenly growing demand, the Italian Medicines Agency issued a note to inform the population that “the shortcomings of Ozempic (the commercial name of the injectable formulation of semaglutide, ndr) will continue throughout 2023”. This is because, “although supply continues to increase, it is not possible to predict with certainty when it will be sufficient to fully meet current demand”.
Hence the recommendation addressed by via del Tritone to specialists and general practitioners. “Please ensure that patients using Ozempic are informed of the above and, if at risk of drug depletion, are safely transferred to another GLP-1 agonist or other suitable treatment alternatives based on clinical evaluation. ”.
It is not clear at the moment how non-diabetic people are getting the chance to buy this drug: whether through inappropriate prescriptions or through an unofficial market.
Anti-obesity drugs: here are those available in Italy
Semaglutide belongs to the same class of drugs as liraglutide, for which there is also an indication for use (in Italy) as an effective active ingredient in the treatment of obesity. Not only in adults, but for a few months also in adolescents. In Italy, in addition to liraglutide, two other antiobesity drugs are available: orlistat (acts at the level of the gastrointestinal tract, reducing the absorption of fats introduced with the diet) and the combination of naltrexone-buproprion (psychopharmaceuticals that act at the level of the nervous system reducing appetite and facilitating adherence to an appropriate diet).
Semaglutide: what does the science say?
Considering the results of the first clinical trial published in the “New England Journal of Medicine”, semaglutide therapy seems able to determine a weight loss that can reach up to twenty percent. A goal never achieved by other drugs authorized for the treatment of obesity, followed by the improvement of a series of risk indicators for metabolic health: such as blood pressure, abdominal circumference and levels of sugars and fats in the blood.
In addition to stimulating the production of insulin by the pancreas, so as to accelerate the metabolism of carbohydrates after meals, semaglutide would act on the hypothalamic centers of hunger and satiety. With the result of helping people eat less and reduce their calorie intake.
AIFA invites not to use semaglutide as a “slimming”
This is what emerged from clinical studies, with a maximum observation period of two years. Long enough for the FDA to give the green light to a new formulation of semaglutide, with a higher dosage of the active ingredient (Wegovy). In Italy, however, at the moment Ozempic is indicated exclusively “for the treatment of adults with type 2 diabetes mellitus that is not adequately controlled in addition to diet and physical exercise”, is what AIFA recalled. “Any other use, including weight management, represents off-label use and currently jeopardizes the availability of the drug for the indicated population.”