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FDA eases restrictions on metformin use in renal impairment

Friday, 8 April 2016   (0 Comments)
Posted by: Psgh Editor
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The US FDA today in a drug safety communication required labeling changes on  metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function (eGFR<90ml/min/1.73m2). The current labeling strongly recommends against use of metformin in some patients whose kidneys do not work normally because use of metformin in these patients can increase the risk of developing a serious and potentially deadly condition called lactic acidosis, in which too much lactic acid builds up in the blood.

The agency was tasked to review current studies regarding the safety of metformin use in patients with mild to moderate impairment in kidney function (eGFR 30-89ml/min/1.73m2). The agency today reports that "We have concluded our review, and are requiring changes to the labeling of all metformin-containing medicines to reflect this new information."

It further urged health professionals to follow the latest recommendations when prescribing metformin-containing medicines to patients with impaired kidney function. 

Following the review of the current medical studies regarding metformin use in renal impairment, FDA now contends that "metformin can be used safely in patients with mild impairment (eGFR 60-89ml/min/1.73m2) in kidney function and in some patients with moderate impairment in kidney function (eGFR 30-59ml/min/m2), adding, "We are requiring changes to the metformin labeling to reflect this new information and provide specific recommendations on the drug’s use in patients with mild to moderate kidney impairment."

Find below sections of the statements accompaining the release:

  • We are also requiring manufacturers to revise the labeling to recommend 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 renal function (i.e., glomerular filtration rate estimating equation (eGFR)).  This is because in addition to blood creatinine concentration, the glomerular filtration rate takes into account additional parameters that are important, such as the patient’s age, gender, race and/or weight.
  • The labeling recommendations on how and when kidney function is measured in patients receiving metformin will include the following information:
    • 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 30-45 mL/minute/1.73 m2 is not recommended.
    • Obtain an eGFR at least annually in all patients taking metformin. In patients at increased risk for the development of renal impairment such as the elderly, renal function should be assessed more frequently.
    • In patients taking metformin whose eGFR later falls below 45 mL/minute/1.73 m2, assess the benefits and risks of continuing treatment.  Discontinue metformin if the patient’s eGFR later falls below 30 mL/minute/1.73 m2.
    • Discontinue metformin at the time of or before an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/minute/1.73 m2; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast.  Re-evaluate eGFR 48 hours after the imaging procedure; restart metformin if renal function is stable.