Introduction of New Warning to Durogesic® (fentanyl) Transdermal System and Fentanyl Injection 0.1mg/2ml (fentanyl citrate): Serotonin syndrome may occur under co-administration with serotonergic drugs

Janssen, a division of Johnson & Johnson Pte Ltd, would like to alert healthcare professionals to the possibility of serotonin syndrome, a potentially life-threatening condition, when serotonergic drugs are administered concomitantly with the Company’s fentanyl-containing products, including Durogesic® Transdermal System and Fentanyl Injection 0.1mg/2ml. Based on the results and conclusions of the Company’s review, caution is advised when these products are co-administered with drugs that affect serotonergic neurotransmitter systems. Serotonin syndrome is not an adverse drug reaction associated with the use of Durogesic® or Fentanyl Injection alone, but may occur with the concomitant use of drugs such as Selective Serotonin Re-Uptake Inhibitors (SSRIs), Serotonin Norepinephrine Re-Uptake Inhibitors (SNRIs) and  Monoamine Oxidase Inhibitors (MAOIs). If serotonin syndrome is suspected, treatment with Durogesic® or Fentanyl Injection should be discontinued. Updates to the Singapore package insert of these products have been made to include a warning regarding this safety concern. Please refer to the letters for more information. Published: 25 Sep 2013

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