EMA and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued recommendations to tackle shortages of the glucagon-like peptide-1 (GLP-1) receptor agonists Ozempic (semaglutide), Saxenda (liraglutide), Trulicity (dulaglutide) and Victoza (liraglutide). GLP-1 receptor agonists are authorised for the treatment of diabetes1 or for weight management under certain conditions2 or both3.

Since 2022, a surge in demand for some of these medicines, coupled with other issues such as manufacturing capacity constraints, has led to shortages across the EU.

The use of GLP-1 receptor agonists for cosmetic weight loss in people without obesity or people with overweight who do not have weight-related health problems has been mentioned frequently in news outlets and social media and is worsening existing shortages. The continued high demand for these medicines has also attracted criminal activity, increasing the risk of falsified products entering the market with serious consequences for public health4.

EMA and the EU regulatory network have been closely monitoring the situation and taking actions since 2022 (see “More about the management of these shortages”). The recommendations by the MSSG mark the next phase in the coordinated response to the ongoing shortages.

“We need to step up actions now - industry, regulators, healthcare professionals, patients and the public at large all have a role to play in resolving these shortages and we are appealing to everyone to play their part.”

Emer Cooke, EMA’s Executive Director

Member States should consider, jointly with marketing authorisation holders, measures to control and optimise the distribution of these medicines. Member States’ continuous collaboration and cooperation through the Medicine Shortages Single Point of Contact Working Party (SPOC WP) will allow the MSSG to gain a comprehensive overview of the situation and assess the impact of the measures taken. Member States are also encouraged (together with experts and learned societies) to develop guidelines to facilitate prioritisation of patients who have the greatest need for the medicines.

To gain a comprehensive overview of how these medicines are used in real life, the MSSG has agreed to carry out a study based on real world data (via DARWIN EU5). The MSSG also recommended marketing authorisation holders to increase manufacturing capacity and to continue engaging with regulatory authorities to ensure coordination. In addition, and in accordance with national law, marketing authorisation holders of GLP-1 receptor agonists will need to ensure that the messages they use to promote these medicines have been approved by regulatory authorities. Claims made by companies in the context of such activities should align with rational medicine use and public health goals. Marketing authorisation holders should also consider implementing awareness campaigns on weight management and educational activities on the ongoing shortage and its implications for clinical practice.

In order to gain a comprehensive overview of the situation, discuss and identify possible additional solutions, the MSSG is organising a multistakeholder workshop on 1 July 2024. This workshop will bring together all key actors, including international regulators, to discuss additional measures to improve the supply of GLP-1 receptor agonist medicines in the EU / EEA.

“Bringing everyone to the table is the most effective way to solve these complex shortages.”

Professor Karl Broich, President of the Federal Institute for Drugs and Medical Devices (BfArM) and chair of the HMA

The MSSG is also appealing to healthcare professionals and members of the public to follow some key recommendations.

Information for healthcare professionals

  • The GLP-1 receptor agonists Bydureon, Byetta, Lyxumia, Ozempic, Rybelsus, Trulicity and Victoza are indicated for diabetes only, Saxenda and Wegovy are indicated for weight management as an adjunct to diet and exercise in people who have obesity or overweight with weight-related health issues. Mounjaro is authorised for both diabetes and weight management under certain conditions. Any other use represents off-label use which will worsen existing shortages.
     
  • The MSSG is concerned about excessive off-label use of some GLP-1 receptor agonists, which puts at risk the availability of these medicines for their approved uses with potential serious consequences for patients. The MSSG therefore recommends that healthcare professionals prescribe these medicines in line with their authorised use(s) only, taking into account guidance issued by national authorities or applicable national therapeutic guidelines.
     
  • GLP-1 receptor agonists are not approved for, and should not be used for, cosmetic weight loss, i.e. use for weight loss in people without obesity or people with overweight who do not have weight-related health problems. Healthcare professionals should consider offering these people lifestyle advice instead.

