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Shortage of the anti-diabetic drug: the AIFA alarm

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Shortage of the anti-diabetic drug: the AIFA alarm

Unintended use of anti-diabetic drugs is causing a dangerous shortage. In particular, the Italian Medicines Agency (Aifa), has reported the shortage of Ozempic® (semaglutide) in solution for injection using a pre-filled pen. Behind the shortage there would be an “off-label” use – that is, not foreseen – by those who are not diabetic for the purpose of losing weight. Those who really need it now risk not finding semaglutide anymore. Using antidiabetic drugs for other purposes can also have adverse effects, but their use is depopulating in the so-called “fast diets”, especially among VIPs.

Because there are no antidiabetics

In a note, Aifa communicated the shortage of Ozempic® (semaglutide) solution for injection in a pre-filled pen. The note comes following a communication received from the company Novo Nordisk, which reports that it has experienced a shortage of Ozempic.

“Increased demand for Ozempic® has led to shortages that are expected to continue throughout 2023. While supply continues to increase, it is not possible to predict with certainty when it will be sufficient to fully meet current demand. “.

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. This medicinal product is indicated only for the treatment of adults with inadequately controlled type 2 diabetes mellitus, as an adjunct to diet and exercise. “Any other use, including weight management, represents off-label use and currently jeopardizes the availability of Ozempic for the indicated population.”

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Precisely the unforeseen use of the anti-diabetic drug – used to lose weight – has caused a supply crisis: “A higher than expected demand has caused the shortage of Ozempic®. It is expected that the shortages – reads the Aifa note – ., will continue through 2023. Although the supply continues to increase, it is not possible to estimate with certainty when it will be sufficient to fully meet current demand.The supply shortage is not related to any quality defects of the medicine or safety concerns.

What are the adverse effects

Taking a drug to control diabetes for other unintended purposes, such as weight loss, can be dangerous. The active substance in Ozempic is semaglutide, a molecule similar to the hormone Glp-1, produced by the body to stimulate the release of insulin when blood sugar – ie glucose – levels are high. Semaglutide exploits the same cellular receptors as Glp-1 and produces the same effects on blood sugar. It also slows down the rate at which the stomach empties, reducing cravings.

Among the side effects of the drug is weight loss, which prompted some to use it to lose weight. However, regulatory authorities have not yet approved it for such use, even in patients with a clinical diagnosis of obesity.

The drug is still prescribed, but the therapy should be followed under careful medical supervision. Among the most common effects is nausea, along with vomiting, diarrhea and abdominal pain. But even more serious consequences have been reported: hypoglycemia, fatigue, mental fog, increased heart rate, hair loss, taste disturbance, acute pancreatitis (even at low doses), biliary problems, more rarely severe constipation and intestinal obstruction.

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Following the results on laboratory animals, suspicions have also been raised for an increased risk of thyroid cancer after years of use. Additionally, the adverse effects of semaglutide in healthy people — without type two diabetes or obesity — have not yet been investigated.

Source: Today.it

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