EMA’s PRAC Offers Recommendations for Glucagon-like Peptide-1 Receptor Agonists and Glatiramer Acetate

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The European Medicines Agency (EMA) announced on July 12, 2024 that its Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that patients who take glucagon-like peptide-1 receptor agonists (GLP-1 RAs) treatment for type 2 diabetes and obesity consider the risk of aspiration and pneumonia aspiration before going under general anesthesia or deep sedation.

After reviewing data from EudraVigilance case reports, scientific literature, and clinical and non-clinical data, PRAC was unable to find a causal link between GLP-1 analogues and aspiration; however, the committee decided to issue the risk recommendation because GLP-1 RAs create delayed gastric emptying. “[Because of] the presence of clinical trial cases and post marketing cases, the PRAC considered that healthcare professionals and patients should be informed on this potential consequence of delayed gastric emptying,” the committee stated in a press release (1). Product information will be updated to include a warning for patients to inform their doctor if they are using GLP-1 RAs before scheduling surgery or going under deep sedation.

Back in April 2024, PRAC reviewed the potential risk of suicidal tendencies in patients taking GLP-1 RAs but found no link. The review was done after reports were received of users of liraglutide and semaglutide having thoughts of suicide and self-harm. “After reviewing the available evidence from non-clinical studies, clinical trials, post-marketing surveillance data and the available studies, the PRAC considers that no update to the product information is warranted. The marketing authorization holders for these medicines will continue to monitor these events closely, including any new publications, as part of their pharmacovigilance activities and report any new evidence on this issue in their Periodic Safety Update Reports (PSURs),” EMA stated in a press release (2).

PRAC also warned about the possibility of anaphylactic reactions occurring years after treatment initiation of glatiramer acetate, which is used to treat relapsing forms of multiple sclerosis (1). After reviewing data from the European Union, the committee concluded that glatiramer acetate is associated with anaphylactic reactions that can happen immediately or months, or years, after treatment. According to EMA, there have been reports of fatalities. A direct healthcare professional communication to inform healthcare professionals about the risk will be issued. Treatment must be discontinued if a reaction occurs, according to PRAC.

In addition to these two risk recommendations, PRAC announced at its July 2024 meeting that it has selected a new chair, Ulla Wändel Liminga. A pharmacist by training, Liminga is a trained pharmacist from Sweden who is scientific director of Pharmacovigilance at the Swedish Medical Products Agency–MPA. Liminga has expertise in pharmacology, toxicology and pharmacovigilance and has been a PRAC delegate since 2012. PRAC’s previous chair, Sabine Straus, retired as chair after serving for two three-year mandates.

“As a chair, I want to build on the collective experience of PRAC and continue to ensure that our outcomes are proportionate and robust, and that patient safety and public health remain our priority,” Liminga said in a press release (3). “The critical factors to continued success in an ever-evolving internal and external environment will be a continued focus on high-quality scientific assessments and close collaboration withinPRAC, with EMA and its committees, and the EU regulatory network.”

References

1. EMA. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2024. Press Release. July 12, 2024. https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-july-2024#contact-point-68561
2. EMA. EMA Statement on Ongoing Review of GLP-1 Receptor Agonists. Press Release. July 13, 2023.
3. EMA. EMA’s Safety Committee Elects New Chair. Press Release. July 11, 2024. https://www.ema.europa.eu/en/news/emas-safety-committee-elects-new-chair