PRAC MEETING HIGHLIGHTS
PRAC Meeting Minutes are a detailed record of the discussions and decisions made during a meeting of the Pharmacovigilance Risk Assessment Committee (PRAC). PRAC is a committee within the European Medicines Agency (EMA) responsible for assessing and monitoring the safety of human medicines. The meeting minutes typically include:
- Date and Time: JAN 2025.
- Agenda: Topics and issues discussed during the meeting can be found here
- Highlights:Medicines containing semaglutide: PRAC investigating risk of rare eye condition
- PRAC will assess risk of non-arteritic anterior ischemic optic neuropathy (NAION)
- EMA’s safety committee, PRAC, has started a review of medicines containing semaglutide following concerns regarding an increased risk of developing NAION, a rare eye condition, as suggested in two recent observational studies, while two other recent observational studies do not suggest an increased risk.
- Semaglutide, a GLP-1 receptor agonist, is the active substance in certain medicines used in the treatment of diabetes and obesity (namely Ozempic, Rybelsus and Wegovy).
- PRAC is assessing whether patients treated with semaglutide may have an elevated risk of developing NAION. This is a disorder caused by reduced blood flow to the optic nerve in the eye with potential damage to the nerve, which can lead to loss of vision in the affected eye. Patients with type 2 diabetes might already have an inherently higher risk of developing this condition.
- PRAC will now review all available data on NAION with semaglutide including data from clinical trials, post-marketing surveillance, studies on the mechanism of action and the medical literature (including the results of the observational studies). EMA will communicate further when appropriate.
- References:
- Chou CC, Pan SY, Sheen YJ, Lin JF, Lin CH, Lin HJ, Wang IJ, Weng CH. Association between Semaglutide and Non-Arteritic Anterior Ischemic Optic Neuropathy: A Multinational Population-Based Real-World Study. Ophthalmology. 2024 Nov 2: S0161-6420(24)00685-7. doi: 10.1016/j.ophtha.2024.10.030. Epub ahead of print. PMID: 39491755.
- Klonoff DC, Hui G, Gombar S. Real-World Evidence Assessment of the Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide. J Diabetes Sci Technol 2024: 19322968241268050.
- Grauslund, J., Abou Taha, A., Dehghani Molander, L., Kawasaki, R., Möller, S., Højlund, K., & Stokholm, L., Once-weekly semaglutide doubles the five-year risk of nonarteritic anterior ischemic optic neuropathy in a Danish cohort of 424,152 persons with type 2 diabetes, International Journal of Retina and Vitreous, accepted for publication.
- Simonsen E., Lund LC, Thomsen Ernst M., Hjellvik V., Hegedüs L., Hamann S., Kalsnes Jørstad Ø., Løvdal Gulseth H., Karlstad Ø., Pottegård A., 2024 Dec 11 Use of semaglutide and risk of non-arteritic anterior ischemic optic neuropathy: A Danish–Norwegian cohort study medRxiv preprint doi: 10.1101/2024.12.09.24318574 List of participants present at the meeting.
- Links: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 January 2025 | European Medicines Agency (EMA) .
These minutes are essential for ensuring transparency, accountability, and continuity in the pharmacovigilance process. They serve as an official record that can be referred to by stakeholders, including regulatory authorities, pharmaceutical companies, and healthcare professionals.
Role of PRAC
PRAC is responsible for assessing all aspects of risk management of human medicines, including:
- the detection, assessment, minimisation and communication of the risk of adverse reactions, while taking the therapeutic effect of the medicine into account;
- design and evaluation of post-authorisation safety studies;
- pharmacovigilance audit.
References: Pharmacovigilance Risk Assessment Committee (PRAC) | European Medicines Agency (EMA)