GLP-1 receptor agonists - connecting the dots for you

It’s easy to get lost in the web of recent news and social media posts about the medicines known as glucagon-like peptide-1 receptor agonists (GLP-1 RA), such as Ozempic, Wegovy or Mounjaro.

These medicines are authorised for the treatment of diabetes[1] or for weight management under certain conditions [2] or both[3].

As for all medicines, EMA and EU national authorities continuously monitor the benefits and risks of GLP-1 RAs, but the sudden rise in demand of these medicines has presented its own set of challenges for all stakeholders involved.

#shortages 

Increased overall demand for GLP-1 RA coupled with capacity constraints at some manufacturing sites have led to shortages, including out-of-stock situations across the EU. The shortage started in 2022 and will continue throughout 2024 for some of the GLP-1 RA

The GLP-1 RAs are authorised for certain indications and any other use represents off-label use and currently places the availability of the medicines for the indicated population at high risk.

Shortages of these medicines prevent patients from getting the treatment they need. In addition people may be at risk of being exposed to counterfeit or falsified medicines which are proliferating due to high demand for these medicines. EMA is therefore working on a campaign to warn the public of the dangers of buying medicines from unlicensed online pharmacies, willing to sell medicines without a prescription. Further information on staying safe when buying medicines online can be found on EMA’s webpage.

EMA and the European network are committed to tackling the shortages and a number of actions were implemented so far. Amongst others, discussions about GLP-1 RA supply and availability take place at the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), which has a central coordinating role in preventing and mitigating medicines shortages in the EU.

As part of the MSSG activities, currently, a multistakeholder workshop is being organised to provide a forum for all concerned stakeholders to discuss the current situation and find further solutions. Dedicated discussions with other countries outside of the EU/EEA are taking place within the Drug Shortages Global Regulatory Working Group to foster exchange and a global understanding.

#safety

Information on these medicines on social media is often limited to personal experiences with little or no mention of the need for a prescription and medical supervision, and the potential for side effects. This is concerning considering the current trend of people turning to social media for health advice.

It is therefore important to remember that, like all medicines, GLP-1 receptors agonists have side effects, the most common ones being problems with the digestive system, such as diarrhoea and nausea (feeling sick).

EMA and national authorities continuously monitor the safety of these medicines. 

This continuous monitoring has recently resulted in three reviews by EMA’s safety committee (PRAC), looking at suicidal thoughts and thoughts of self-injury, thyroid cancer and intestinal obstruction. The PRAC found that the available evidence so far does not show that these medicines cause people to self-harm or to have suicidal thoughts or cause thyroid cancer. On the other hand, the Committee concluded that intestinal obstruction may be a possible risk for the medicines Ozempic, Wegovy and Rybelsus and as a result recommended an update to the product information. A review into a potential link between these medicines and aspiration pneumonia (lung infection caused by breathing food or liquid into the airways or lungs) is currently ongoing.

In order to minimise the risk of side effects with these medicines and to ensure that any risks can be managed appropriately it is therefore important that the medicines are always used with a prescription and under medical supervision.  

EMA will continue to closely monitor GLP-1 receptors agonists and review any new evidence that emerges. We will keep you updated as new evidence emerges.