Drugs

FDA Strengthens Tranexamic Acid Warning

FDA says it is requiring labeling changes to tranexamic acid injection products to strengthen the Warning that it should only be administered intravenously and is not indicated for intrathecal or epidural use. An agency statement says the labeling changes follow FDA’s identification and evaluation of medication error cases of inadvertent neuraxial administration of tranexamic acid.

In these cases, the notice says, tranexamic acid was erroneously administered neuraxially instead of the intended local anesthetic, which resulted in serious patient outcomes, including prolonged hospitalization and death.

“Medical practice-level and facility-level human factors (e.g., storing tranexamic acid injection close to local anesthetics and failing to verify the product before administration) contributed to the medication errors,” FDA says.

The agency is requiring these changes to the prescribing information:

add a Boxed Warning on the risk of medication errors involving inadvertent neuraxial administration of tranexamic acid injection;
add a statement indicating that tranexamic acid injection is contraindicated as a neuraxial injection; and
update the Dosage and Administration section to clarify that tranexamic acid injection is only to be administered intravenously and to provide instructions for preparing and administering the diluted solution.

FDA says it is also recommending that the container labels for tranexamic acid injection prominently display the product name and intravenous route of administration.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome