Welcome to FDA Drug Safety Podcasts for health care professionals. This is Lesley Navin Advanced Practice Nurse from the Division of Drug Information.
On April 8, 2016 FDA announced it is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function. The current labeling strongly recommends against use of metformin in some patients whose kidneys do not work normally. We were asked to review numerous medical studies regarding 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 metformin drug labeling that is used to determine whether a patient can receive metformin. We have concluded our review, and are requiring changes to the labeling of all metformin-containing medicines to reflect this new information.
Health care professionals should follow the latest recommendations when prescribing metformin-containing medicines to patients with impaired kidney function.
Metformin-containing medicines are available by prescription only and are used along with diet and exercise to lower glucose levels in patients with type 2 diabetes. Metformin-containing medicines are available as single-ingredient products and also in combination with other drugs to treat diabetes. The current drug labeling strongly recommends against metformin use in some patients whose kidneys do not work normally because use of metformin in these patients can increase the risk of developing lactic acidosis, a serious and potentially deadly condition.
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. We are requiring changes to the metformin labeling to reflect this new information and provide specific recommendations on the drug’s use in these patients.
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 that of eGFR (glomerular filtration rate estimating equation) which provides a better estimate of kidney function in patients with kidney disease.
Side effects involving metformin should be reported to the FDA MedWatch program at www.fda.gov/medwatch.
A link to the full communication including a list of FDA approved metformin-containing medicines and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at email@example.com.
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