Stroke patients should get a clot-busting Genentech drug, even if it's administered a little later than originally advised. A new study shows that Activase--a.k.a. tissue plasminogen activator, or TPA--can be safely given a full four and a half hours after an ischemic stroke. The drug's current label strongly warns that it should only be administered within three hours afterward. If given in time, Activase can save nerve cells that would otherwise die from lack of blood.
That three-hour time limit stems from the risk that Activase might cause bleeding inside the brain. Doctors had worried that the drug's bleeding risk increased if given later; perhaps that's why only 5 percent of ischemic stroke patients actually receive the treatment. But researchers found that patients who received Activase treatment within four and a half hours survived with little impairment from their strokes, compared with 45 percent of patients given placebo.
Genentech said it's too early to say whether the company would ask the FDA to change Activase's labeling to reflect the new findings. But a doctor with the VA in San Diego who was involved in a previous study of the drug said that "this removes any shred of doubt in anyone's mind that intravenous TPA is safe and effective."