The Medicines and Healthcare Regulatory Agency (MHRA) have been working closely with the Commission on Human Medicines to discuss updates to the Summary of Product Characteristics (SPCs) and Patient Information Leaflets (PILs) of emollient skin creams, amid a recent report that these have caused over 50 fire deaths in the UK.
Emollient face creams are used to treat dry or itchy skin conditions such as eczema, dermatitis, psoriasis and ichthyosis. Emollients are moisturising treatments which can be purchased in various different forms (lotions, ointments, sprays, creams and more) and are sold over the counter in pharmacies.
But what increases the flammability of emollient products? Although the hazard was previously just associated with emollients that contain over 50% paraffins, it has since been discovered that paraffin-free emollients carry equal risk. Fabric becomes more flammable after frequent exposure to these products; the likelihood of such fire deaths increasing for smokers, the elderly and patients using oxygen therapy. As a result, the London Fire Brigade have urged doctors to take extra precaution when prescribing emollients to patients with skin conditions.
In 2006, a patient died at the Doncaster Royal Infirmary when his cigarette reacted with the emollient cream he had been using for the treatment of psoriasis. It was also recorded that 15 people died from such incidents in London alone between 2014 and 2017.
Dr June Raine, Director of the MHRA’s Vigilance and Risk Management of Medicines Division, has stated that patients should not be unnecessarily worried out of using such products, but just be aware of the risks and how to prevent these from occurring. It has been advised that anybody who uses emollients and has any questions or concerns should speak to their GP or a pharmacist.
The MHRA and Commission on Human Medicines have also suggested that SPCs and PILs of emollient products should contain safety warnings, stating the extent of such fire hazards and how users can minimise these (i.e. by not smoking, and knowing that the fire risk can increase as a result of built-up emollient residue on clothing).
For more information about emollients and what they may be prescribed for, please visit the NHS website.
PharSafer has been working with clients and the EMA Regulatory Agencies, advising on what would be appropriate labelling to use for the risk level associated with paraffin-based products.
Paraffin-based products have been used in medicines for well over 50 years, but the risk of flammability has been known to increase if in the presence of a secondary igniter (e.g. bandages or clothing). This has been what has prompted the recent increased safety attention.Share this News item: