The Food and Drug Administration (FDA) has suspended sales of a once-promising leukemia drug because of “the risk of life-threatening blood clots and severe narrowing of blood vessels.”
The drug Iclusig, also known as ponatinib, has been linked to severe and sometimes fatal heart attacks, strokes and loss of blood flow to the extremities, sometimes serious enough to cause amputation. Some problems occurred as soon as two weeks after people began taking the drug, the FDA said. Many of the problems occurred in patients with no history of heart disease and in some patients as young as 20 years old.
Initial studies of Iclusig revealed that the drug carried the risk of blood clots in 12 percent of patients. Over time, however, problems with the drug turned out to be far more serious than the earlier studies indicated. The FDA now reports that 24 percent of patients studied for 1.3 years and 48 percent of patients studied for about 2.7 years suffered “serious adverse vascular events” such as strokes and aneurisms.
A spokesperson for the FDA said that the drug, used to treat chronic myeloid leukemia, is not being permanently shelved. The FDA will work with the drug maker to determine which patients will still benefit from the drug. Individuals suffering from leukemia who are currently taking Iclusig are allowed to continue taking the drug, the FDA said.
Approximately 5000 new cases of chronic myeloid leukemia are diagnosed each year, according to the FDA. Ten percent of those patients succumb to the disease.