Dear Healthcare Professionals Letter on potential life-threatening adverse reactions after accidental exposure to fentanyl-containing transdermal patches (Durogesic, Fentanil Sandoz, Matrifen, Fentagesic)
17.06.2014
Johnson&Johnson S.E. d.o.o., Sandoz d.o.o., Takeda Pharmaceuticals Croatia d.o.o. and Pliva Hrvatska d.o.o., marketing authorisation holders for fentanyl-containing transdermal patches, have, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter to healthcare professionals about on potential life-threatening adverse reactions after accidental exposure to these medicines.
Summary
- there are still incoming reports to accidental exposure to fentanyl-containing transdermal patches in individuals not using them, especially in children
- In order to prevent potential life-threatening adverse reactions after exposure to fentanyl, healthcare professionals are reminded of the importance of providing clear information to patients and carer regarding the risk of accidental transfer of patches, their accidental swallowing and the need for their adequate disposal:
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- Accidental exposure to transfer of patch - patients and carer should be advised in the case of accidental patch transfer to remove immediately the transferred patch from the skin of the individual not using it
- Accidental swallowing - patients and carer should be advised to carefully select the patch application site and verify the adherence to skin.
- Used patches - patients and carer should be advised to bend the used patches in a way that the adhesive side is laid down on itself and thereafter the patch may be safely disposed.
More information
The accidental exposure to fentanyl-containing transdermal patches is not a new safety issue. However, cases of accidental exposure are continuously appearing, some with a fatal outcome (all happened in children). The EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) recently reviewed the reported cases from the EU and discovered that a reduced visibility of patches could have contributed to this adverse reaction. Therefore, the PRAC has recommended improvement of visibility of fentanyl-containing transdermal patches. The patch visibility is going to be improved next and in the meantime healthcare professionals are reminded with this letter of the importance of providing advice to patients and carer about the safe use and handling of patches.
HALMED has not received any adverse reaction as a result of accidental exposure to fentanyl-transdermal patches. However, HALMED has received one report to fentanyl-containing transdermal patch incorrectly used on the open wound of a 28-months old child, having unfortunately a fatal outcome.
Here you may view the Dear Healthcare Professional Letter.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
