Ozempic is in great demand for its alternative use against obesity and as a weight loss solution, but they are not the only reasons
For over a month in Italy it has been increasingly difficult to find Ozempic, a drug that is used for the treatment of type 2 diabetes mellitus. The active ingredient of the drug is semaglutide and its shortage derives from a generalized increase in demand in many western countries, where it is also used as a remedy against obesity.
The drug has also become very fashionable in recent months following word of mouth on social networks and some statements by famous people, such as the billionaire Elon Musk, who have said have used it successfully for weight loss. On TikTok there are videos of people filming themselves injecting semaglutide, without clear information on how the drug works and above all on the risks it can pose to health.
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Semaglutide is not new in itself: it is now about ten years old and was developed by the Danish pharmaceutical company Novo Nordisk, which sells it under the trade name Ozempic. It was initially approved by health authorities to treat type 2 diabetes mellitus, which involves an increase in the concentration of glucose in the blood (high blood sugar) and a low reaction of the body to insulin, which has the task of keeping under control blood sugar. The disease is initially treated by recommending lifestyle changes, for example by increasing physical activity and modifying the diet, but in many cases it is necessary to take medicines.
Ozempic mimics the behavior of GLP-1 (glucagon-like peptide 1), a hormone that stimulates insulin production and blocks the production of glucagon, which increases blood sugar levels. GLP-1 is produced by our body after a meal and also has the function of making us feel full. Semaglutide and the other drugs of the class to which it belongs exploit the same mechanisms to bring about the feeling of satiety earlier. At the same time, they increase the residence time of food in the stomach, to the point of significantly reducing its intake.
After noticing the effects of Ozempic among diabetics, the prescription of the drug began as an “off-label” remedy against obesity, i.e. to treat health problems other than those for which the principle was originally developed active. This is because Ozempic was initially licensed in many countries solely for use against diabetes.
With the prospect of exploiting new knowledge about its active ingredient, a couple of years ago Novo Nordisk applied for authorization for a new drug called Wegovy which is essentially like Ozempic, but with a higher dosage and expressly made as a remedy against obesity. In 2021 Wegovy was authorized in the United States and in early 2022 also in the European Union.
Both Ozempic and Wegovy are given as an injection under the skin, which should be given once a week (there is also an oral version, under another name, which can be taken every day). Ozempic is available in Italy, while Wegovy is not yet marketed in our country, consequently demand is concentrated almost exclusively on Ozempic, contributing to the shortage reported for several weeks. The drug is distributed in pharmacies only if a prescription is presented and its purchase has been blocked through the presentation of the so-called “white prescription” (the one without reimbursement by the National Health Service) for use among patients suffering from obesity without diabetes.
At the beginning of March, the Italian Medicines Agency (AIFA) had issued an “Important Information Note” on Ozempic, recalling its state of deficiency and the forecast of maintaining this condition until the end of the year, according to forecasts by Novo Nordisk which is currently unable to meet the high demand. In its direct communication to healthcare personnel, AIFA had recalled that: «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. Any other use, including weight management, represents off-label use and currently jeopardizes the availability of Ozempic for the indicated population.”
The increased demand for Ozempic for off-label use has probably influenced the shortage, but it is important to remember that recently there has frequently been less availability of various types of drugs. There were many causes, from those closely linked to high demand during the most acute phases of the pandemic to the raw materials crisis, which affected some production cycles.
Obesity is a clinical condition that should not be underestimated and obese people can benefit from the new treatments, provided that they are prescribed when there are clinical conditions to do so. The Association of Endocrinologists recalled the importance of not “stigmatizing the obese patient” and of avoiding “the efficacy and safety of an already approved drug” being questioned.
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