Swissmedic has issued an important safety advisory regarding Tegretol 2% oral suspension, which contains propylene glycol. This announcement highlights updated precautionary measures for administering the medication to newborns. Healthcare professionals working in clinical and regulatory fields should closely review this notice to ensure compliance and patient safety.
What changed?
Tegretol 2% oral suspension, commonly used for epilepsy and other neurological disorders, contains propylene glycol as an excipient. Swissmedic has introduced additional guidance with a focus on its use in newborns, particularly those under 28 days old. The new measures aim to ensure safe use by minimizing the risk of potential adverse effects associated with propylene glycol exposure.
Who is affected?
This advisory is targeted at clinicians, pharmacists, and regulatory teams responsible for prescribing and monitoring Tegretol. Special focus is placed on neonatal care units and practices prescribing the medication to infants. Quality assurance teams may also need to evaluate compliance with updated Swissmedic safety recommendations.
Safety details and clinical considerations
What are the clinical risks for newborns?
Propylene glycol is metabolized differently in newborns compared to adults, with neonates demonstrating reduced enzymatic activity. This can lead to accumulation and increased risk for toxicity, including metabolic acidosis. The precautionary measures outlined by Swissmedic aim to reduce the likelihood of these complications when Tegretol 2% is administered.
Monitoring and dosage guidelines
Swissmedic advises strict adherence to prescribed dosages and careful monitoring of plasma levels after administration of Tegretol 2%. Regular assessment of liver and kidney function should also be conducted to identify early signs of toxicity in newborns.
Are alternatives available?
Healthcare teams should explore alternative formulations and medications that do not contain propylene glycol for patients identified as high-risk. Substitutions should be based on a comprehensive clinical evaluation.
Implications for regulatory compliance
Manufacturers and distribution teams should ensure that labels and patient information leaflets reflect the updated precautions. Regulatory submissions may be required to demonstrate compliance with Swissmedic updates under MDR guidelines.
Q1: Does this apply to all formulations of Tegretol?
A1: No, this advisory specifically concerns Tegretol 2% oral suspension containing propylene glycol.
Q2: How should plasma levels be monitored?
A2: Plasma levels should be regularly checked using laboratory methods recommended in current clinical guidelines.
Q3: Are there restrictions for other age groups?
A3: The advisory primarily focuses on newborns, but clinicians may extend vigilance in case-by-case assessments.
Conclusion
Swissmedic’s advisory underscores the importance of safety measures for Tegretol 2% oral suspension in newborns. Healthcare professionals should update protocols and educate staff on these changes to ensure patient safety.
Disclaimer
This article provides informational guidance based on Swissmedic notifications. It is intended for healthcare professionals and does not constitute legal or medical advice.
Swissmedic announcement
For full information about the Swissmedic announcement, see the link below.
https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/health-professional-communication–hpc-/dhpc-tegretol-propylenglykol.html