MFDS calls for appropriate use of GLP-1 obesity drugs

MFDS issues notice to healthcare organizations urging appropriate prescribing, dispensing, and measures to prevent abuse and misuse

Recently, amidst the high popularity of GLP-1 receptor agonist obesity treatments, concerns over misuse and abuse, such as sharing high doses (splitting doses), illegal online distribution, and false/exaggerated advertising, have grown, putting health authorities on alert. In response, the Ministry of Food and Drug Safety has stepped up to urge medical institutions nationwide once again to ensure safe prescriptions and proper dosing.

According to healthcare organizations on the 31st, the Ministry of Food and Drug Safety (MFDS) recently issued an official notice requesting cooperation from healthcare providers on the appropriate use of GLP-1 class obesity treatments.

The move follows continued reports of patients obtaining higher-dose products and arbitrarily splitting doses to reduce costs, as well as repeated cases of illegal online sales and false or exaggerated advertising by medical institutions identified during inspections by local governments.

The MFDS emphasized that healthcare providers should ▲strictly adhere to approved storage conditions, including refrigeration, ▲prescribe and dispense the products only in accordance with their approved indications and dosing regimens, and ▲provide accurate patient counseling—including advising against dose splitting and warning against false or misleading advertising.

According to the ‘Safe Use Leaflet’ jointly developed by the MFDS and the Korea Institute of Drug Safety & Risk Management, GLP-1 obesity drugs including liraglutide, semaglutide and tirzepatide are prescription medicines intended for the treatment of obesity rather than cosmetic weight loss.

The approved treatment population is limited to ▲patients with a body mass index (BMI) of 30 kg/m² or higher or ▲ overweight patients with a BMI between 27 kg/m² and 30 kg/m² who also have obesity-related comorbidities such as type 2 diabetes, hypertension or dyslipidemia.

Administration of GLP-1 class obesity drugs

The regulator also stressed the importance of following proper dosing procedures to minimize adverse events. Treatment should always begin with the lowest recommended starting dose, followed by gradual dose escalation to allow patients to adapt to the medication. Arbitrarily administering higher doses may result in serious adverse reactions.

The drugs are contraindicated during pregnancy and breastfeeding. Women planning pregnancy should observe an appropriate washout period of at least two months after discontinuing Wegovy and at least one month after discontinuing Mounjaro, in consideration of the drugs' persistence in the body.  Patients receiving concomitant antidiabetic medications should consult their healthcare provider regarding dose adjustments because of the increased risk of hypoglycemia.

The MFDS also advised patients to seek immediate medical attention if they experience serious adverse events after treatment, including persistent upper abdominal pain (acute pancreatitis), right upper abdominal pain accompanied by fever (gallstones/cholecystitis), increased heart rate or anaphylaxis, in addition to common gastrointestinal adverse effects such as nausea, vomiting, and constipation.