Iclusig Linked to Possibly Fatal Blood Clots

The FDA is investigating increasing reports of serious and life-threatening blood clots and severe narrowing of blood vessels in patients taking Iclusig (ponatinib; Ariad).

Iclusig is a kinase inhibitor indicated for chronic, accelerated, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy, and for Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy.

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In the most recent clinical trial data, at least 20% of patients treated with Iclusig developed blood clots or narrowing of blood vessels. 

Previous clinical trial data showed other adverse events that have occurred in patients, 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.

Healthcare professionals are to consider whether the benefits of Iclusig treatment are likely to exceed the risks of treatment. 

Patients taking Iclusig should be aware of symptoms suggesting a heart attack such as chest pain or pressure, pain in their arms, back, neck or jaw, shortness of breath; or symptoms of a stroke such as numbness or weakness on one side of the body, trouble talking, severe headache or dizziness.

The FDA will notify the public when more information is available.

For more information call (888) 463-6332 or visit the FDA Safety Alerts page.