U.S. FDA's "Blindness Risk from Weight-Loss Drugs" Warning Prompts MFDS Safety Measures

Drug safety letter distributed to medical professionals and patients
GLP-1 drug suppliers asked to submit materials

The U.S. Food and Drug Administration (FDA) has decided that warning language about the risk of optic nerve damage must be added to all glucagon-like peptide-1 (GLP-1) medications, including Wegovy and Mounjaro. South Korean authorities have also begun taking safety measures. They will advise medical professionals and patients to stop taking the medication and seek immediate medical attention if vision problems are suspected during treatment, and are considering reflecting the information in the domestic approval requirements.

On November 11, the Ministry of Food and Drug Safety (MFDS) said it had distributed a drug safety communication to medical professionals, including doctors and pharmacists, and to patients, based on overseas safety information indicating that GLP-1 medications may increase the risk of non-arteritic anterior ischemic optic neuropathy (NAION). The active ingredients covered are tirzepatide (Mounjaro), semaglutide (Wegovy and Ozempic), liraglutide (Saxenda), and efpeglenatide (Epe).

NAION is a condition in which the optic nerve is damaged because it does not receive an adequate blood supply. It can cause sudden vision loss in one eye and, in severe cases, may lead to blindness.

According to the communication distributed by the MFDS, medical professionals should advise patients being treated with GLP-1 medications to stop taking them and seek immediate medical attention if NAION symptoms are suspected. The MFDS also asked pharmaceutical companies that supply GLP-1 medications in South Korea to submit materials, including plans for changes to their product approvals. Based on these materials, the ministry plans to consider whether to add relevant information to the precautions for use.

The measure follows a recent FDA decision. On November 9 (local time), the FDA ordered that the risk of NAION be added to the "Warnings and Precautions" section of the approval information for all 12 GLP-1 products authorized in the United States. An FDA analysis of 126 clinical trials involving 78,217 patients treated with GLP-1 medications found that the incidence of NAION was higher in the GLP-1 treatment group, at 6.4 cases per 100,000 person-years, than in the comparison group, at 3.8 cases. This means that the condition occurs in about 6.4 people for every 100,000 who take the medication for one year.

The FDA said that while GLP-1 medications may increase the risk of NAION, the condition itself is rare and the mechanism behind the risk has not been confirmed.

An MFDS official said, "We have monitored this adverse event associated with GLP-1 obesity treatments and taken necessary measures, including changing their approval information. We will continue to do our utmost to ensure the safety of medicines."

This content was produced with the assistance of AI translation services.