The new GLP-1 analogues and dual GIP/GLP-1 antagonists represent a step forward in the treatment of chronic conditions such as type 2 diabetes and obesity, whose incidence is on the rise. However, these are prescription-only medicines and should never be considered an easy, risk-free solution for weight loss. They must be used in a responsible way, in accordance with the approved indications and under appropriate supervision by the prescribing doctor.

AIFA produced the guide “New medicines for diabetes and obesity: what you need to know for informed use” (also available as a public information leaflet), which provides an up-to-date and comprehensive overview of safety profile, authorised therapeutic indications, consumption trends and correct clinical use of these medicines. Particular attention is paid to the risks associated with misuse, self-administration without medical supervision and illegal purchase through unauthorised channels.

“With this initiative,” says AIFA President Robert Nisticò, “the Agency aims to strengthen accurate information for citizens and healthcare professionals, support pharmacovigilance and contribute to the protection of public health, promoting responsible access to innovative therapies of growing clinical importance. Medicines are a valuable tool, but they should never be seen as risk-free shortcuts to a healthy lifestyle. The AIFA guide is also an opportunity to emphasise once again that health depends, above all, on prevention and informed behaviour.”

“The document,” says Pierluigi Russo, Technical and Scientific Director, “has been written in response to the growing use of GLP-1 analogues and dual GIP/GLP-1 agonists in the treatment of type 2 diabetes and obesity, and to tackle the need to promote their appropriate, safe and evidence-based use.”

The AIFA guide and the leaflet are available on the Agency’s official website.

The landscape of new treatments

GLP-1 analogues (liraglutide, dulaglutide and semaglutide), GLP-1 receptor agonists (exenatide) and GIP/GLP-1 receptor agonists (tirzepatide) are molecules that mimic the action of natural hormones produced by the gut: they increase insulin production by the pancreas in response to food, slow gastric emptying and act on the central nervous system to reduce feelings of hunger. In this way, they help patients not only to control their blood sugar levels, but also to eat less, promoting significant weight loss.

All these medicines require a prescription, but they are used to treat different conditions:

• For the treatment of type 2 diabetes: medicines such as Ozempic and Rybelsus (semaglutide), Mounjaro (tirzepatide), Victoza (liraglutide), Trulicity (dulaglutide) and Byetta/Bydureon (exenatide) are reimbursed by the National Health Service (Class A/PHT), in accordance with AIFA Note 100. They may be prescribed by GPs and specialists.
• For weight management (obesity and overweight with comorbidities): medicines such as Wegovy (semaglutide), Saxenda (liraglutide) and Mounjaro (tirzepatide, prescribed for this specific indication) are not reimbursed by the NHS and are classified as Class C, with costs borne by the patient.

The boom in consumption

Consumption data show a very marked increase in these medicines over recent years (2020–2024), both in the NHS-reimbursed sector and in the private market. The overall trend also highlights a gradual shift towards the medicines that have seen the fastest growth. For semaglutide alone, the number of packs reimbursed by the NHS rose from around 322,000 in 2020 to over 4 million in 2024 (+48.9% in one year). A very significant increase was also recorded in private purchases paid by the patient, with semaglutide packs rising from around 29,700 in 2020 to over 326,000 in 2024 (+78.4% compared to 2023), whilst tirzepatide, in its first year on the market, exceeded 30,000 packs.

Furthermore, in 2024, within the context of private purchases there was a particularly marked increase (+142.8%) in medicines authorised for weight management compared to those without such an indication, which may reflect a use more in line with authorised indications.

Beware of misuse for weight loss and without medical supervision

The Agency reminds the public that the use of these medicines for weight loss should not be regarded as a ‘shortcut’ to achieving weight loss goals. The medicine must always be part of a comprehensive strategy that includes, amongst other things, a low-calorie diet and physical activity. Its use must always be supervised by the prescribing doctor who will be able to assess the patient’s clinical response, taking into account their overall health, any underlying conditions, their age and the medicines they are taking. Recent studies also show that discontinuing treatment without a radical and sustained change in lifestyle leads to a rapid regain of lost weight (the so-called ‘rebound’ or ‘yo-yo’ effect).

Safety profile and interactions not to be underestimated

Like all medicines, these too have a safety profile that requires monitoring. The most common side effects affect the gastrointestinal tract (nausea, vomiting, abdominal pain, diarrhoea and constipation), particularly in the early stages of treatment and during dose escalation; headaches, dizziness and fatigue are also common. Less frequent but clinically significant events include acute pancreatitis, which requires discontinuation of treatment, and an increased risk of gallbladder disorders, including gallstones. For some drugs in this class, particularly semaglutide, epidemiological studies suggest a possible increased risk of non-arteritic anterior ischaemic optic neuropathy (NAION), which can cause vision loss and requires discontinuation of treatment if diagnosed. Furthermore, the Agency draws attention to drug interactions: concomitant use with insulin or other antidiabetics increases the risk of hypoglycaemia. These medicines are also not recommended during pregnancy.

Avoid self-medication and illegal online purchases

Finally, the Agency reminds the public that self-medication and the use of these medicines outside their authorised therapeutic indications (‘off-label use’), without medical supervision, for purely cosmetic purposes, poses health risks and may lead to shortages of life-saving medicines for diabetic patients. Furthermore, as these are prescription-only medicines, they cannot be purchased online. Counterfeit versions of pre-filled pens (e.g. counterfeit Ozempic) have already been found in Europe, sold on social media, and are extremely dangerous to health. These products have not followed the legal Italian supply chain, which operates under well-established monitoring and control systems. For this reason, purchasing medicines through legal channels is essential and being wary of offers that may come from the internet is equally important.

Published on: 18 May 2026