UPDATE : Monday, September 7, 2020
상단여백
HOME Pharma
Metformin warnings to include lactic acidosis death case
  • By Lee Hye-seon
  • Published 2018.02.23 14:43
  • Updated 2018.02.23 18:42
  • comments 0

Metformin, a first-line treatment for diabetes, will have to add lactic acidosis, an abnormal buildup of lactic acid in the blood, to the list of death-causing complications, the government said Tuesday.

The Ministry of Food and Drug Safety said it would change approval conditions for metformin-active single treatments and combination drugs.

Although lactic acidosis is a rare disorder, it can easily occur in patients with acute renal failure, cardiopulmonary diseases, and sepsis. Thus, it is desirable for diabetic patients to manage blood sugar levels at all time strictly.

Metformin-containing combo drugs that face a change in approval conditions are those combined with linagliptin, sitagliptin, alogliptin, and pioglitazone.

In addition to the warning about lactic acidosis, metformin drugs will have to state that it should not be administered to patients with diabetic coma and serious renal disorder (with glomerular filtration rate less than 30 ml/min), and lactic acidosis.

The change in metformin approval conditions is a follow-up measure to the review by the Korean health authorities over the latest safety information of metformin released by the European Commission and the U.S. Food and Drug Administration.

A total of 329 pharmaceutical products by 114 drugmakers will be subject to the change. Companies that have a different opinion about the change can submit related data and reason to the MFDS’ drug safety evaluation division by March 7.

lhs@docdocdoc.co.kr

<© Korea Biomedical Review, All rights reserved.>

Other articles by Lee Hye-seon
iconMost viewed
Comments 0
More
Please leave the first comment.
여백
여백
여백
Back to Top