Discontinuation of paediatric injectable digoxin: A loss for optimal drug therapy in children

Area of Science:

• Pharmacology
• Pediatric Medicine
• Drug Formulations

Background:

• The 50 μg/mL injectable digoxin formulation for pediatric use was discontinued in Canada in early 2015.
• The only available injectable formulation is now five times more concentrated (250 μg/mL).

Purpose of the Study:

• To highlight the challenges and risks associated with using a more concentrated injectable digoxin formulation in pediatric patients, particularly low-weight infants.
• To emphasize the need for a safe and efficient injectable digoxin formulation for intravenous administration in all pediatric patients.

Main Methods:

• This study is a review of the implications of the digoxin formulation change.
• It discusses the challenges in accurately measuring small volumes of the concentrated formulation for low-weight infants.
• It addresses the narrow therapeutic index of digoxin and the risks of inaccurate dosing.

Main Results:

• The increased concentration of injectable digoxin poses significant challenges for precise dosing in low-weight infants.
• Accurate administration is difficult, increasing the risk of adverse events due to digoxin's narrow therapeutic index.
• Alternative methods for managing this situation are less efficient and safe compared to the discontinued formulation.

Conclusions:

• The discontinuation of the lower-concentration injectable digoxin formulation presents a critical issue for Canadian pediatric hospitals.
• Ensuring the availability of the safest and most effective injectable digoxin formulation is paramount for pediatric patient care, irrespective of age or weight.
• Further consideration and potential solutions are needed to address the safe administration of intravenous digoxin in infants.