The Spanish Agency for Medicines and Health Products (AEMPS) and the Ministry of Health alert the risk of non -arteritic ischemic optical neuropathy (NOIANA) in patients treated with semaglutida, a compound included in Ozempic, Rybelsus and Wegovy medications, which are commonly used for the treatment of diabetes mellitus type 2 and obesity.
From the AEMPS they wanted to report this danger, which could mean the loss of vision suddenly for those who consume the 3 medications mentioned, which include the active substance of the semaglutida.From the Committee for the Risk Assessment in Pharmacovigilance (PRAC) of the European Medication Agency (EMA), the risk of developing Noiana has been analyzed, an eye condition that can cause loss of sudden vision.
Causes a possible loss of vision
The Noiana is an eye condition that causes sudden and painless loss of vision in an eye due to a decrease in blood flow to the optical nerve.It is the second most common cause of optical neuropathy after glaucoma and usually affects people over 50 with risk factors such as diabetes, hypertension or sleep apnea.
This condition is directly associated with the use of semaglutida.In fact, a study published in Jama Ophthalmology found that patients with psemaglutid treaties had a risk 4.28 times higher to develop Noiana compared to those used by other antidiabetics.In people with overweight or obesity, the risk was 7.64 times higher.
During the PRAC and EMA review, the clinical and preclinical trial data, adverse reactions and scientific bibliography suspicion data were evaluated, concluding that trailer treatment is associated with a risk of developing this condition.The frequency of appearance is very rare, being able to affect 1 in 10,000 people according to the data of the clinical trials.
Of course, the conclusions of the evaluation carried out by the PRAC must be ratified by the Human Use Medicines Committee (CHMP) of the EMA, of which all European medicine agencies are part.
When confirmed by the CHMP, the technical file and the prospect of these medications will be updated to reflect this new information.That is, the Niana will be included as a side effect more of its use.These documents are available at the AEMPS (CIMA) online medication information center.