MFDS will intensively monitor Wegovy and other obesity drugs

“Must be used cautiously in accordance with the approved indication prescribed by a medical professional.”

The Ministry of Food and Drug Safety (MFDS) has designated ‘Wegovy’ and other GLP-1-class obesity injectables as targets for intensive monitoring and plans to continuously monitor side effects in collaboration with the Korea Institute of Drug Safety & Risk Management.

 

Th MFDS designates the intensive monitoring status to drugs with high safety concerns in Korea and abroad, or those of high social interest due to concerns about misuse, and intensively collects, analyzes, and reevaluates their adverse events.

 

On the 25th, the MFDS emphasized that injectable GLP-1 class obesity drugs, which are currently attracting significant public attention, should only be used under the supervision of medical professionals for patients diagnosed with obesity, and only in accordance with the approved indication per prescription.

 

Injectable GLP-1 class obesity drugs are prescription drugs indicated for adult obese patients with an initial body mass index (BMI)* of 30 kg/m2 or higher, or adult overweight patients with a BMI of 27 kg/m2 or higher but less than 30 kg/m2 and one or more weight-related comorbidities such as hypertension.

 

According to clinical trial results, even when used within the approved indications, gastrointestinal adverse reactions (nausea, vomiting, diarrhea, constipation, etc.) and injection site reactions (rash, pain, swelling, etc.) are common, and serious adverse effects such as hypersensitivity reactions, hypoglycemia, acute pancreatitis, cholelithiasis, and fluid loss may occur.

 

Also, some medications are contraindicated in patients with underlying conditions such as thyroid medullary cancer, so consultation with a healthcare professional is mandatory.

 

In patients with type 2 diabetes, hypoglycemia and retinopathy may occur, so caution is particularly advised when administering such drugs to patients with relevant medical history.

 

Obesity treatments are prescription-only drugs that must be used under a doctor's prescription with the guidance of a pharmacist.

 

The MFDS urged the public not to purchase or distribute these medications through online platforms, overseas direct purchases, or personal sales.

 

Additionally, the Ministry of Food and Drug Safety recently urged companies holding the marketing authorization rights for the relevant products to prevent misuse and prohibit false advertising, and informed medical professionals about the proper use of obesity treatment medications within their approved scope.

 

The MFDS plans to publish an informational brochure (leaflet) in collaboration with the Korea Institute of Drug Safety & Risk Management, outlining the conditions for which obesity treatment drugs are used, proper administration methods, storage and disposal instructions, precautions during administration, and procedures for reporting adverse reactions (side effects).

 

The MFDS stated, "We will continue to strengthen the provision of information to improve users' understanding of obesity treatment drugs and ensure their safe use."