The European Medicines Agency’s (EMA) safety committee, the Pharmacovigilance Risk Assessment Committee (PRAC), has concluded its in-depth investigation into medicines containing semaglutide, following concerns surrounding an increased risk of developing non-arteritic anterior ischemic optic neuropathy (NAION). This eye condition is a rare vision-loss disorder that can potentially cause significant vision loss.
The comprehensive review by the EMA’s PRAC involved an exhaustive assessment of all available data related to NAION in patients treated with semaglutide. This included information from non-clinical studies, clinical trials, post-marketing surveillance, and a deep dive into the medical literature. The results from the PRAC’s review have led to the conclusion that NAION is a very rare side effect of semaglutide, affecting up to 1 in 10,000 individuals who are prescribed the medication.
Novo Nordisk A/S’s semaglutide, a GLP-1 receptor agonist, is the active ingredient in several medicines used for treating diabetes and obesity, such as Ozempic, Rybelsus, and Wegovy. These medicines have been under scrutiny in the medical community and among regulatory bodies due to the potential increased risk of NAION.
Furthermore, results from several large epidemiological studies suggest that exposure to semaglutide in adults with type 2 diabetes is associated with an approximately two-fold increase in the risk of developing NAION compared with individuals not taking the medicine.
The identification of this serious side effect emphasizes the critical importance of continuous monitoring and assessment of the safety profile of semaglutide. Healthcare professionals and patients should be cognizant of this potential risk and consider it when making treatment decisions.
This development could have far-reaching implications, prompting further research to gain a better understanding of the mechanisms behind this adverse event. It may also lead to efforts to develop strategies to mitigate its occurrence in individuals receiving semaglutide therapy.
Additionally, this new insight may trigger regulatory agencies to revisit and update prescribing information and guidelines. This would ensure the safe use of this medication in clinical practice, ultimately protecting patients’ health and wellbeing.
In spotlighting this issue, the medical community and regulators have shown their commitment to ensuring the safety of patients. Despite the benefits of semaglutide for diabetes and obesity, the potential risk of NAION underscores the need for careful consideration of the medication’s full safety profile. This development serves as a reminder of the importance of ongoing monitoring and research in the fast-paced world of biopharmaceuticals.
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