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Leukemia Drug Iclusig Pulled from Market After FDA Highlights Blood Clot Risks

Filed November 1st, 2013 Laurie

The formerly promising leukemia drug Iclusig has been pulled from the market by the U.S. Food and Drug Administration (FDA); this was because of “the risk of life-threatening blood clots and severe narrowing of blood vessels.”

Iclusig has been linked to severe and sometimes fatal heart attacks and strokes, blindness, and loss of blood flow in the extremities serious enough to warrant amputation. Some of the drug’s severe adverse events can occur within two weeks of starting treatment, the FDA said. Some patients affected were in their twenties and had no other underlying risks for heart disease, according to the New York Times (Times).

Approved only a year ago for the treatment of myeloid leukemia, the risk of blood clots associated with Iclusig was already known and the label carried a warning. Studies performed before the drug’s approval showed that 8 percent of people taking the drug had serious blood clots in their arteries, and 3 percent had blood clots in their veins. According to the FDA’s report, 24 percent of patients studied a median of 1.3 years and 48 percent studied a median of 2.7 years had “serious adverse vascular events” – numbers that FDA spokeswoman Stephanie Yao called “pretty significant.” Yao told the Times that “we can’t let a drug continue to be marketed with that profile.”

About 5,000 new cases of myeloid leukemia are reported in the U.S. each year, resulting in about 600 deaths. Iclusig costs about $100,000 a year, and patients were expected to need it for life. The drug was hailed as part of a revolution that transformed the disease from a death sentence into a chronic disease. Iclusig was intended for patients with a mutation that made their cancer resistant to another drug, Gleevec, and other related drugs, according to the Times.

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