Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Revised Labeling for Metformin-Containing Drugs
FDA press release; 2016 Apr 8
FDA is requiring labeling changes that expand metformin’s use in certain patients with reduced kidney function. Among the changes:
• Before starting metformin, obtain the patient’s eGFR.
• Metformin is contraindicated in patients with an eGFR below 30 mL/minute/1.73 m2.
• Starting metformin in patients with an eGFR between 30 and 45 mL/minute/1.73 m2 is not recommended.
• Obtain an eGFR at least annually in all patients taking metformin, and more frequently in those at risk of renal impairment.
• In patients taking metformin whose eGFR later falls below 45 mL/minute/1.73 m2, assess the benefits and risks; discontinue treatment if eGFR falls below 30 mL/minute/1.73 m2.
• Discontinue metformin before an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/minute/1.73 m2. Re-evaluate eGFR 48 hours after the procedure, and restart metformin if renal function is stable.
Citation: Metformin-containing drugs: Drug safety communication - revised warnings for certain patients with reduced kidney function [news release]. Silver Spring, MD: FDA; April 8, 2016. http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm494829.htm. Accessed April 12, 2016.