Metformin hydrochloride (Glumetza®)
For more on this Drug Safety Labeling Change, click here.
For full prescribing information for Glumetza®, click here.

Updated Boxed Warning
Lactic Acidosis
Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (> 5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio, and metformin plasma levels generally > 5 µg/mL.
Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (eg, carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (eg, acute congestive heart failure), excessive alcohol intake, and hepatic impairment.
Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high-risk groups are provided in the full prescribing information.
If metformin-associated lactic acidosis is suspected, immediately discontinue GLUMETZA and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.
Public Information from the FDA and Medscape
Information provided by FDA and/or its employees on this website is for educational purposes only, and does not constitute medical advice. Any statement or advice given by an FDA employee on this website does not represent the formal position of FDA. FDA and/or any FDA employee will not be liable for injury or other damages resulting to any individuals who view FDA-related materials on this website.
Cite this: FDA Safety Labeling Changes: April-June 2017 - Medscape - Aug 31, 2017.