Information for members of the public

  • The medicines Bydureon, Byetta, Lyxumia, Ozempic, Rybelsus, Trulicity and Victoza are authorised for diabetes only. Saxenda and Wegovy are authorised for weight management and Mounjaro is authorised for both diabetes and weight management. All these medicines (called GLP-1 receptor agonists) are prescription medicines and should only be used under medical supervision. Using these medicines without medical supervision can put your health at risk.
     
  • Diabetes and obesity are chronic (long-term) diseases and therefore GLP-1 receptor agonists are intended for long-term treatment. However, like all medicines, they can cause side effects. The most common side effects with GLP-1 receptor agonists (which may affect more than 1 in 10 people) include problems with the digestive system, such as diarrhoea and nausea (feeling sick).
     
  • Due to the high demand for these medicines, there is a risk of substandard or falsified medicines being offered online. Using falsified medicines can have serious health consequences. To avoid this risk, you should not purchase GLP-1 receptor agonists without a medical prescription. When buying these medicines online you should only order from pharmacies that are registered with the national competent authorities in the EU Member States. More information on buying medicines online in the EU and how to recognise registered pharmacies can be found here: Buying medicines online.
     
  • If you are already being treated with a GLP-1 receptor agonist and your medicine is not available, you should discuss this with your doctor, who may switch you to another treatment.

More about the management of these shortages

For the past 2 years, EMA and the EU regulatory network have been closely monitoring these shortages through the Medicine Shortages SPOC WP and the MSSG. The redistribution of stocks among EU Member States has been facilitated to avoid stocks running out and patients not getting the medicines they need. EMA and the European medicines regulatory network hold regular meetings with the marketing authorisation holders (MAHs) to gain a full oversight of the market situation, including current and anticipated shortages, and closely monitor the effects of any mitigation actions. EMA also exchanges information with its international counterparts to foster a more global understanding of the situation.

Some EU Member States have also implemented tailored measures to control the supply of these medicines within their national healthcare systems.

More about the MSSG

Under its new mandate (Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123), EMA has new responsibilities to monitor critical medicines shortages that might lead to a crisis situation. The MSSG was set up to ensure a robust response to medicine supply issues caused by major events or public health emergencies. The members of the MSSG include representatives of EU Member States, one representative of the European Commission, one EMA representative, as well as an observer from EMA’s Patients’ and Consumers’ Working Party (PCWP) and an observer from EMA’s Healthcare Professionals’ Working Party (HCPWP).

For more information about EMA’s responsibilities in monitoring and mitigating medicine and medical device shortages under Regulation (EU) 2022/123, see Crisis preparedness and management.

More about the medicines

GLP-1 receptor agonists1,2,3,4,5 act in the same way as GLP-1 (a natural hormone in the body), by increasing the amount of insulin that the pancreas releases in response to food. This helps with the control of blood glucose levels. They also appear to regulate appetite by increasing a person’s feelings of fullness, while reducing their food intake, hunger and cravings.

Notes 

1 Byetta and Bydureon (exenatide), Lyxumia (lixisenatide), Ozempic, Rybelsus (semaglutide), Trulicity (dulaglutide), Victoza (liraglutide).

2 Saxenda (liraglutide), Wegovy (semaglutide). They are indicated together with diet and physical activity in adults who have obesity (BMI of 30 kg/m2 or more) or overweight (BMI between 27 and 30 kg/m2) and have weight related health problems such as diabetes, abnormally high levels of fat in the blood, high blood pressure or obstructive sleep apnoea (frequent interruption of breathing during sleep). In addition, they can be used in adolescents from 12 years of age with obesity (BMI of 30 kg/m2 or more) who weigh more than 60 kg.

3 Mounjaro (tirzepatide); authorised for type 2 diabetes that is not satisfactorily controlled. It can also used together with diet and physical activity to help people to lose weight and keep their weight under control. It is used in people who have obesity (BMI of 30 kg/m2 or more) or who are overweight (BMI between 27 and 30 kg/m2) and have weight-related health problems.

4  EMA alerts EU patients and healthcare professionals to reports of falsified Ozempic pens (18/10/2023)

5  Data Analysis and Real World Interrogation Network (DARWIN EU)

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