The US Food & Drug Administration says it continues to receive reports of tranexamic acid injection being erroneously administered intrathecally instead of the intended intrathecal (spinal) anaesthetic (e.g, bupivacaine injection) for neuraxial anaesthesia.
These medication errors have resulted in severe outcomes, including death, disability, and prolonged hospitalisation, said the agency, adding that it was conducting a safety evaluation and investigating the issue.
It reminds healthcare professionals that intrathecal administration of tranexamic acid injection may result in serious life-threatening injuries, including seizures, cardiac arrhythmias, paraplegia, permanent neurological injury, and death.
In most of the cases reported to FDA, tranexamic acid injection was erroneously administered instead of the intended intrathecal anaesthetic for neuraxial anesthesia.
Tranexamic acid injection is an anti-fibrinolytic indicated in patients with haemophilia for short-term use (two to eight days) to reduce or prevent haemorrhage, and reduce the need for replacement therapy during and after tooth extraction.
It should be administered by the intravenous route. It is supplied in single-dose ampules and single-dose vials containing 1 000 mg tranexamic acid in 10 mL, and is available as a generic drug product and under the proprietary name, Cyklokapron.
Tranexamic acid injection, bupivacaine injection and other products used in the perioperative setting may have a similar appearance, such as similar vial cap colour or packaging that may contribute to the mix-ups. Other practice-level and facility-level contributing factors – such as storing products with similar appearance close by – may also contribute to these errors.
The FDA is taking action to address these medication errors, which includes revising the tranexamic acid injection container labels and carton labelling to highlight the recommended intravenous route of administration; and strengthening the warnings in the tranexamic acid prescribing information to include the risk of medication errors due to incorrect route of administration.
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