FDA Revises Metformin Warnings

After reviewing a number of medical studies, the FDA has decided to require label changes regarding the use of metformin-containing drugs.

Previously, the agency’s labeling “strongly recommends against use of metformin in some patients whose kidneys do not work normally,” according to an FDA statement.

The agency was asked to review a number of medical studies show the safety of metformin use in patients with mild to moderate impairment in kidney function and to “change the measure of kidney function” in the drug labeling.

“We have 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,” the FDA noted in a statement. “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)).”

All labeling will reflect this going forward.

Click here to read the safety communication.

--Stephanie Vaccaro

Reference:

1. U.S. Food and Drug Administration. FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function. FDA Safety Communication. www.fda.gov. 2016 Apr 8.