EU Regulator to Investigate Potential Link Between Ozempic and Eye Disorders
Investing.com -- The European Medicines Agency (EMA), the pharmaceutical regulator of the European Union, announced on Wednesday that it will investigate a possible link between Novo Nordisk's popular diabetes drug Ozempic and a rare eye condition that can lead to vision loss. This move comes in response to recent scientific studies raising concerns about this potential connection.
The eye condition in question is nonarteritic anterior ischemic optic neuropathy (NAION), caused by a loss of blood flow to the optic nerve. The EMA will assess data from these studies to determine whether the main ingredient of Ozempic is associated with NAION.
Novo Nordisk, the most valuable company in Europe, has seen a significant increase in sales thanks to the success of Ozempic and its sibling weight loss drug Wegovy. However, the potential side effects of these drugs have recently come under scrutiny.
The EMA's review was prompted by two studies from the University of Southern Denmark that suggested a higher risk of developing NAION in patients using Ozempic. Novo Nordisk responded by emphasizing its commitment to take all adverse event reports related to its medications seriously. The company stated that the studies did not establish a causal relationship between semaglutide – the active ingredient in both Ozempic and Wegovy – and NAION.
Novo Nordisk also noted that its internal safety assessment and research evaluations concluded that the benefit-risk profile of semaglutide remained unchanged.
The EMA's safety committee is currently assessing whether the risk of developing NAION is increased in patients treated with semaglutide. The regulatory agency indicated that the evidence available prior to these recent studies was not sufficiently robust to establish a potential link.
Research from the University of Southern Denmark showed an increased risk of optic nerve damage in patients with type 2 diabetes using Ozempic. However, they did not establish a direct connection between the drug and the condition, noting that the absolute risk remained low among patients using Ozempic.
These findings were consistent with results from a smaller-scale study by Harvard researchers, which was the first to suggest an increased risk of NAION associated with semaglutide, but did not prove causality.