MAG / The Pharmaceutical Journal
Healthcare professionals have been reminded of the fire risk associated with paraffin-containing skin creams, following a BBC radio programme that highlighted the potential dangers.
An investigation by BBC Radio 5 Live, which was aired on 19 March 2017, claimed that there had been 37 fire deaths in England associated with paraffin-containing skin creams since 2010.
The programme prompted the UK Medicines and Healthcare products Regulatory Agency (MHRA), which regulates medicines and medical devices in the UK, to highlight the advice it has given healthcare professionals about the potential fire risks linked to paraffin-containing skin products.
The MHRA also reiterated that it has requested that manufacturers include appropriate warnings on their products.
A spokesperson for the MHRA says: “For those emollients which are licensed as medicinal products we have asked that they all carry a warning to alert patients, carers and healthcare professionals to the risk from fire.
“We have advised healthcare professionals through articles in our monthly Drug Safety Update publication of these risks on two occasions in 2008 and again in 2016.”
The MHRA says that, following the results of a study by the National Patient Safety Agency in 2007, it wrote to marketing authorisation holders in 2008 requesting that emollients authorised as medicinal products which contained 50% or more of a paraffin base should carry a warning advising of the risk from fire.
However, the MHRA spokesperson acknowledges that “there is no legal requirement for companies to action this”.
“This advice has now been updated and where any emollient is authorised as a medicine the expectation is that the labelling will include the appropriate warning advising of the risk from fire,” they add.
The Proprietary Association of Great Britain (PAGB), the UK trade association representing manufacturers of branded over-the-counter medicines, sought to reassure the public about the safety of paraffin-containing skin creams.
It issued a statement after the BBC Radio investigation aired, pointing out that the fire risks relating to emollients are associated with them being used in “significant amounts” of 100g or more, which would typically take place in a healthcare setting rather than use in the home “by people treating common levels or eczema or other dry skin conditions”.
John Smith, chief executive of the PAGB, says: “We want to reassure people that the normal use of emollients in the home is considered appropriately safe provided the products are used in accordance with the on-pack instructions and accompanying patient information leaflet.
“Manufacturers of emollients are not at present required by regulation or statute to include fire safety warnings on packaging.”
He adds: “In the light of this investigation, [the] PAGB is looking to explore this issue further with the member companies and relevant bodies to see if in future, safety warnings should be added to on-pack labelling for all paraffin-based emollients as standard practice across the industry, a step which some manufacturers have already taken.”
