LANTUS labeling warns that severe hypoglycemia can cause seizures or death, and its long action may delay recovery from hypoglycemia. Changing insulin type or concentration can alter glucose control.[2]
- Direct label evidence for glargine U-100; the directory category also includes other products with different properties.
Inspection history
Clinical review: not reviewed by a qualified clinician.
· Independent source inspection; applicability narrowed and inherited assertions excluded where unsupported. No qualified clinical review.
· Independently reopened the current DailyMed label pinned to version 35 (Effective Time 2025-06-02). Confirmed section 5.3 ("Severe hypoglycemia can cause seizures, may be life-threatening or cause death"; "The long-acting effect of LANTUS may delay recovery from hypoglycemia") and section 5.2 (insulin-regimen changes, including strength/manufacturer/type, affecting glycemic control) verbatim. No correction needed; no qualified clinical review.