“FDA’s drug safety communication applies to all medicines with GLP-1 RA activity and does not reference any findings specific to Lilly medicines,” said a Lilly spokesperson, according to CNN. “We are carefully evaluating the update and will respond to FDA promptly.”
NAION is a rare condition that can cause rapid-onset vision changes and loss that can result in blindness. It typically occurs in people over the age of 50 and is usually permanent. While the underlying cause has yet to be completely understood, this condition is believed to be caused by a decrease in blood flow to the front section of the optic nerve.
This news comes after a number of lawsuits were filed by GLP-1 users who say they were not sufficiently warned that taking the drug could result in vision loss. Before the FDA ruled on updating GLP-1 warning labels, NAION was not listed on the medication’s packaging in the U.S., but is included in some other countries.
In June, Novo Nordisk updated labels for Wegovy and Ozempic in Europe to read that semaglutide, an active ingredient in weight-loss drugs, may cause NAION in one in 10,000 patients.
Evidence linking GLP-1 medications and NAION is mixed. While some research has suggested a possible association, other studies have found no correlation between the two. In May, The American Academy of Ophthalmology said there was insufficient evidence for a blanket warning, writing “causality has not been established.”
What do GLP-1 makers say?
“Patient safety is Lilly’s top priority,” Eli Lilly said in a statement to Moneywise.
“We actively monitor, evaluate and report safety information for all our medicines to the FDA. As part of our routine safety review process, we have ongoing discussions with regulators regarding potential safety topics and we will continue to review data, including any data regarding ophthalmic issues. If anyone is experiencing side effects when taking a Lilly medicine, they should talk to their doctor or other healthcare professional.”
Novo Nordisk said it believed the personal injury lawsuits filed against the company were “without merit and we are defending them.”
“Patient safety is a top priority for Novo, and we take all reports of adverse events seriously,” Liz Skrbkova, head of U.S. media and stakeholder relations for Novo, told Moneywise. “We care deeply about the wellbeing of people who take our medicines and collaborate closely with health authorities and regulatory bodies worldwide.
