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Friday, November 01, 2013
FDA Asks Ariad to Halt Sale of Leukemia Drug Iclusig
The FDA has asked Ariad Pharmaceuticals to suspend marketing and sales of Iclusig (ponatinib), a chemotherapy agent used to treat leukemia, pending further investigation of reports of a link between the drug and increased risk of "life-threatening blood clots and severe narrowing of blood vessels".
Patients currently taking Iclusig who are not responding to the drug should immediately discontinue treatment.
Patients who are currently taking Iclusig, who are responding to the drug, and whose healthcare professionals determine that the potential benefits outweigh the risks should be treated under a single-patient Investigational New Drug (IND) application or expanded access registry program while FDA's safety investigation continues.
Healthcare professionals should not start treating new patients with Iclusig unless no other treatment options are available and all other available therapies have failed.