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article imageChemo drug linked to blood clots in arteries and veins

By Tim Sandle     Oct 11, 2013 in Health
The U.S. FDA is investigating an increasing frequency of serious and life-threatening blood clots and severe narrowing of blood vessels (arteries and veins) of patients taking the chemotherapy drug Iclusig.
Iclusig is alternately known as ponatinib. Iclusig is a prescription medicine used to treat adults diagnosed with myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia, who are no longer benefiting from previous treatment or who did not tolerate other treatment.
The U.S. Food and Drug Administration (FDA) has raised concerns because data from clinical trials and post market adverse event reports show that serious adverse events have occurred in patients treated with Iclusig, including heart attacks resulting in death, worsening coronary artery disease, stroke, narrowing of large arteries of the brain, severe narrowing of blood vessels in the extremities, and the need for urgent surgical procedures to restore blood flow.
EMPR notes that at the time of Iclusig’s approval in December 2012, the drug label contained information about the risks of blood clots. In clinical trials conducted before approval, serious arterial blood clots occurred in 8 percent of Iclusig-treated patients, and blood clots in the veins occurred in 3 percent of Iclusig-treated patients.
However, in the most recent clinical trial data submitted by the manufacturer to FDA, at least 20 percent of all participants treated with Iclusig have developed blood clots or narrowing of blood vessels.
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