The Food and Drug Administration (FDA) has announced it will require changes to the prescribing labels for tranexamic acid injections. This decision follows reports of medication errors where the drug was administered either intrathecally or as an epidural injection, instead of intravenously.
Tranexamic acid injection is approved for short-term use to reduce or prevent bleeding in patients with hemophilia. The FDA emphasized that it should only be given intravenously.
The new labeling changes include a boxed warning highlighting the risks associated with neuraxial administration of tranexamic acid injection. The updated label will also state that the medication should not be administered neuraxially and will provide revised instructions in the dosage and administration section regarding preparation and delivery of the diluted solution.
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