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The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of medicines containing semaglutide, following concerns over links to an increased risk of patients developing a rare eye condition.
A report from the PRAC’s January 2025 meeting, published on 17 January 2025, stated that two recent observational studies suggest an elevated risk of patients developing non-arteritic anterior ischemic optic neuropathy (NAION) — a disorder caused by reduced blood flow to the optic nerve, which can lead to loss of vision in the affected eye. However, “two other recent observational studies do not suggest an increased risk”, it said.
Semaglutide, a glucagon-like peptide-1 receptor agonist, is the active substance in diabetes and weight-loss drugs such as Ozempic (semaglutide; Novo Nordisk), Rybelsus (semaglutide; Novo Nordisk) and Wegovy (semaglutide; Novo Nordisk).
The PRAC said it 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 medical literature (including the results of the observational studies)”.
However, it noted that “patients with type 2 diabetes [mellitus] [T2DM] might already have an inherently higher risk of developing the condition”.
In response to a query from The Pharmaceutical Journal as to whether it would conduct a similar assessment into any NAION risk from semaglutide, a spokesperson for the Medicines and Healthcare products Regulatory Agency (MHRA) said it was “closely monitoring” the PRAC’s review.
“Patient safety is our top priority and no medicine would be approved unless it met our expected standards of safety, quality and effectiveness,” the spokesperson said.
“We continually monitor the safety of medicines during their use, including emerging new evidence. If a safety issue is identified, we always act promptly to inform patients and healthcare professionals and take appropriate steps to mitigate any identified risk.”
“Semaglutide is a prescription-only medicine and should only be obtained following a consultation with a qualified healthcare professional,” they added.
A study published in July 2024 was the first to report a link between semaglutide and NAION.
Researchers analysed six years of data from more than 16,800 neuro-opthalmology patients and found that the risk of NAION occurring for the first time over a 36-month time period was 8.9% among patients with T2DM who had been prescribed semaglutide (n=194), compared with 1.8% in 516 patients with T2DM prescribed other antidiabetic medicines.
Semaglutide has also been linked to reports of suicidal ideation and self-injurious thoughts; however, reviews from both the EMA and MHRA found no causal link between the drug and psychiatric reactions.
