Korea tightens safety guidance for GLP-1 weight-loss drugs

The food and drug safety ministry said Wednesday it has distributed revised safety guidance for GLP-1 obesity treatments, adding dosing criteria for adolescents and stronger precautions for pregnant and breastfeeding patients.

The guidance, issued jointly with the Korea Institute of Drug Safety and Risk Management and sent to regional medical associations and drug safety centers nationwide on Sept. 30, replaces an earlier edition written mainly for adults. It covers conditions the drugs are used to treat, injection methods, storage and disposal, precautions during use and how to report adverse reactions.

GLP-1 drugs mimic the hormone glucagon-like peptide 1 to suppress appetite and prolong fullness, producing weight loss. For adults they are prescription-only treatments for patients with an initial body mass index of 30 kilograms per square meter or higher, or for overweight patients with a BMI of 27 to below 30 who also have at least one weight-related condition such as Type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease. The revised guidance states for the first time that adolescents aged 12 to under 18 may be prescribed some products containing semaglutide or liraglutide, but only if their initial BMI meets the adult threshold of 30 or higher and they weigh more than 60 kilograms.

Patients taking diabetes medication who also use a GLP-1 obesity drug may face a greater risk of low blood sugar and should discuss dose adjustments with their doctor. Women who are pregnant, breastfeeding or planning a pregnancy should stop the treatment immediately and consult a specialist, the guidance says, because evidence on safety during pregnancy remains insufficient. Those planning a pregnancy should stop the drug in advance and observe a contraception period of at least one to two months after stopping, depending on the product.

Before treatment, patients should tell their medical professional about any allergic reaction to the drug, other medications they are taking, their medical history and whether they are pregnant or breastfeeding. The drugs should be kept refrigerated and protected from light, and discarded without use if the medicine has frozen or if particles or a color change appear.

Even within approved uses, common side effects include gastrointestinal disorders and injection-site reactions, while clinically significant reactions such as hypersensitivity and acute pancreatitis can also occur. Adolescents need monitoring for how poor nutrition or weight loss affects their growth, and for signs of dehydration from vomiting or nausea and for reactions such as acute pancreatitis.

The ministry stressed that GLP-1 obesity drugs are prescription medicines and must be used within approved limits under a doctor's prescription and a pharmacist's dispensing guidance. It advised against buying them through overseas online shopping or person-to-person sales, saying the safety of products obtained that way cannot be guaranteed.