Emollients: new information about risk of severe and fatal burns with paraffin-containing and paraffin-free emollients

Warnings about the risk of severe and fatal burns are being extended to all paraffin-based emollients regardless of paraffin concentration. Data suggest there is also a risk for paraffin-free emollients. Advise patients who use these products not to smoke or go near naked flames, and warn about the easy ignition of clothing, bedding, dressings, and other fabric that have dried residue of an emollient product on them.

Advice for healthcare professionals:

  • emollients are an important and effective treatment for chronic dry skin conditions and people should continue to use these products. However, you must ensure patients and their carers understand the fire risk associated with the build-up of residue on clothing and bedding and can take action to minimise the risk
  • when prescribing, recommending, dispensing, selling, or applying emollient products to patients, instruct them not to smoke or go near naked flames because clothing or fabric such as bedding or bandages that have been in contact with an emollient or emollient-treated skin can rapidly ignite
  • there is a fire risk with all paraffin-containing emollients, regardless of paraffin concentration, and it also cannot be excluded with paraffin-free emollients. A similar risk may apply for other products which are applied to the skin over large body areas, or in large volumes for repeated use for more than a few days
  • be aware that washing clothing or fabric at a high temperature may reduce emollient build-up but not totally remove it
  • warnings, including an alert symbol, are being added to packaging to provide a visual reminder to patients and those caring for them about the fire hazard
  • report any fire incidents with emollients or other skin care products to the Yellow Card Scheme

Risk of severe and fatal burns with emollients

The risk of severe and fatal burns with emollients containing more than 50% paraffins was communicated in January 2008 and April 2016 via Drug Safety Update, in addition to the National Patient Safety Agency alert in 2007.

Evaluation of more recently available data showed that products containing less than 50% paraffins have been associated with fatal burns and paraffin-free products also have a fire accelerant effect in tests when emollient residue builds up on fabric and the fabric is ignited.

It is difficult to estimate the true size of the risk based on case reports because of the likely under reporting of such events. We are currently aware of 11 cases (5 Coroner’s Regulation 28 reports to Prevent Future Deaths and 6 others) in which paraffin-based emollients are suspected to have contributed to the speed and intensity of a fire, resulting in fatal burns injury. There are also 50 fire incidents (49 fatal) reported by Fire and Rescue Services across the UK between 2000 and November 2018, in which emollients were known to have been used by the victim or were present at the fire premises. However, in most of these it is not clear what the attributable role of paraffin creams in the deaths would have been, in the presence of multiple risk factors for a fire incident.

Mechanism of the risk

The emollient products are not flammable in, or of themselves. However, they act as an accelerant, increasing the speed of ignition and intensity of the fire when fabric with residue dried on it is ignited.

Review of new evidence

In response to the more recent evidence, MHRA convened an ad hoc Expert Group to advise the Commission on Human Medicines (CHM) on the benefits and risks of these products and the appropriate regulatory action to minimise risk and protect public health.

The CHM advised that, taking into account the very rare risk, the modifiable risk factors, and their important therapeutic role, the benefits of these products outweigh the risk. However, CHM advised that the following was needed to protect public health:

  • outer packaging and product containers should include a warning about the fire hazard, with the advice not to smoke or go near naked flames

  • where available, the Patient Information Leaflet or Instructions for Use and the Summary of Product Characteristics should be updated to include warnings about the risk and how best to minimise it

Additionally, MHRA is setting up a specific stakeholder group to make proposals for measures to promote education and awareness of this risk.

Article citation: Drug Safety Update volume 12, issue 5: December 2018: 3.

Published 18 December 2018