The FDA is requiring updated labeling for tranexamic acid injection to emphasize the risk of serious harm, including death, if administered incorrectly via spinal injection.
Tranexamic acid injection is indicated for short-term use — two to eight days — in patients with hemophilia to reduce or prevent hemorrhage during and after tooth extraction. It is supplied in single-dose ampules and vials containing 1,000 milligrams in 10 milliliters, and in sodium chloride injection bags with 1,000 milligrams in 100 milliliters.
The agency is mandating a boxed warning, a contraindication for neuraxial (spinal and epidural) use, and revised dosage instructions specifying that the drug must be administered intravenously, according to an Oct. 21 news release. The FDA took action after reviewing cases in which tranexamic acid was mistakenly administered intrathecally or epidurally instead of local anesthetics such as bupivacaine or lidocaine. These errors resulted in prolonged hospitalizations and deaths.
The labeling changes also include recommendations for more prominent container labeling and additional administration safeguards, such as barcode scanning and separate storage from anesthetics. The FDA outlined additional risk-reduction strategies for healthcare professionals and facilities to prevent further medication errors.
