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Changes made to labeling of metformin-containing medications
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The FDA recently announced labeling changes for diabetes medications that contain metformin to expand their use in certain patients with reduced kidney function, according to a press release.
Currently, labeling advises against the use of metformin-containing medications in some patients with reduced kidney function.
The FDA reviewed studies on the safety of metformin use in patients with mild to moderate kidney dysfunction and is now recommending that metformin can be safely used in patients with mild kidney impairment and in some patients with moderate impairment. The agency is further recommending that kidney function be measured using estimated glomerular filtration rate rather than blood creatinine concentration to determine whether a patient can receive metformin-containing medications.
The FDA advises health care providers to follow the new recommendations and patients to speak with their providers if they have concerns.
Perspective
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Sean Hennessy, PharmD, PhD
Metformin is, simply put, the best-proven oral drug for diabetes.
However, many people with diabetes have mild to moderate renal insufficiency, which until now has kept them from taking metformin because of overly cautious warning statements in drug's label. FDA's recent decision to remove these overly cautious warnings will permit many more patients to take this proven therapy. FDA's decision will therefore benefit many people living with diabetes.
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