Other safety alerts
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| Singapore: CYKLOKAPRON (Tranexamic acid) intravenous injection– Risk of serious including fatal adverse reactions due to inadvertent intrathecal administration |
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Health Science Authority (HSA) announces that 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 following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/cyklokapron-(tranexamic-acid)-intravenous-injection--risk-of-serious-including-fatal-adverse-reactions-due-to-inadvertent-intrathecal-administration
In Hong Kong, there are 7 registered pharmaceutical products which are tranexamic acid injectables. All products are prescription-only medicines. Tranexamic acid is used in the treatment and prophylaxis of haemorrhage associated with excessive fibrinolysis. It is also used in the prophylaxis of hereditary angioedema. So far, with regard to tranexamic acid, the Department of Health (DH) has received 6 cases of adverse drug reaction, but these cases were not related to medication errors. Related news was previously issued by FDA & EMA, and was posted on the Drug Office website on 4 Dec 2020, 11 Feb 2025, 22 Oct 2025 and 1 Nov 2025. The current product inserts of the locally registered tranexamic acid injectables have listed that the route of administration is for intravenous or intramuscular only. The precautions on the risk of inadvertent neuraxial administration of tranexamic acid injection is also documented in overseas reputable drug references such as “American Hospital Formulary Service Drug Information”. The DH will remain vigilant on any safety update of the drug issued by other overseas drug regulatory authorities.
Ends/ Saturday, January 17, 2026
Issued at HKT 12:15
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