Other safety alerts
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| European Union: Medicines containing semaglutide: PRAC investigating risk of rare eye condition (NAION) |
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European Medicines Agency (EMA) announces that its Pharmacovigilance Risk Assessment Committee (PRAC), has started a review of medicines containing semaglutide following concerns regarding an increased risk of developing non-arteritic anterior ischemic optic neuropathy (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
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-13-16-january-2025
In Hong Kong, there are 11 registered pharmaceutical products containing semaglutide. All products are prescription-only medicines. So far, the Department of Health (DH) has received 10 cases of adverse drug reaction related to semaglutide, but these cases are not related to NAION. In light of the above EMA’s announcement, the DH will remain vigilant on the conclusion of the review and any safety update issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Saturday, Jan 18, 2025
Issued at HKT 12:00
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