The Italian Medicines Agency (Aifa) turned on the alarm light. There is a shortage of an antidiabetic drug, Ozempic (Semaglutide) in solution for injection using a pre-filled pen. The cause would be attributable to an “off-label” use, i.e. not foreseen, by those who are not diabetic for the purpose of losing weight. AIFA has invited health professionals to inform patients using Ozempic of the risk of running out of the product and to envisage an alternative therapy, to avoid clinical consequences such as hyperglycemia. We explored the subject with the director of the Romagna Endocrinology and Metabolic Diseases Unit of the Morgagni-Pierantoni hospital in Forlì, Maurice Nizzoli.
Doctor Nizzoli, what is Semaglutide?
Semaglutide is a drug analogue of an enterhormone GLP1 (glucagon-like peptide 1); when we take a meal, a GLP-1 enterhormone is secreted by the cells of the intestine which favors the release of insulin, favoring the entry of glucose into the cells where it is metabolized to produce energy; it also inhibits the release of glucagon which has an action contrary to that of insulin. The final effect is the reduction of blood sugar after a meal. the industry has modified this molecule allowing a protracted action over time instead of being inactivated in a few minutes as naturally happens. This drug allows the normalization of blood sugar in diabetic patients without causing hypoglycemia, i.e. an excessive lowering of the concentration of glucose in the blood”.
Other beneficial effects of the drug?
“It acts on areas of the brain that regulate appetite and food intake, it slows down gastric emptying; the final effect is to be less hungry and feel full sooner; all this allows weight loss and the improvement of some risk factors such as hypertension and dyslipidemia, reducing the overall cardiovascular risk, as well as improving the compensation of diabetes by regulating blood sugar values”.
How is it administered?
“It is given subcutaneously once a week, with a dosage of 0.5 to 1 mg milligram in people with diabetes; its use for this disease dates back to 2019; in 2021 it was also approved as an anti-obesity drug at a dose of 2.4 mg/week. In Europe it has had the same indications as an anti-obesity drug, but it is not yet on the market. There is also an oral Semaglutide, which is administered daily, but which is not as effective in blood sugar and weight control.”
What are the side effects?
“Abdominal pain, nausea, vomiting and diarrhea and diarrhea are the most common side effects; in some they appear at the beginning of the therapy and then within a few weeks they fade until they disappear; in others they persist with the need to stop the drug. Rare cases of acute pancreatitis have been described. It is an important drug that must be administered with a doctor’s prescription”.
The increase in demand for Ozempic has led to shortages that are expected to continue throughout 2023.
“The Novo pharmaceutical company that produces it has sent a disclosure which indicates that the 0.5 milligram dose will be available by the end of March, while the 1 milligram dose will be available after May. Therefore it is possible to hypothesize the administration of two doses of 0.5mg on the same day in those who took 1mg. In case of unavailability of the drug, it is possible to proceed with the use of other GLP-1 agonists, even if the effectiveness is not always superimposable and in any case always after consulting your doctor. The shortage of the drug can be attributed to the enormous demand as an anti-obesity drug in the countries where it is marketed for this indication.”
What are the main guidelines to follow?
“This type of drug must be administered exclusively after a medical prescription and for now only in the population affected by type 2 diabetes and aged over 18; it cannot still be prescribed in people with obesity with a Bmi greater than 30 with cardiovascular risk factors where a correct lifestyle and a correct diet have failed; it should not be prescribed for the treatment of simple overweight. Those who want to lose weight must follow a controlled diet and do regular physical activity. In short, it is necessary to change the overall lifestyle to obtain positive results in the medium and long term. There is no magic pill to fight obesity”.