This document communicates safety updates for two different products based on reviewed safety signals.
1. Oxytetracycline HCl, Hydrocortisone Acetate, Polymyxin B Sulfate (Ear/Eye Drops/Ointment)
Safety Signal: Hearing and vestibular disorders (EPITT no 20120)
Updates for Ear Drops/Ear-Eye Drops:
- SmPC Section 4.4 (Warnings):
- A warning states the product is not recommended in cases of eardrum perforation due to the risk of ototoxicity (cochlear or vestibular injury).
- Reports of ear canal blockage by the product, leading to hearing disorders (e.g., hearing loss, deafness, tinnitus) or dizziness, have been added. These issues generally resolve after cleaning the ear canal.
- SmPC Section 4.8 (Undesirable Effects):
- The following reactions have been added with a frequency ‘not known’:
- Ear disorders: Hypoacusis, Deafness, Tinnitus.
- Nervous system disorders: Dizziness.
- The following reactions have been added with a frequency ‘not known’:
- Package Leaflet:
- Patients are warned to tell their doctor if they have a perforated eardrum.
- They are advised to seek medical care for any hearing or balance disorders.
- The possible side effects of hearing disorders and dizziness due to ear canal blockage are listed.
Updates for Ear Ointment:
- Similar warnings against use in cases of eardrum perforation are added to the SmPC and Package Leaflet due to the risk of ototoxicity.
2. Regorafenib (e.g., Stivarga)
Safety Signal: Hyperammonaemia, hyperammonaemic encephalopathy (EPITT no 20147)
Updates:
- SmPC Section 4.4 (Warnings):
- A new warning for hyperammonaemic encephalopathy (including fatal cases) has been added.
- It recommends measuring ammonia levels in patients with unexplained lethargy or mental status changes.
- If confirmed, permanent discontinuation of regorafenib should be considered.
- SmPC Section 4.8 (Undesirable Effects):
- Hyperammonaemic encephalopathy has been added as a reaction with frequency ‘not known’.
- Package Leaflet:
- Patients are advised to contact their doctor immediately if they experience symptoms like severe headache, visual disturbances, seizures, lack of energy, sleepiness, or confusion, as these may be signs of brain toxicity from high ammonia levels.
- These symptoms are listed as possible side effects with frequency ‘not known’.
Purpose
These updates inform healthcare professionals and patients of new or clarified risks, providing essential guidance on contraindications, monitoring, and symptom recognition to ensure the safe use of these medicines.
