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European drug authorities have issued recommendations to address ongoing shortages in glucagon-like peptide 1 (GLP-1) receptor agonists used to treat type 2 diabetes and obesity. These drugs include Ozempic (semaglutide), Saxenda (liraglutide), Trulicity (dulaglutide), and Victoza (liraglutide).
Since 2022, GLP-1 receptor agonists have gained popularity on social media, where high profile influencers have endorsed them as miracle weight loss drugs. But their off-label use, particularly by individuals who do not have diabetes or obesity, is reducing the drugs’ availability and placing the public at risk for harm.
Now, following the work of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) are re-emphasizing to healthcare professionals that these medicines should only be prescribed for their authorised uses and that it is necessary to strictly adhere to national guidelines.
Karl Broich, HMA chair
“The recommendations are a reminder that any use outside of the indications of the individual medicines is considered off-label and that this use will aggravate existing shortages,” Karl Broich, president of the Federal Institute for Drugs and Medical Devices and chair of the HMA, said at a press briefing.
Broich emphasised that healthcare professionals should not use these medications for cosmetic weight loss in individuals without obesity or weight-related health problems. Instead, they should offer lifestyle advice to those seeking weight loss without underlying health issues.
He said off-label use can put patients’ health at risk because GLP-1 agonists come with side effects, sometimes severe. Doctors should prioritise these medications for patients with genuine medical needs and ensure uninterrupted access during shortages.
Shortages Are Major Public Health Concern
Emer Cooke, EMA executive director
According to the Organisation for Economic Cooperation and Development, one in six Europeans currently lives with obesity. Also, the number of people with diabetes in the European Union (EU) is projected to reach 38 million by 2030. “The demand for these medicines continues to increase, and the current supply cannot keep up,” said Emer Cooke, EMA’s executive director, at the press briefing.
GLP-1 agonist shortages are putting those who need these medications the most at risk.
“Patients who have been prescribed GLP-1 agonists risk a discontinuation of their medication. This can have a major impact on their stress levels, thus increasing cortisol levels and potentially resulting in weight regain, poorer quality of life, and risk to compromise their ongoing treatment,” Euan Woodward, executive director of the European Association for the Study of Obesity, told Medscape Medical News.
The high demand for these medicines has also fuelled an online market for substandard and falsified medicines. Using falsified medicines can have serious health consequences, said Cooke. To avoid this risk, patients should only purchase GLP-1 receptor agonists with a medical prescription or from pharmacies registered with the national competent authorities in the EU Member States.
“There are some rogue actors claiming to supply weight loss medicines, and it’s very important that consumers realise the potential risks of these unauthorised products,” Cooke said.
“Shortages are a major public health concern, and they require urgent and coordinated action across the member states but also across many actors, including industry, medicines regulators, prescribers, healthcare professionals, pharmacists, and of course patients,” she emphasized.
What Is Happening Behind the Scenes
The EMA and HMA recommendations are part of a more comprehensive series of actions that the EMA is taking to tackle GLP-1 agonist shortages.
For example, it is actively engaging with the pharmaceutical industry to monitor the extent of shortages and advise on plans to increase manufacturing capacity. However, expanding production involves complex procedures such as building new manufacturing sites, transferring operations, or adding filling lines, which are particularly challenging for these complex medicines with intricate manufacturing processes.
The EMA also facilitates stock redistribution between member states. It shares best practices, controls the number of prescriptions individual pharmacies can sell, and limits prescriptions and reimbursements.
“Despite these efforts, we are concerned that our messages don’t always reach the healthcare providers and patients whose efforts really will make the most difference in helping us to manage these shortages,” Cooke said.
Broich said health authorities encourage companies to think carefully about promotional activities. “As long as the shortage situation persists, we should avoid promotional activities. Claims made in the context of such activities should align with the rational use of these medicines and with public health goals. Companies should also implement awareness campaigns on weight management and educational activities on the ongoing shortage and its implications for clinical practice.”
The MSSG has agreed to conduct a study using real-world data (via DARWIN EU) to gain a comprehensive overview of how these medicines are used in real life and expects preliminary results to be available by the end of August. “This will give us an idea of the actual use in practice,” said Cooke.
Manuela Callari is a freelance science journalist specialising in health and medicine.
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Copyright for syndicated content belongs to the linked Source : Medscape – https://www.medscape.com/viewarticle/europe-acts-address-glp-1-drug-shortages-2024a1000c8f
