FDA adds boxed warning to drug used to stop bleeding


The following is from MedPage Today.


The FDA is issuing a new boxed warning for tranexamic acid (TXA) injection following serious medication errors—some fatal.

The agency says cases have been reported in which TXA was mistakenly administered into the spine (neuraxially) instead of being given intravenously. These errors resulted in seizures, cardiac arrhythmias, extended hospitalizations, and deaths.

The boxed warning now clarifies that the drug—sold under the brand name Cyklokapron—is for IV use only, and is contraindicated for spinal or epidural injection.

FDA is also recommending label changes and safety steps for hospitals to prevent mix-ups with local anesthetics often used near TXA, such as bupivacaine or lidocaine.

TXA is used to prevent excessive bleeding, especially in hemophilia patients, and is common in surgical settings. It has long been available in generic form.

For more information, read the full article here.


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2 thoughts on “FDA adds boxed warning to drug used to stop bleeding”

  1. Cheryl. The State of California in the earl y in 1990s in the Sacramento City Unified School District violated Informed Consent by changing from Liquid Flouride semester One to a Flouride Pill second semester. As a 2nd grade teacher at A.M. Winn Elementary, and extrmely niave. When the school nurse came in 2nd semester and gave me the Flouride pill bottle,I threw the pills in the pill bottle container in the trash after school, same day. It did not occur to me it would be refilled. I was already in hot water because a former principal 15 yr my senior was polite, but politely rejected, ..and I also called out a peer for making a racial slur in after school budget meeting. This school the Principal was a malicious personality. I tild the nurse ,I lost them. The attorney said not to tell the truth. The District brought in Counsel, overligated, and were now bringing in some LA attorneys. The SCTA union couldn’t understand why it was so “visceral.” I eventually represented myself, they caved at prelim. I got back pay withheld if I resigned. I had even sold my car and making flour noodles. A prior study exists. It was my best class. It broke me emotionally. I texted you about my sister. My Hipaa Rights unter 45 CFRs are worthless. I am under threat. If the DOJ continues to exclude Senators in FISA to prevent oversight medical research will ” “adjust” equipment, records, without exposure. This school was a Title 7 school. Did they do 1041=N. Sac City Unified would not be hard pressed. I think it was State Wide. My garage was ransacked, and the Court pspers missing. My current phone was pickpickoted. This phone is a clone. I know you have experienced privacy breaches also.

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