Safety public assessment reports : MHRA

0.18% saline/4% glucose IV solution: safety risks in children

29 October 2012

0.18% saline/4% glucose solution (hypotonic saline) is given to patients intravenously (IV) in a hospital to maintain or replace their fluid and salt requirements.

A review of the risks and benefits of hypotonic saline when used in children was recently undertaken by the MHRA and the Commission on Human Medicines (CHM). The review followed the restart of a public inquiry into the deaths of three children in the UK who died from swelling of the brain (cerebral oedema) caused by dangerously low levels of sodium (hyponatraemia) after receiving 0.18% saline/4% glucose solution IV.

Based on the review, the CHM recommended that 0.18% saline/4% glucose IV solution should not be used in children aged 16 years or less, except under expert medical supervision in paediatric specialist settings such as kidney, heart, liver, high-dependency and intensive care units.

The following Public Assessment Report summarises the results of the review, and the conclusions and recommendations for health professionals and patients.

This report presents the evidence that was available when the regulatory decision was made, showing a ‘snapshot’ of the clinical landscape at the time. However, any advice in this report remains current unless it is superseded by a more recent report (where relevant, this is indicated).

Page last modified: 11 February 2016