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Writer's pictureMohammed A Rashad

Epimax Ointment and Epimax Paraffin-Free Ointment: Reports of Ocular Surface Toxicity and Ocular Chemical Injury

Updated: Aug 21

Epimax Ointment and Epimax Paraffin-Free Ointment by TMMT

Have you ever considered that a simple skincare routine could lead to unexpected eye injuries? Recent reports have highlighted a concerning trend: Epimax Ointment and Epimax Paraffin-Free Ointment, popular eczema and dry skin treatments, have been linked to serious ocular surface toxicity and chemical injuries when used on the face. This revelation has sent ripples through the dermatology and ophthalmology communities, prompting urgent safety advisories and updated usage guidelines.


Think of applying a trusted emollient to soothe your skin, only to experience pain, redness, and blurred vision shortly after. This alarming scenario has become a reality for several patients, leading to a deeper investigation into the safety of these products. In this blog post, we delve into the specifics of these reports, providing crucial advice for both healthcare professionals and patients to prevent such adverse reactions. 


Let’s uncover the essential information you need to ensure the safe use of Epimax Ointment and Epimax Paraffin-Free Ointment.


Key Takeaways


 

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Background Report


Product Information

Epimax Ointment and Epimax Paraffin-Free Ointment are emollients used to treat various skin conditions. These products are regulated as medical devices, although some emollients are regulated as medicines. The distinction is important for understanding the regulatory framework and reporting mechanisms.


Initial Reports and Manufacturer’s Response

In January 2023, Aspire Pharma issued a Field Safety Notice following a cluster of reports in Scotland. These reports highlighted novel ocular surface toxicity in 37 patients, with symptoms such as reduced visual acuity and photophobia. Most patients experienced significant symptom resolution by their first follow-up appointment, averaging 7.3 days.


In response, Aspire Pharma updated the product labelling to include advice on what to do if the product comes into contact with the eyes and emphasized that the ointments should not be used as a soap substitute on the face.


Continued Reports and Further Actions

Despite these measures, further reports of similar incidents across the UK led to another Field Safety Notice in June 2024. This notice reiterated the importance of restricting the use of these products to the body, washing hands after use, and avoiding contact with the eyes. Updated product labelling was provided to reinforce these warnings.


Advice for Healthcare Professionals


Avoid Prescribing for Facial Use

Healthcare professionals must exercise caution when prescribing Epimax Ointment and Epimax Paraffin-Free Ointment. These products should not be used on the face due to the risk of ocular surface toxicity and chemical injury. Instead, they are intended for use on the body to treat conditions such as eczema, psoriasis, and dry skin.


Recognise Symptoms of Ocular Toxicity

If Epimax Ointment or Epimax Paraffin-Free Ointment comes into contact with the eyes, patients may present with a range of symptoms, including:


  • Pain

  • Swelling

  • Redness

  • Watering of eyes

  • Sensitivity to light

  • Blurred vision

  • Burning sensation

  • Grittiness


Treatment of Symptoms

In cases where these symptoms occur, discontinuation of the product around the eyes is crucial. Treatment options may include:


  • Topical lubricants: To soothe and hydrate the eyes

  • Topical antibiotics: To prevent or treat any secondary infections

  • Topical steroids: To reduce inflammation and discomfort


Follow Manufacturer’s Safety Notices

Healthcare professionals should adhere to the advice provided in the manufacturer’s Field Safety Notice. This includes updated product labelling and usage guidelines to prevent ocular injuries.


Report Adverse Reactions

It is essential to report any suspected adverse reactions associated with Epimax Ointment or Epimax Paraffin-Free Ointment. Healthcare professionals should use local and national reporting systems to ensure that these incidents are documented and addressed.


Advice for Patients


Do Not Use on Face

Patients should be explicitly advised not to use Epimax Ointment or Epimax Paraffin-Free Ointment on their face. These products have been reported to cause serious symptoms if they come into contact with the eyes.


Wash Hands Thoroughly

After applying these ointments, it is crucial to wash hands thoroughly to avoid accidental contact with the eyes. This simple step can significantly reduce the risk of ocular injuries.


Seek Medical Advice if Contact Occurs

If the product accidentally gets into the eyes, patients should rinse their eyes well with water and seek medical advice immediately. Prompt action can help mitigate the severity of symptoms and prevent further complications.


Reporting Suspected Reactions


For Patients and Caregivers

Patients and caregivers are encouraged to report any suspected adverse reactions associated with Epimax Ointment or Epimax Paraffin-Free Ointment through the Yellow Card scheme, a vital tool for monitoring the safety of medical products.


For Healthcare Professionals

Healthcare professionals should report incidents involving medical devices through the appropriate channels in their region:


  • England and Wales: Report to the Yellow Card scheme or via the Yellow Card app.

  • Scotland: Report to the Incident Reporting & Investigation Centre (IRIC) and the local incident recording system.

  • Northern Ireland: Report to the Northern Ireland Adverse Incident Centre and the local incident recording system.


When reporting, it is essential to provide detailed information, including:


  • Batch numbers

  • Medical history

  • Onset timing

  • Treatment dates

  • Product brand name


 

Enhance your clinical services with our Clinical Pharmacists for your PCN, GP Practice, or Federation.


 

Conclusion

The reports of ocular surface toxicity and ocular chemical injury associated with Epimax Ointment and Epimax Paraffin-Free Ointment underscore the importance of adhering to safety guidelines. Healthcare professionals must ensure these products are not used on the face and educate patients on the proper use and potential risks. 


By following the advice provided and reporting any adverse reactions, we can help mitigate these risks and ensure the safe use of these emollients.


Partnering with The Medicines Management Team can reduce the ever-increasing strains within primary care, ensuring that your patients receive the highest standard of care. Contact us today to learn how we can support your practice in achieving optimal medicine management.


FAQs



Is Epimax Ointment Paraffin-Free?

No, Epimax Ointment contains paraffin. However, there is a specific variant called Epimax Paraffin-Free Ointment for those who prefer or require a paraffin-free option.

What is Epimax Ointment Used For?

What Cream is Paraffin-Free?

Which Epimax Cream is Best?


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