The Anesthesia Patient Safety Foundation and the Institute for Safe Medication Practices issued a joint warning urging hospitals to eliminate vials and ampules of tranexamic acid from perioperative settings due to the risk of fatal wrong-drug, wrong-route errors, according to a news release shared with Becker’s.
The warning follows multiple reports of mix-ups in high-risk areas such as the operating room, labor and delivery, and emergency departments, where intravenous tranexamic acid has been mistakenly administered intrathecally instead of local anesthetics such as bupivacaine or ropivacaine, a “never event” with a mortality rate of up to 50%, according to a Dec. 3 news release. Survivors may experience permanent neurological harm.
In response, the FDA added a boxed warning to the drug’s label, clarified that tranexamic acid is contraindicated for neuraxial injection and updated administration instructions to emphasize intravenous use only.
The groups urged hospitals to stock only premixed, ready-to-administer IV bags (1,000 milligrams per 100 milliliters), remove vials from operating rooms, and implement barcode scanning, standardized workflows and NRFit-brand connectors to prevent wrong-route administration.
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