The Food and Drug Administration cleared the way Tuesday for stroke victims to take the first drug that could protect their brains from permanent injury - but only if they get to the emergency room fast.
The clot-dissolving drug tPA, sold by Genentech Inc. under the brand name Activase, is widely used to treat heart attacks. Some stroke specialists already were giving it to their patients as well.
The new FDA approval means Genentech can advertise tPA to emergency rooms, rural doctors, even patients, educating them to recognize the earliest signs of ischemic strokes and get help within a three-hour window when tPA can work.
But improper tPA use can kill, so doctors must use it very carefully and on only some patients, the FDA warned.
Treatment that begins later than three hours after a stroke’s onset can trigger dangerous bleeding in the brain.
And some strokes are caused by this hemorrhaging to begin with, so doctors must rule that out with a brain scan before administering tPA, the FDA said.
Some 500,000 Americans suffer strokes every year. They are the leading cause of adult disability and the nation’s No. 3 killer, claiming about 150,000 lives. Until now, doctors, powerless to stop the damage, focused instead on rehabilitating patients.