MFDS Revises Guide to GLP-1 Obesity Drugs, Strengthening Warnings for Adolescents and Pregnant Patients

The Ministry of Food and Drug Safety (MFDS) revised its guide to the safe use of GLP-1 obesity drugs, strengthening safety information for vulnerable groups, including adolescents and pregnant patients.

The MFDS said it distributed the “Guide to the Safe Use of GLP-1 Obesity Drugs” nationwide on the 30th to local medical associations and regional pharmacovigilance centers, in collaboration with the Korea Institute of Drug Safety and Risk Management.

The revised guide updates content that previously focused on adults. It covers conditions for which obesity drugs are used, proper administration, storage and disposal, precautions during treatment, and how to report adverse reactions.

For adults, GLP-1 obesity drugs are prescription medications for patients with obesity and an initial body mass index (BMI) of 30kg/㎡ or higher, or for patients who are overweight, have a weight-related comorbidity, and have a BMI of 27kg/㎡ or higher but less than 30kg/㎡.

The revised edition adds criteria for use in adolescents (ages 12 to under 18). Some products may be prescribed to adolescents with obesity whose initial BMI meets the adult threshold of 30kg/㎡ or higher and whose weight exceeds 60kg.

Because this is a period of growth and development, treatment should be started cautiously at a low dose. Clinicians should monitor the effects of inadequate nutrient intake or weight loss on growth, as well as adverse reactions such as dehydration caused by vomiting or nausea and acute pancreatitis.

Patients taking diabetes medications who also use GLP-1 obesity drugs may face an increased risk of low blood glucose and should consult their health care provider about whether their medication doses need adjustment.

Patients who are pregnant, breastfeeding or planning to become pregnant should stop treatment immediately and consult a health care professional. Caution is warranted because safety evidence for use during pregnancy is not yet sufficient. Those planning a pregnancy should use contraception for at least 1~2 months after stopping treatment, depending on the medication.

Before starting treatment, patients should tell a health care professional about any hypersensitivity to the medication, current medications, medical history, and whether they are pregnant or breastfeeding. Obesity drugs should be refrigerated away from light. Do not use or keep the medication if it has frozen, contains visible particles or has changed color; dispose of it instead.

Even when used within the approved indications, obesity drugs can commonly cause adverse events such as gastrointestinal disorders and injection-site reactions. Clinically important adverse events, including hypersensitivity reactions and acute pancreatitis, can also occur. Patients should notify a health care professional or visit a hospital if symptoms develop.

The MFDS emphasized that GLP-1 obesity drugs, which are prescription medications, must be used safely within their approved indications after a physician’s prescription and in accordance with a pharmacist’s dispensing and medication counseling. It urged patients to avoid online purchases from overseas and person-to-person sales or distribution because product safety cannot be guaranteed.

The educational materials are available on the MFDS website (www.mfds.go.kr) and the Korea Institute of Drug Safety and Risk Management website (www.drugsafe.or.kr).