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FDA Investigates Serious Adverse Events Linked to Leukemia Drug Ponatinib (Iclusig)

Treatment may cause blood clots and narrowing of blood vessels (October 11)

The FDA is investigating an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of arteries and veins in patients taking the leukemia chemotherapy drug ponatinib (Iclusig, Ariad Pharmaceuticals).

Patients taking ponatinib should seek immediate medical attention if they experience symptoms suggesting a heart attack, such as chest pain or pressure; pain in their arms, back, neck, or jaw; or shortness of breath, or if they experience symptoms of a stroke, such as numbness or weakness on one side of the body, trouble talking, severe headache, or dizziness.

Ponatinib is a prescription medicine used to treat adults diagnosed with chronic-phase, accelerated-phase or blast-phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) who are no longer benefiting from previous treatment or who did not tolerate other treatment.

At the time the drug was approved, in December 2012, its label contained information about the risks of blood clots in the “Boxed Warning” and “Warnings and Precautions” sections. In clinical trials conducted before approval, serious arterial blood clots occurred in 8% of ponatinib-treated patients, and blood clots in the veins occurred in 3% of patients. In the most recent clinical trial data submitted by the manufacturer to the FDA, at least 20% of all participants treated with ponatinib have developed blood clots or narrowing of blood vessels.

Data from clinical trials and postmarketing adverse event (AE) reports show that serious AEs have occurred in patients treated with ponatinib, 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.

Other problems occurring with the drug’s use include congestive heart failure (CHF) and the loss of blood flow to extremities, resulting in tissue death requiring amputation. Newly identified serious AEs have also been reported involving the eyes, including decreased vision and clots in blood vessels of the eye.

Source: FDA; October 11, 2013.

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