FDA Announces Changes to Labeling of Diabetes Medication Metformin

April 8, 2016

The Food and Drug Administration (FDA) is requiring new changes to labeling of medications containing metformin to expand metformin’s use in certain patients with reduced kidney function. Metformin is commonly prescribed to patients with type-2 diabetes.

This requirement comes after numerous medical studies revealed that metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function. Currently, labeling for metformin strongly recommends against the use of metformin in some patients whose kidneys do not work normally. 

The FDA also recommends 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, or eGFR).

Get more information, including recommendations for health care professionals and patients regarding metformin, at the FDA website.

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