The American Heart Association (AHA) released an advisory that a “clot-busting” drug can be effective for an extra 90 minutes longer than what the FDA has approved the drug for. The drug, called recombinant-tissue plasminogen activator, or rt-PA, is one that can be administered to stroke patients when they enter the hospital and will immediately dissolve clots, possibility preserving patients’ ability to function. The FDA has for the last ten years has set a limit on allowing the drug to only be used within 3 hours of a patient suffering a stroke. The AHA advisory, however, shows that the drug can still be effective on patients if it is administered with 4.5 hours of a patient suffering a stroke.

Rt-PA works almost instantly dissolving clots, which account for more than 85% of strokes. The drug is in effective for the 15% of strokes caused by a burst blood vessel in the brain. Once a stroke patient comes to the emergency room, it can take up to 45 minutes to determine what the cause of the stroke is, often times brining the patient out of the FDA-approved 3 hour window for the drug. A further challenge is getting people to the emergency room on time. Fewer than 25% of people recognize their stroke symptoms soon enough to even get to the hospital in time to be administered the drug.

Using the drug according to the AHA advisory is an off-label use of rt-PA. It is legal to use drugs for an off-label use after the drug has been approved by the FDA, but it is much more risky. This advisory gives doctors that administer the drug past the 3 hour time limit support. The advisory also states that people that aren’t suited for use of the drug after 3 hours are those who are older than 80, those who are on blood thinners for a cardiovascular condition, and those who have diabetes or previous strokes. Barnes-Jewish Hospital has been administering the drug for the extra 90 minute window since the beginning of the year.

For more information, see the St. Louis Post-Dispatch Article at:
http://www.stltoday.com/stltoday/lifestyle/stories.nsf/healthfitness/story/958DD75F122A2F3E862575DF00742BEF?OpenDocument

Labels: American Heart Association, Barnes-Jewish, clot-buster, FDA, rt-PA, stroke