The FDA ( Food and Drug Administration ) has required labeling changes regarding the recommendations for Metformin-containing medicines for diabetes to expand Metformin’s use in certain patients with reduced kidney function.
The current labeling strongly recommends against use of Metformin in some patients whose kidneys do not work normally.
FDA has reviewed numerous medical studies regarding the safety of Metformin use in patients with mild to moderate impairment in kidney function.
Metformin-containing medicines are available by prescription only and are used along with diet and exercise to lower blood sugar levels in patients with type 2 diabetes.
When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.
Metformin-containing medicines are available as single-ingredient products and also in combination with other drugs used to treat diabetes.
The current drug labeling strongly recommends against Metformin use in some patients whose kidneys do not work normally because use of Metformin in these patients can increase the risk of developing a serious and potentially deadly condition called lactic acidosis, in which too much lactic acid builds up in the blood.
FDA has concluded from the review of studies published in the medical literature that Metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function.
FDA is requiring changes to the Metformin labeling to reflect this new information and provide specific recommendations on the drug’s use in patients with mild to moderate kidney impairment.
We are also recommending that the measure of kidney function used to determine whether a patient can receive Metformin be changed from one based on a single laboratory parameter ( blood creatinine concentration ) to one that provides a better estimate of kidney function in patients with kidney disease ( i.e., glomerular filtration rate estimating equation [ eGFR ] ). ( Xagena )
Source: FDA, 2016