CYKLOKAPRON (Tranexamic acid) intravenous injection– Risk of serious including fatal adverse reactions due to inadvertent intrathecal administration

A Dear Healthcare Professional Letter has been issued by Pfizer Private Limited to remind healthcare professionals that tranexamic acid injection is authorised for intravenous use only. Serious, including fatal, adverse reactions have been reported following inadvertent intrathecal administration, primarily due to mix-ups with injectable local anaesthetics. Reported adverse reactions include severe back and limb pain, myoclonus, generalised seizures, cardiac arrhythmias, prolonged hospitalisation and death. Pfizer will be updating the product information to strengthen the warnings that tranexamic acid injections should only be administered intravenously. Healthcare professionals are advised to exercise extreme caution when storing, handling and administering tranexamic acid injectables to ensure the correct route of administration. Please refer to the letter for details.

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 ↗ (opens in new tab) 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.