Korea warns of rare vision-loss risk linked to GLP-1 drugs
Summary
The Ministry of Food and Drug Safety issued a safety alert Wednesday in Korea about a potential risk of rare vision loss associated with GLP-1 obesity drugs, including Wegovy and Mounjaro. The alert follows overseas regulatory actions concerning nonarteritic anterior ischemic optic neuropathy, or NAION. Medical professionals are advised to stop treatment and arrange immediate examination if NAION is suspected, while patients with related symptoms should contact their doctors. The ministry asked companies to submit safety information and plans for possible approval changes.
Key Facts
- The European Medicines Agency classified NAION as a very rare side effect of semaglutide in June last year and estimated it may affect up to 1 in 10,000 users.
- The U.S. Food and Drug Administration asked drugmakers Monday to add a possible increased risk of NAION to GLP-1 drug label warnings and precautions.
- Mounjaro was prescribed 1,501,161 times in Korea from its domestic launch last August through May this year, with monthly prescriptions rising from 18,579 to 273,140.
- People in their 30s accounted for 36 percent of Mounjaro prescriptions, followed by those in their 40s at 27.1 percent and those in their 20s at 16.9 percent.
- Wegovy was prescribed 1,228,867 times from its October 2024 launch through May this year, and people in their 20s and 30s accounted for 46.4 percent of prescriptions.
Novo Nordisk's obesity treatment drug Wegovy / AFP -Yonhap
The Ministry of Food and Drug Safety issued a safety alert Wednesday to medical professionals and patients over a potential risk of a rare eye condition associated with GLP-1 obesity drugs, including popular obesity treatments Wegovy and Mounjaro.
The move follows safety measures by overseas regulators concerning nonarteritic anterior ischemic optic neuropathy (NAION), a condition caused by reduced blood flow to the optic nerve that can lead to sudden, potentially permanent vision loss.
In June last year, the European Medicines Agency classified it as a very rare side effect of semaglutide, the active ingredient in Wegovy, estimating it may affect up to 1 in 10,000 users. The U.S. Food and Drug Administration asked drugmakers Monday to add a possible increased risk of NAION to the warnings and precautions on GLP-1 drug labels.
The letter advises medical professionals to stop treatment and have patients examined immediately if NAION is suspected in those taking GLP-1 drugs, which aid weight loss by mimicking a hormone that regulates appetite and blood sugar. Patients with related symptoms are advised to consult their doctors right away.
The food and drug ministry also asked companies selling GLP-1 drugs in Korea to submit data, including plans to amend their product approvals in light of the safety information. Based on the submissions, the ministry will consider revising the drugs’ usage precautions.
The safety measure comes amid surging demand for GLP-1 obesity treatments in Korea. According to drug utilization review data submitted by the Health Insurance Review and Assessment Service to Rep. Han Zee-a of the People Power Party in July, Mounjaro was prescribed 1,501,161 times from its domestic launch last August through May this year.
Monthly prescriptions rose about 14.7 times, from 18,579 in August last year to 273,140 in May this year. By age group, people in their 30s accounted for the largest share at 36 percent, followed by those in their 40s at 27.1 percent, those in their 20s at 16.9 percent and those in their 50s at 14.6 percent.
Wegovy was prescribed a cumulative 1,228,867 times from its October 2024 launch through May this year. People in their 20s and 30s accounted for 46.4 percent of that total.
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