EMA assesses alertness on loss of vision in obesity medications

A European Medicines Agency today said that procedures are under way to include information on cases of non-arteritic anterior ischaemic optic neuropathy, which may cause loss of vision in information on injecting diabetes and obesity medicines.

“ Procedures are currently under way at the EMA [the European Agency’s English sigil] concerning the inclusion of information on non-arteritic anterior ischemic optic neuropathy [NAION] in the information on medicines Mounjaro (tirzepatida) and Trulicity (dulaglutide)”, the institution states in written response sent to the Lusa agency.

One day after warnings issued by the North American Medicines Agency (FDA), which announced the inclusion of new safety warnings in the information of GLP-1 receptor agonist medicinal products due to the possible risk of NAION, EMA reports on regulatory changes foreseen for these two medicinal products to update the respective Summary of Product Characteristics and package leaflets.

In the case of Mounjaro (tirzepatide), the proposal envisages adding information on the observation of cases of NAION associated with medicinal products with GLP-1 receptor agonist activity, based on data from clinical trials and post-marketing pharmacovigilance.

For Trulicity (dulaglutide), the proposed change has the same objective and is based on pharmacovigilance data and scientific literature.

“ Health professionals should consult the most up-to-date version of the information on medicines before prescribing them, as it contains the existing recommendations for their safe and effective use,” EMA added to Lusa, recalling that regulatory changes need to be approved by the European Commission.

The medicines used for diabetes and weight loss, such as Ozempic and Wegovy, will be alerted in the United States about a rare side effect that may lead to loss of vision, the American authorities announced on Thursday.

The Food and Drug Administration (FDA) revealed that the risk will be included in the package leaflet of all GLP-1 class drugs, highly successful drugs used in the treatment of obesity, diabetes and various other medical conditions.

This category covers about a dozen medicines available in the form of injection or tablets.

This ocular problem, known as anterior ischaemic optic neuropathy, may cause significant loss of vision.

According to the FDA, the problem - reported in association with all GLP-1 class drugs - occurs due to reduced blood flow to the optic nerve, although the underlying cause is not yet fully understood.

In Portugal, the National Medicines and Health Products Authority received, on average, a daily report of suspected adverse reactions to these medicines, such as vomiting, diarrhoea and hair loss.