Lactic Acidosis: The Metformin Boxed Warning | Dose Track
[Glossary · How doses act in the body]

Lactic acidosis

Also called metformin-associated lactic acidosis, MALA · Reviewed

Definition: Lactic acidosis is a build-up of lactic acid in the blood. It is the boxed warning on metformin labels, which say cases reported after approval have caused death. It is rare and often starts with vague symptoms such as feeling unwell, muscle aches, trouble breathing, sleepiness and stomach pain.

Risk factors on the label

The metformin label lists:

  • kidney impairment;
  • age 65 or older;
  • contrast dye scans and surgery;
  • low-oxygen states, such as acute heart failure;
  • heavy alcohol use and liver impairment;
  • some drugs, such as topiramate and other carbonic anhydrase inhibitors.

In reported cases, blood lactate was above 5 mmol/L. The Patient Information lists signs such as feeling very weak and tired, unusual muscle pain, trouble breathing, unusual sleepiness, feeling cold in the arms and legs, dizziness, or a slow or irregular heartbeat, and says to stop metformin and call the provider right away.

The kidney checks

The label ties metformin use to eGFR. It is contraindicated below 30 mL/min/1.73 m2 and not started between 30 and 45. Kidney function is checked before starting and at least once a year. The label also pauses metformin around some contrast scans and when food and fluids are restricted for surgery.

Why it matters for your log

The pause rules depend on dates: a scan, a procedure, a hospital stay. A log of when you paused and restarted, next to your eGFR results, helps every clinician see the timeline. This is a different acid problem from diabetic ketoacidosis, which metformin is contraindicated in.

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General education drawn from labels and published studies, not personal medical advice. Your prescriber, pharmacist and the label that came with your product are the final word.

Frequently asked questions

What is the metformin boxed warning?+
Lactic acidosis, a rare build-up of lactic acid in the blood that has caused deaths in cases reported after approval.
Why does metformin need kidney tests?+
Kidney impairment is a main risk factor for lactic acidosis. The label checks eGFR before starting and at least once a year, and it is contraindicated below 30.