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.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.