The Italian Medicines Agency (IFA) has turned on the warning light. The antidiabetic drug Ozempic (Semaglutide) is absent in a solution for injection using a ready-to-use pen. The reason can be attributed to its “off-label”, i.e. unexpected, use by non-diabetics for the purpose of weight loss. AIFA urged healthcare professionals to inform patients using Ozempic of the risk of product depletion and to consider alternative treatment to avoid clinical consequences such as hyperglycaemia. We explored the subject with the director of the unit of endocrinology and metabolic diseases in Romania at the Morgagni-Pierantoni hospital in Forli, Maurice Nizoli.
Dr. Nizoli, what is semaglutide?
Semaglutide is a pharmacological analogue of the intestinal hormone GLP1 (glucagon-like peptide 1); When we eat, the intestinal hormone GLP-1 is secreted by the intestinal cells which promotes the secretion of insulin, promoting the entry of glucose into the cells where it is metabolized to produce energy; It also inhibits the release of glucagon, which interferes with the action of insulin. The net effect is to lower blood sugar after eating. The industry has modified this molecule to allow a prolonged action over time, instead of deactivating it in a few minutes, as would happen naturally. This drug allows you to normalize blood sugar levels in patients with diabetes without causing hypoglycemia, that is, an excessive decrease in the concentration of glucose in the blood.
Other beneficial effects of the drug?
“It works on areas of the brain that regulate appetite and food intake, delaying stomach emptying. The net effect is that you feel less hungry and full sooner; all of this leads to weight loss, an improvement in certain risk factors, such as hypertension, blood pressure and dyslipidemia, and a reduction in the risk of heart disease and blood vessels in general, in addition to improving the compensation of diabetes by regulating the values blood sugar.
How is it managed?
“It is administered subcutaneously once a week at a dose of 0.5 to 1 mg in diabetic patients. Its use for this condition dates back to 2019; in 2021, it was also approved as an anti-obesity drug at a dose of 2.4 mg/ In Europe, it had the same indications as an “anti-obesity drug, but it is not yet on the market. There is also oral semaglutide, which is taken daily but is not as effective for blood sugar and weight management.
What are the side effects?
Abdominal pain, nausea, vomiting, diarrhea and diarrhea are the most common side effects. In some, they appear at the start of treatment and then disappear in a few weeks until they disappear; In other cases, they still have to stop the drug. Rare cases of acute pancreatitis have been described. It is an important drug that must be administered by prescription.
Increased demand for Ozempic has created a shortage that is expected to continue through 2023.
Novo Pharmaceuticals, which makes it, sent out a statement saying the 0.5 milligram dose will be available by the end of March, while the 1 mg dose will be available from May. Therefore, it is possible to assume that two doses of 0.5 mg were administered on the same day for those who took 1 mg. If the drug is not available, it is possible to proceed with the use of other GLP-1 agonists, even if the effectiveness cannot always be modified and, in any case, always after consulting your doctor. doctor. The shortage of the drug can be attributed to the huge demand for an anti-obesity drug in countries where it is marketed for this indication.
What are the main guidelines to follow?
“This type of medicine should only be given by prescription and, currently, only for people with type 2 diabetes over the age of 18; cannot yet be prescribed to obese people with a BMI over 30 with other factors. Cardiovascular risk where proper lifestyle and diet fail; It should not be prescribed to treat simple weight gain. Anyone wishing to lose weight should follow a controlled diet and exercise regularly. In short, you have to change your lifestyle to obtain positive results in the medium and long term. There is no magic pill to fight obesity.