The use of GLP-1 receptor agonists for cosmetic weight loss in non-obese or overweight people who do not have weight-related health problems has been frequently mentioned in the media and social networks and is worsening the existing shortage
EMA Statement
If the off-label use of these medications by people who do not have a health problem continues, the shortage will worsen.
The European Medicines Agency (EMA) and the heads of Medicines Agencies (HMA)through the Medicines Shortages and Safety Executive Steering Group (MSSG), have issued recommendations to address 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 approved for the treatment of diabetes 1 or for weight control under certain conditions 2 or both 3 .
Since 2022, an increase in demand for some of these medicines, along 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 non-obese or overweight people with no weight-related health problems has been frequently mentioned in the media and on social media and is worsening existing shortages. The continued high demand for these drugs has also attracted criminal activity, increasing the risk of counterfeit products entering the market with serious public health consequences. 4 .
The EMA and the EU regulatory network have been closely monitoring the situation and taking action since 2022 (see “More on managing these shortages”). The MSSG recommendations mark the next phase in the coordinated response to the current shortage.
“We must step up our action now – industry, regulators, healthcare professionals, patients and the general public all have a role to play in solving this shortage and we call on everyone to do their part,” he said. Emer Cooke, executive director of the EMA.
The member states should consider, together with marketing authorization holders, measures to control and optimize the distribution of these medicines. The continued collaboration and cooperation of Member States through the Single Point of Contact on Medicines Shortages Working Group (SPOC WP) will allow the MSSG to obtain a comprehensive overview of the situation and assess the impact of the measures taken. Member States (together with experts and scientific societies) are also encouraged to develop guidelines to facilitate the prioritization of patients who have the greatest need for medicines.
For a complete overview of how these are used medicines In real life, the MSSG agreed to conduct a study based on real-world data (via DARWIN EU 5 ).
The MSSG also recommended to holders of marketing authorizations to increase manufacturing capacity and continue to work with regulatory authorities to ensure coordination.
Furthermore, and in accordance with national legislation, GLP-1 receptor agonist marketing authorization holders They will need to ensure that the messages they use to promote these medications have been approved by regulatory authorities.
Claims made by companies in the context of such activities must be aligned with the rational use of medicines and the objectives of public healthMarketing authorisation holders should also consider implementing weight management awareness campaigns and educational activities on the current shortage and its implications for clinical practice.
To obtain a complete overview of the situation, discuss and identify possible additional solutions, the MSSG is organizing a multi-stakeholder workshop on July 1, 2024. This workshop will bring together all key stakeholders, including international regulators, to discuss further 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 this complex shortage,” stressed Professor Karl Broich, President of the Federal Institute for Medicines and Medical Devices (BfArM) and President of the HMA.
The MSSG also calls on healthcare professionals and the general public to follow some key recommendations.
Information for health professionals.
- GLP-1 receptor agonists Bydureon, Byetta, Lyxumia, Ozempic, Rybelsus, Trulicity and Victoza are indicated only for diabetes, Saxenda and Wegovy are indicated for weight control as a complement to diet and exercise in people who are obese or overweight with weight-. related health problems. Mounjaro It is approved for both diabetes and weight control under certain conditions. Any other use represents unauthorized use that will worsen existing shortages.
- The MSSG is concerned excessive, unauthorized use of some GLP-1 receptor agonists, which jeopardizes the availability of these medications for their approved uses, with potential serious consequences for patients. Therefore, the MSSG recommends that healthcare professionals prescribe these medicines only in accordance with their authorized use(s), taking into account guidance issued by national authorities or applicable national therapeutic guidelines.
- GLP-1 receptor agonists are not approved and should not be used for cosmetic weight loss, that is, to lose weight in people without obesity or overweight people who do not have health problems. related to weight. Health professionals should consider offering these people lifestyle advice.
Information for the public
- The drugs Bydureon, Byetta, Lyxumia, Ozempic, Rybelsus, Trulicity and Victoza are authorized only for diabetes. Saxenda and Wegovy are approved for weight management and Mounjaro is approved for both diabetes and weight management. All of these medications (called GLP-1 receptor agonists) are prescription medications and should only be used under medical supervision. Using these medications without medical supervision can put your health at risk.
- The Diabetes and obesity are chronic (long-term) diseases and, therefore, GLP-1 receptor agonists are intended for long-term treatments. However, like all medications, they can cause side effects. The most common side effects of GLP-1 receptor agonists (which may affect more than 1 in 10 people) include problems with the digestive system, such as diarrhea and nausea (feeling sick).
- Due to the high demand for these medicines, there is a risk that they will be offered in line of substandard or counterfeit medicines . The use of counterfeit medicines can have serious health consequences. To avoid this risk, GLP-1 receptor agonists should not be purchased without a prescription. When purchasing these medicines online, you should only order from pharmacies that are registered with the competent national authorities of the EU Member States. You can find more information about purchasing medicines online in the EU and how to recognize registered pharmacies here: Buying medicines online.
- If you are already being treated with a GLP-1 receptor agonist and your medication is not available, you should discuss this with your doctor, who may switch you to another treatment.
More on managing this shortage
For the past 2 years, the EMA and the EU regulatory network have been closely monitoring this shortage through the WP SPOC on Medicines Shortages and the MSSG. The redistribution of stocks between EU Member States has been made easier to prevent them from running out and patients not receiving the medicines they need.
More about MSSG
Under its new mandate (Regulation on the enhanced role of the EMA (Regulation (EU) 2022/123), the EMA has new responsibilities to monitor shortages of critical medicines that could lead to a crisis situation. The MSSG was created to ensure a robust response to medicines supply problems caused by major events or public health emergencies Members of the MSSG include representatives of the EU Member States, a representative of the European Commission, a representative of the EMA, as well as. one observer from the EMA Patient and Consumer Working Group (PCWP) and one observer from the EMA Healthcare Professionals Working Group (HCPWP).
More about medications
GLP-1 receptor agonists 1,2,3,4,5 They act in the same way as GLP-1 (a natural hormone in the body), by increasing the amount of insulin released by the pancreas in response to food. This helps with the control of blood glucose levels. They also appear to regulate appetite by increasing a person’s feeling of fullness, while reducing food intake, hunger, and cravings.
Grades
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 suffer from obesity (BMI of 30 kg/m2 or more) or overweight (BMI between 27 and 30 kg/m2) and weight-related health problems, such as diabetes, abnormally high levels of fat in the blood, high blood pressure or obstructive sleep apnea (frequent stopping 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); authorized for type 2 diabetes that is not satisfactorily controlled. It can also be used along with diet and physical activity to help people lose weight and keep it under control. It is used in people who are obese (BMI 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 about reports of counterfeit Ozempic pens (10/18/2023)
5 Data Analysis and Real-World Interrogation Network (DARWIN EU)
See original link:
https://www.ema.europa.eu/en/news/eu-actions-tackle-shortages-glp-1-receptor-agonists
EMA Statement