Partial
Partially Aligned
Patient Risk:
Moderate
Summary
Many mechanism/indications and several monitoring/toxicity and interaction concepts align with the label; however, multiple claims are unsupported by the provided label text, and a potentially material safety omission/mapping issue is present regarding digoxin toxicity manifestations (e.g., confusion/CNS).
Category Scores
Accurate Statements
Digoxin is a cardiac glycoside.
11 DESCRIPTION
Digoxin is used to treat mild to moderate heart failure in adults.
1.1 Heart Failure in Adults
Digoxin is indicated for control of ventricular response rate in adult patients with chronic atrial fibrillation.
1.3 Atrial Fibrillation in Adults
Digoxin increases left ventricular ejection fraction and improves heart failure symptoms (improving exercise capacity and decreasing heart failure-related hospitalizations and emergency care).
1.1 Heart Failure in Adults
Digoxin increases the force of myocardial systolic contraction (positive inotropic action).
12.1 Mechanism of Action
Digoxin decreases conduction velocity through the AV node.
12.1 Mechanism of Action
Dosing is important to consider factors affecting digoxin blood levels (e.g., body weight, age, renal function, concomitant drugs) because toxic levels are only slightly higher than therapeutic levels.
2.1 Important Dosing and Administration Information
Monitor for signs and symptoms of digoxin toxicity and clinical response; adjust dose based on toxicity, efficacy, and blood levels.
2.5 Monitoring to Assess Safety, Efficacy, and Therapeutic Blood Levels
Obtain serum digoxin levels in patients with signs or symptoms of digoxin therapy and interrupt/adjust dose if necessary.
5.3 Digoxin Toxicity
Signs/symptoms of digoxin toxicity include nausea and vomiting; anorexia.
5.3 Digoxin Toxicity
Signs/symptoms of digoxin toxicity include cardiac arrhythmias.
5.3 Digoxin Toxicity
Toxicity is usually associated with digoxin levels >2 ng/mL.
5.3 Digoxin Toxicity
Low body weight, advanced age, or impaired renal function and electrolyte abnormalities (hypokalemia, hypercalcemia, hypomagnesemia) may predispose to digoxin toxicity.
5.3 Digoxin Toxicity
Assess serum electrolytes and renal function periodically.
5.3 Digoxin Toxicity
Digoxin has a narrow therapeutic index (requires increased monitoring).
7 Drug Interactions (intro)
When drugs may interact with digoxin, measure serum digoxin concentrations before initiating concomitant drugs and continue monitoring (dose reduction/adjustment guidance provided in the label).
7.2 Pharmacokinetic Drug Interactions
Certain pharmacodynamic drug interactions can affect arrhythmia risk or AV node conduction (e.g., epinephrine/norepinephrine/dopamine increasing arrhythmia risk; beta-adrenergic blockers and calcium channel blockers additive AV node conduction effects).
7.3 Potentially Significant Pharmacodynamic Drug Interactions
Antiarrhythmics such as amiodarone and dronedarone are listed in the pharmacokinetic interaction table and/or have pharmacodynamic interaction warnings related to risk.
7.2 Pharmacokinetic Drug Interactions; 7.3 Potentially Significant Pharmacodynamic Drug Interactions
Renal impairment generally demonstrates prolonged digoxin elimination half-lives and greater exposures; titrate carefully and use serum digoxin concentration monitoring as appropriate.
12.3 Pharmacokinetics (Renal Impairment)
Unsupported Statements
Digoxin injection is a sterile, injectable form of digoxin.
Provided label excerpts do not state sterility or injectability for a digoxin injection product.
Digoxin injection is typically used in a hospital setting when an injectable option is needed rather than oral dosing.
Provided label excerpts do not describe typical hospital use patterns or injectable-vs-oral selection criteria.
Digoxin is used for certain types of atrial flutter.
Provided label excerpts include atrial fibrillation (chronic) only; no atrial flutter indication is present in the provided sections.
Digoxin is used to help control heart rate in atrial fibrillation or atrial flutter.
Label excerpt supports ventricular response rate control for chronic atrial fibrillation but does not mention atrial flutter.
Signs of digoxin toxicity can include confusion.
The provided label toxicity symptom list does not include confusion (it lists anorexia, nausea, vomiting, visual changes, and a range of cardiac arrhythmias/blocks).
Digoxin injection products and brands can vary by manufacturer and formulation.
Provided label excerpts do not address brand/manufacturer variability for injection products.
Digoxin injection formulations can vary in concentration.
Provided label excerpts do not discuss injection formulation concentrations.
Digoxin injection formulations can vary in vial type.
Provided label excerpts do not discuss vial type for injection formulations.
Digoxin injection formulations can vary as brand or generic supply.
Provided label excerpts do not discuss injection formulation availability by brand/generic supply.
Contradictions
Important Omissions
Digoxin toxicity symptom characterization is incomplete/under-represented in the claim set: confusion/CNS manifestations were treated as absent, but the label provides a specific toxicity symptom list (including visual changes and multiple arrhythmia/block descriptions).
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Moderate
Unsupported administration and atrial flutter-related indication claims plus an unsupported/possibly misrepresented toxicity-symptom item (confusion) may affect safe recognition of toxicity and indication scope.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Medium |
Recommendation
Partially Aligned
Primary Issue
Several claims are unsupported by the provided label excerpts, including atrial flutter indications/rate control and multiple digoxin injection formulation/administration details; additionally, a potentially material toxicity-symptom mapping issue exists (confusion).
Suggested Improvement
Restrict claims to label-supported indications (heart failure in adults; control of ventricular response in chronic atrial fibrillation) and label-listed toxicity symptoms/monitoring; remove or qualify unsupported assertions about atrial flutter and injection product/formulation variability not present in the provided prescribing information.