Regulatory Focus™ > News Articles > New Studies Push FDA to Expand Label for Popular Diabetes Drugs

New Studies Push FDA to Expand Label for Popular Diabetes Drugs

Posted 08 April 2016 | By Zachary Brennan 

New Studies Push FDA to Expand Label for Popular Diabetes Drugs

Following a review of the medical literature, the US Food and Drug Administration (FDA) on Friday expanded the labels of 18 metformin-containing medicines for diabetes, noting that they can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function.

Prior to the label change, metformin, which at least one researcher has said is "little removed from a herbal remedy of the middle ages," was strongly recommended against use in some patients whose kidneys do not work normally. In addition to the expanded label, FDA is 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).

Approximately 14.4 million unique patients received a dispensed prescription for metformin or metformin-containing combination products from US outpatient retail pharmacies in 2014, FDA said.

The prescription-only drugs are used along with diet and exercise to lower blood sugar levels in patients with type 2 diabetes. Metformin-containing medicines include the brand and generic versions of:

Brand name

Active ingredient(s)

Actoplus Met

metformin and pioglitazone

Actoplus Met XR

metformin and pioglitazone, extended release


metformin and rosiglitazone


metformin extended release



Glucophage XR

metformin extended release


metformin and glyburide


metformin extended release


metformin and canagliflozin


metformin and sitagliptin

Janumet XR

metformin and sitagliptin, extended release


metformin and linagliptin


metformin and alogliptin

Kombiglyze XR

metformin and saxagliptin, extended release


metformin and repaglinide




metformin and empagliflozin

Xigduo XR

metformin and dapagliflozin, extended release


“Since FDA approved metformin in 1995, its labeling has included a contraindication against use in some patients with renal disease or dysfunction. We recently reviewed publications in the medical literature that show that metformin may be safely used in patients with mild to moderate renal impairment. In addition, published clinical trials, population-based studies, and retrospective case series in the United States and abroad indicate that metformin is often used in clinical practice outside of the current labeling indications and is prescribed to patients with mild to moderate chronic kidney disease,” FDA said.

FDA Drug Safety Announcement


Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.