Dear Healthcare Professional Letter about the introduction of new warning on possible serotonin syndrome that may occur under co-administration of medicinal products Fentanyl or Durogesic transdermal patches with serotonergic medicines
09.10.2013
The marketing authorisation holder, Johnson & Johnson S.E. d.o.o. is sending a letter, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) to healthcare professionals with the aim to warn about a possible occurrence of serotonin syndrome in cases where serotonergic medicines are administered concomitantly with the marketing authorisation holder’s fentanyl-containing medicinal products Fentanyl and Durogesic Transdermal Patch.
The marketing authorisation holder undertook a review to assess the available evidence for the possibility of serotonin syndrome when serotonergic medicines are administered concomitantly with fentanyl-containing medicinal products that are currently licensed by tha marketing authorisation holder. Based on the results and conclusions of this review, updates to the Summary of Product Characteristic for medicinal products Fentanyl and Durogesic Transdermal Patch have been made to include a warning regarding the potential for serotonin syndrome to occur when these medicinal products are used concurrently with other serotonergic medicines.
Here you may view the Dear Healthcare Professional Letter.
HALMED has not received any adverse reaction report to fentanyl caused by an interaction with serotonergic medicines. HALMED will continue to monitor the safe use of fentanyl and promptly inform the public about any new information.
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.
