Introduction
The European Medicines Agency (EMA) has concluded that the use of Wegovy, a popular weight-loss drug by Novo Nordisk, and the company’s diabetes type 2 treatments Ozempic and Rybelsus, may rarely cause a potentially dangerous eye condition.
The Eye Condition: Neuropatía Óptica Ischemica Anterior No Arterítica (NOIA-NA)
The condition, known as Neuropatía Óptica Ischemica Anterior No Arterítica (NOIA-NA), affects approximately 1 in every 10,000 individuals taking semaglutida, the active ingredient in Wegovy and Novo Nordisk’s diabetes medications Ozempic and Rybelsus. The EMA announced this finding on Friday.
Understanding NOIA-NA
NOIA-NA is caused by insufficient blood flow to the optic nerve, leading to sudden and painless vision loss in one eye. It is the second most common cause of optic nerve damage-related blindness, following glaucoma.
EMA’s Investigation and Findings
The EMA initiated its review in December of the previous year. The committee determined that using these medications doubles the risk of developing NOIA-NA compared to those not taking them.
Previous studies had linked semaglutida to NOIA-NA, but this is the first time a regulatory body has established such a relationship.
Semaglutida and GLP-1 Receptor Agonists
Semaglutida belongs to a class of drugs called GLP-1 receptor agonists, which help regulate blood sugar levels and create a feeling of fullness.
Supporting Evidence
A large study of nearly 350,000 diabetics published earlier this year demonstrated that the risk of developing NOIA-NA more than doubled with prolonged use of semaglutida compared to patients taking other classes of medications.
EMA’s Recommendation
After reviewing all available data on NOIA-NA associated with semaglutida, including non-clinical studies, clinical trials, and post-marketing surveillance, the EMA recommended that Novo Nordisk update prescription information for medications containing semaglutida to include NOIA-NA as a rare side effect.
Response from the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (FDA) did not respond immediately to a Reuters request for comments.
Key Questions and Answers
- What is NOIA-NA? Neuropatía Óptica Ischemica Anterior No Arterítica (NOIA-NA) is a rare eye condition causing sudden and painless vision loss due to insufficient blood flow to the optic nerve.
- Which medications are associated with NOIA-NA? The EMA has linked Wegovy (a weight-loss drug) and Novo Nordisk’s diabetes medications Ozempic and Rybelsus (which contain semaglutida) to NOIA-NA.
- How does using these medications increase the risk of NOIA-NA? The EMA found that using these medications doubles the risk of developing NOIA-NA compared to not using them.
- What action has the EMA taken? The EMA recommended that Novo Nordisk update prescription information for medications containing semaglutida to include NOIA-NA as a rare side effect.
- Has the U.S. FDA responded? The U.S. Food and Drug Administration did not respond to a Reuters request for comments.
