[MFDS Card News] Ban imposed on manufacture and sale of 31 metformin drugs

       

Ban imposed on manufacture and sale of 31 metformin drugs

Ban on the production, distribution and prescription of 31 metformin products (anti-diabetic medication)

Total recall/testing of diabetes medication "metformin," including raw materials, and domestically manufactured or imported finished products, that are currently in circulation in Korea.

31 finished drugs, whose NDMA content found to exceed MFDS's safe levels*, suspended from production, distribution and administration.

*0.096ppm (daily intake of up to 1,000 mg)

*0.038ppm (daily intake of up to 2,550 mg)

If these drugs with excess NMDA were taken at the maximum dose from the date of approval to the end of this year, this will result in additional cancer risk of 0.21 cases in every 100,000 people exposed.

-> Health risk remains "extremely low"

Health risk from the use of these drugs with excess NMDA is minimal even after a long-term use.

"Don't stop taking any medication prescribed to you unless your doctor tells you to"

Talk with your doctor about the need to discontinue or change your current medications.

*How to check the list of withdrawn or restricted drugs

[Websites]

- Ministry of Food and Drug Safety website (www.mfds.go.kr)

- Drug Safety Information System website (nedrug.mfds.go.kr)

- Ministry of Food and Drug Safety blog (mfdsblog.com)

- Ministry of Food and Drug Safety Facebook page (www.facebook.com/mfds)

- Ministry of Health and Welfare website (www.mohw.go.kr)

- Naver portal site (www.naver.com)

[How to sesarch]

Search using the term "anti-diabetic medication," "Metformin" or "NDMA."

Please refer to the Press Release in Korean date May 26, 2020 for more information.

By - MFDS