Sale of Leukemia Drug Halted Due to Substantial Number of Blood Clots and Heart Disease
Posted Nov 01 2013 2:56am
The drug was only approved a year ago so the numbers of people with clots and other issues arose quickly. A few people died after only taking the drug for a couple of weeks and many had no risk factors with heart disease. The side effects were much worse than imagined and the FDA will research to see if there is in fact any smaller group of individuals that the drug could still help. 8 percent is a pretty high number for developing blood clots and it was recently updated by the FDA to 48 percent with a group of patients studied over a year.
The treatment was not cheap either at around $100k a year and it was meant to be given to patients with a certain genetic mutation that made their cancer resistant to other drugs. BD
Sales of a promising leukemia drug, Iclusig, are being suspended because of “the risk of life-threatening blood clots and severe narrowing of blood vessels,” the Food and Drug Administration said on Thursday.
The drug, also known as ponatinib, has been linked to severe and sometimes fatal heart attacks and strokes, blindness and loss of blood flow in the extremities serious enough to require amputation. In some cases, the problems or deaths occurred as soon as two weeks after patients began taking the drug, the agency said in a statement . It also said some of the people affected had no risk factors for heart disease, and some were in their 20s.
Iclusig was approved less than a year ago to treat chronic myeloid leukemia. The risk of blood clots was known, and the label carried a warning. But over time, the problems turned out to be much worse than they appeared in the studies performed before the drug was approved. In those studies, 8 percent of people taking the drug had serious blood clots in their arteries, and 3 percent had blood clots in veins.