FDA is requiring a class labeling change that will allow many more diabetes patients to benefit from metformin.
Metformin is effective, inexpensive, and may facilitate weight loss and reduce the risk of cardiovascular events.
Historic concerns regarding the use of metformin originate from the ability of the drug to cause lactic acidosis, especially in patients with CKD.
FDA review of a large body of data suggests that metformin may be safely used in mild-moderate renal impairment. eGFR should replace SCr as measure of renal function.
The US Food and Drug Administration (FDA) released a Drug Safety Communication in April revising warnings regarding the use of metformin in certain patients with diabetes and reduced kidney function. It is requiring a labeling change by manufacturers of all metformin and metformin-containing drugs. Current labeling, in place since the approval of metformin in 1985, strongly recommends against use of metformin in patients with renal disease or renal dysfunction (eg, SCr levels â¥1.5 mg/dL [men], â¥1.4 mg/dL [women] or abnormal creatinine clearance.FDA also is requiring that labeling recommend use of eGFR rather than SCr to evaluate renal function. The systematic review behind the FDA action was published in the Journal of the American Medical Assocation.Â The 7 slides above provide a quick clinical update on the FDA guidance.