Overview

Xylometazoline is used for the symptomatic relief of nasal congestion in colds and to aid drainage of secretions in sinus conditions. It is also indicated as an adjuvant to decongest the nasopharyngeal mucosa in patients with otitis media¹.

Background of Safety Issue

The National Pharmaceutical Regulatory Agency (NPRA) received information from the Pharmacovigilance Risk Assessment Committee (PRAC), European Medicine Agency (EMA), on the risk of serious ventricular arrhythmia in patients with long QT syndrome associated with xylometazoline-containing products². This review was initiated by PRAC following a case where a patient who self-administered xylometazoline intranasally later experienced cardiac arrest and ventricular fibrillation compatible with long QT syndrome.

There is a known association between xylometazoline and the adverse events of cardiovascular disease, such as increased heart rate and irregular heart rate¹. The package insert for xylometazoline products (including in Malaysia) already contains a warning to healthcare professionals to use xylometazoline with caution in patients with underlying cardiovascular disease¹.

In Malaysia, there are currently four (4) registered products containing xylometazoline³. The package insert of the xylometazoline innovator product has been updated with a warning and precaution on the use of xylometazoline in patients with underlying cardiovascular diseases, and the cardiovascular adverse event such as irregular heart rate (classified as very rare). At the time of this publication, information on the risk of serious ventricular arrhythmia in patients with long QT syndrome has not been updated in the local package insert as NPRA continues to review this safety issue.

Adverse Drug Reaction Reports⁴

NPRA has not received any adverse drug reaction (ADR) reports related to the use of xylometazoline-containing products.

Advice for Healthcare Professionals

• Please be alert on the known association of xylometazoline with cardiovascular adverse events, especially on the risk of serious ventricular arrhythmia in patients with long QT syndrome.
• Educate patients and/or their caregivers on the signs and symptoms of potential cardiovascular events. Advise them to seek immediate medical attention if they experience any cardiovascular events.
• All healthcare professionals are encouraged to report any adverse events suspected with xylometazoline use to NPRA.

References:

1. Otrivin 0.05% Nasal Drops, 0.1% Nasal Drops, 0.1% Nasal Spray and Metered Dose Nasal Spray 0.05% w/v Malaysian package insert. [Last revision date: April 2017]
2. EMA (2018). PRAC recommendations on signals adopted at the 29-31 October 2018 PRAC meeting. Xylometazoline – Serious ventricular arrhythmia in patients with long QT syndrome. EMA/PRAC/7581522018.
3. The NPRA QUEST 3+ database [Accessed: January 2019]
4. The Malaysian Adverse Drug Reaction database, NPRA [Accessed: January 2019]

DISCLAIMER
This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication.