European Medicines Agency to investigate link between Ozempic and rare eye disorder
The safety committee of the European Medicines Agency (EMA) will again study the medication, semaglutide, out of concerns that it may increase the risk of a rare eye condition, the Amsterdam-based agency announced on Friday. The generic medication is sold as treatment for diabetes and obesity under several brand names, including Ozempic, Rybelsus, and Wegovy.
Ozempic, in particular, has become very popular with people trying to lose weight. There have also been reports of illegal trading when it comes to the drug.
“EMA’s safety committee, the PRAC, has started a review of medicines containing semaglutide following concerns regarding an increased risk of a non-artheritic anterior ischemic optic neuropathy (NAION), a rare eye condition, as suggested in two recent observational studies, while two other recent observational studies do not suggest an increased risk,” the EMA stated.
"This is a disorder caused by reduced blood flow to the optic nerve in the eye with potential damage to the nerve, which can lead to loss of vision in the affected eye. Patients with type 2 diabetes might already have an inherently higher risk of developing this condition."
NAION causes acute diminished vision in one eye, but rarely both. Decreased blood circulation to the optic nerve can also be due to factors such as severe blood pressure changes or blood loss during surgery. A study published by the American Academy of Ophthalmology also noted that roughly 10 percent of NAION patients suffer from discomfort or pain in and around the eyes and headaches.
Semaglutide is used to reduce the amount of sugar in the blood. Researchers will be asked to provide the committee with a fresh look at how the substance produces this effect.
The EMA committee will also investigate whether semaglutide can be proven to increase the risk of reduced blood flow to the optic nerve. The PRAC will review clinical trial data, research carried out on patients after the drugs entered the market, observational studies, and relevant literature.
