The European Medicines Agency (EMA) will analyze a possible risk of a rare eye disorder in patients taking medications like Ozempic or Wegovy, based on the active ingredient semaglutide, indicated for treating diseases such as diabetes and obesity.
The safety committee of the European agency reported on Friday that it has started reviewing drugs containing semaglutide after two recent observational studies suggested a link between the medications and a higher risk of anterior ischemic optic neuropathy, a disorder caused by reduced blood flow to the optic nerve. This condition can lead to nerve damage and consequently vision loss.
In the information made public, the EMA reminds that patients with type 2 diabetes may already have a higher risk of developing this eye problem due to circumstances inherent to the disease.
Furthermore, it also notes that two other observational studies conducted with semaglutide-based medications did not observe this increased risk.
The eye disorder mainly affects individuals over 50 years old, often in the presence of atherosclerotic risk factors such as high blood pressure, diabetes, and smoking. It typically presents with a sudden, painless, and unilateral vision loss.
As clarified by the EMA in a statement, the review will consider all available data to assess this potential risk in clinical trials, post-marketing surveillance, studies on the drug's mechanism of action, as well as medical literature.
Semaglutide belongs to the family of glucagon-like peptide-1 (GLP-1) receptor agonists, a group of drugs that have revolutionized the treatment of metabolic diseases.
According to data from one of the cited observational studies published in July last year in the journal JAMA Ophthalmology, diabetic patients treated with semaglutide had four times higher risk of developing optic neuropathy compared to patients not taking a GLP-1 agonist. This finding was based on an average follow-up of almost three years.
The researchers of the study, with Joseph Rizzo III from the Massachusetts Eye and Ear at Harvard University in Boston as the lead author, stated in the scientific journal that the study "is the first, to our knowledge, to report an association" between semaglutide and the optic disorder, "although our study design did not allow for investigating a causal relationship between the two"; thus, they advocated for further studies to delve into the association.
The study followed 710 type 2 diabetes patients (median age 59 years; 52% women), of whom 194 were taking semaglutide and 516 a different antidiabetic from the GLP-1 class. And 979 overweight or obese patients (median age 47 years; 72% women), with 361 on semaglutide and 618 prescribed a weight-loss medication outside this drug family.
Last spring, following a similar review, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded that the current available evidence does not support a causal association between glucagon-like peptide-1 receptor agonists (GLP-1) and medications from the Ozempic family with suicidal and self-injurious thoughts and actions.