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Pharmaceutical excipients with potential to cause adverse effects in paediatric nasal medicines
Ana N Stjepanovic1, Nemanja B Todorovic1, Tamara Z Tesic2
1University of Novi Sad, Faculty of Medicine Novi Sad, Department of Pharmacy, Novi Sad, Serbia.
Insights
Many paediatric nasal medicines contain potentially harmful excipients with known effects (EKE). Labeling deficiencies were found in Serbia, Croatia, and Slovenia, impacting patient safety and healthcare provider information access.
Area of Science:
- Pharmaceutical Sciences
- Paediatric Medicine
- Regulatory Affairs
Background:
- Pharmaceutical excipients can cause adverse reactions, interactions, and contraindications, particularly in paediatric populations.
- Topical nasal medicines require careful consideration of excipient safety for children.
- Excipients with Known Effect (EKE) are substances that may cause adverse effects.
Purpose of the Study:
- To compare the proportion of topical nasal medicines approved for paediatric use.
- To determine the prevalence and labelling of EKE in paediatric topical nasal medicines.
- To assess EKE labelling in Serbia (non-EU) versus Croatia and Slovenia (EU).
Main Methods:
- Post-authorization safety study design.
- Safety evaluation of excipients aligned with European Medicines Agency (EMA) recommendations.
- Comparative analysis of product information across Serbia, Croatia, and Slovenia.
Main Results:
- Over 90% of topical nasal medicines were approved for paediatric use.
- More than half of these paediatric medicines contained EKE.
- Benzalkonium chloride was a common EKE, present in over 50% of products in all studied countries.
- Significant EKE labelling deficiencies were identified in all three countries.
Conclusions:
- A substantial proportion of paediatric topical nasal medicines contain EKE.
- Inadequate labelling of EKE hinders healthcare professionals' ability to counsel patients.
- Revision of paediatric nasal medicine labelling is recommended to improve safety and information access.
Abstract:
Some pharmaceutical excipients may cause adverse reactions, excipient-related interactions and/or contraindications. Due to the unique characteristics of the paediatric population, adverse effects may occur to substances generally thought safe. The proportion of topical nasal medicines approved for paediatric use and the prevalence and labelling of excipients with known effect (EKE) in these products were compared in Serbia as a non-EU country and Croatia and Slovenia as EU countries. The study was designed as a post-authorization safety study and safety of excipients was considered in accordance with recommendations of the European Medicines Agency (EMA). More than 90% of topical nasal medicines registered in the three countries were approved for paediatric use and more than half of these paediatric medicines contained EKE that may cause adverse effects. Benzalkonium chloride was found in 52.38%, 55.81% and 59.09% of these products in Serbia, Croatia and Slovenia, respectively. Propylene glycol, benzyl alcohol, ethanol, methyl paraben, propyl paraben and boric acid were also present in a few analysed preparations. A significant number of EKE labelling deficiencies were detected in all three countries, hindering healthcare professionals' access to information needed for adequate patient counselling. A revision of the nasal paediatric medicines' PLs and SmPCs is recommended.
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