Other safety alerts
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| The United States: FDA alerts healthcare professionals about the risk of medication errors with tranexamic acid injection resulting in inadvertent intrathecal (spinal) injection: Update |
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The United States Food and Drug Administration (FDA) continues to receive reports of tranexamic acid injection being erroneously administered intrathecally instead of the intended intrathecal (spinal) anesthetic (e.g., bupivacaine injection) for neuraxial anesthesia.
These medication errors have resulted in severe outcomes, including death, disability, and prolonged hospitalization. FDA is conducting a safety evaluation and is investigating the issue. After the evaluation is complete, FDA will communicate any findings or additional actions that will help mitigate these medication errors.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-healthcare-professionals-about-risk-medication-errors-tranexamic-acid-injection-resulting
In Hong Kong, there are 7 registered pharmaceutical products which are tranexamic acid injectables. All products are prescription-only medicines. 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, and was posted on the Drug Office website on 4 Dec 2020. As the safety evaluation is ongoing, the DH will remain vigilant on its conclusion and any safety update of the drug issued by other overseas drug regulatory authorities for consideration of any actions deemed necessary.
Ends/Tuesday, Feb 11, 2025
Issued at HKT 15:00
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