Canagliflozin label carries boxed warning for lactic acidosis

The FDA-listed KAZANO label included a boxed warning for lactic acidosis effective 17 August 2026. The warning states that postmarketing cases of metformin-associated lactic acidosis resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The supplied record identifies canagliflozin among the associated drug names and lists metformin hydrochloride in the product information.

Background

The event concerns a label revision involving KAZANO and the warning for metformin-associated lactic acidosis. The supplied data do not provide additional information about the product’s approved indications, dosing, pharmacologic mechanism, patient eligibility, or the prevalence of lactic acidosis. They also do not describe a new approval or a change to the indication for canagliflozin.

What changed

The label carried a boxed warning titled “WARNING: LACTIC ACIDOSIS”. Its postmarketing safety statement says that cases associated with metformin have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The warning also says that onset is often subtle, although the supplied summary ends before providing the remainder of that statement.

What this means

The label record highlights a serious safety warning involving metformin-associated lactic acidosis. The listed outcomes indicate that the warning addresses potentially fatal and severe cardiovascular and temperature-related complications reported after marketing. The supplied data do not provide case counts, incidence estimates, risk factors, management instructions, comparative safety findings, or evidence that the revision changed canagliflozin’s efficacy or approved use.

Because the event is a label revision rather than a clinical-trial results posting, the record contains no trial phase, enrollment total, comparator arm, endpoint analysis, p-value, or confidence interval. It also does not establish whether the boxed warning was newly added or confirms that it was present on the label effective on the stated date.

Source

Source: U.S. Food and Drug Administration, DailyMed label document for KAZANO, effective 17 August 2026. The source is available through the DailyMed label record at dailymed.nlm.nih.gov.