FDA Drug Safety Communication: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function

The U.S. Food and Drug Administration (FDA) is requiring 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. We were asked1,2 to review numerous medical studies regarding the safety of metformin use in patients with mild to moderate impairment in kidney function,3-14 and to change the measure of kidney function in the metformin drug labeling that is used to determine whether a patient can receive metformin. We have concluded our review, and are requiring changes to the labeling of all metformin-containing medicines to reflect this new information.

Helene Clayton-Jeter, O.D.
Office of Health and Constituent Affairs
Food and Drug Administration

For more information about the Cardiovascular & Endocrine Liaison Program visit the FDA Patient Network