In a response to mounting evidence, the US Food and Drug Administration (FDA) announced today that the diabetes drug metformin can be used safely in patients with mild and, in some cases, moderate kidney impairment after decades of warning against it. Metformin previously had been contraindicated for patients with renal disease or dysfunction, as suggested by serum creatinine levels at or above 1.5 mg/dL for men and 1.4 mg/dL for women, or abnormal creatinine clearance. The FDA now says that after reviewing a number of studies, it has concluded that this contraindication is no longer necessary for certain patients with reduced kidney function.
The FDA is advising metformin manufacturers to revise their label information to incorporate both the new guidance and a new measure of kidney function to determine whether a patient should receive the drug. The new labels will recommend switching…
