GovWire

Background

Epimax Ointment and Epimax Paraffin-Free Ointment are emollients, which are used to treat eczema, psoriasis and dry skin conditions. These specific products are regulated as medical devices, although some emollients are regulated as medicines.

The manufacturer, Aspire Pharma, previously issued a warning to users via a Field Safety Notice on 20 January 2023, following a cluster of reports concerning ocular surface toxicity and ocular chemical injury in Scotland. These cases have subsequently been published.^{[footnote 1]}

The case series reported novel ocular surface toxicity in 37 patients, related closely (often less than 1 week) to Epimax initiation. Most patients reported subjectively reduced visual acuity, frequently associated with photophobia. There was significant symptom resolution by first follow up appointment (average 7.3 days).^{[footnote 1]}

In 2023 Aspire Pharma updated the product labelling to include advice on what to do if the product comes into contact with the eyes by accident, and to explain that it can be used as a body wash and not as a soap substitute that might be used on the face and around the eyes.

Following further similar reports across the UK, Aspire Pharma issued another Field Safety Notice on 13 June 2024 to inform patients and healthcare professionals that product information would be updated to restrict use of the product to the body and to not use the product on the face, to wash hands after use and to further emphasise the warnings about avoiding contact with the eyes.

See page 3 of the Field Safety Notice for the most up to date Epimax Ointment product labelling, and page 4 of the Field Safety Notice for the most up to date Epimax Paraffin-Free Ointment product labelling.

Report suspected reactions

Patients and caregivers should report suspected adverse reactions associated with all emollients, including Epimax Ointment or Epimax Paraffin-Free Ointment, to the Yellow Card scheme.

As these specific ointments are classed as medical devices, there are specific reporting arrangements for healthcare professionals to follow in each region of the UK. An emollient which is regulated as a medical device will have a CE or UKCA mark. If it is regulated as a medicine, it will have a product licence (PL) number. See guidance for reporting on adverse reactions on the Yellow Card website.

Healthcare professionals should report incidents involving medical devices:

• in England and Wales to the Yellow Card scheme or via the Yellow Card app
• in Scotland to Incident Reporting & Investigation Centre (IRIC) and their local incident recording system
• in Northern Ireland to the Northern Ireland Adverse Incident Centre and their local incident recording system.

When reporting, please provide as much information as possible, including information about batch numbers, medical history, onset timing, treatment dates, and product brand name.

Article citation: Drug Safety Update volume 17, issue 12: July 2024: 1.

References