HUMALOG labeling warns that severe hypoglycemia can cause seizures or death, and that concentration or product mix-ups can cause overdose. Rapid insulin requires product-specific prescribing and monitoring; a short action profile does not make nonmedical use safe.[2]
- This label directly addresses lispro; other rapid products need their own formulation-specific instructions.
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 (setid c6b8ff07-d3e2-457f-8a38-b60de60adf75, SPL version 24, Effective Time 2025-04-01). Confirmed section 5.3 ("Severe hypoglycemia can cause seizures, may be life-threatening, or cause death"), section 5.4 (KwikPen-to-syringe overdosage warning), section 1 (Indications) and section 5.6 (Hypokalemia) verbatim. No correction needed; no qualified clinical review.