In December 2018 the Medicines and Healthcare products Regulatory Agency (MHRA) extended the warning of severe or fatal burns to all paraffin-based emollient products regardless of their paraffin content, there is also data to suggest that the risk includes paraffin-free emollients.

A similar risk may apply to products which are applied to the skin over large body areas, or in large volumes for repeated use for more than a few days.

The risk associated with the flammability of paraffin-based emollients was first communicated to Healthcare Professionals in Drug Safety Updates in January 2008 and April 2016. Evaluation of more recently available data shows that products containing less than 50% paraffins have been associated with fatal burns and paraffin-free products have a fire accelerant effect. In tests where the emollient residue built up on fabric and the fabric was ignited the speed of ignition and the intensity of the fire were increased, even though the emollient products are not flammable themselves.

The Commission on Human Medicines (CHM) advises that, although the risk is rare and actions can be taken to minimise the identified risks, the following is 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, including an alert symbol
• where available the Patient Information Leaflet, Instructions for Use and Summary of Product Characteristics should be updated to include warnings about the risk and how to minimise it

Advice to Healthcare Professionals and patients

• Emollients are a key treatment for dry skin conditions and patients should continue to use these products. However patients and carers must understand the fire risk associated with the build-up of residue on clothing and bedding and 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
• Be aware that there is a fire risk with all paraffin-containing emollients, regardless of paraffin concentration, and the risk 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
• report any fire incidents with emollients or other skin care products to the Yellow Card Scheme

The full MHRA alert can be found here.