Manufacturer Halts Sales of Leukemia Drug Iclusig

Ariad Pharmaceuticals has suspended sales of the chemotherapy drug Iclusig (ponatinib), which is used to treat chronic myeloid leukemia (CML) and some forms of acute lymphocytic leukemia (ALL). The U.S. Food and Drug Administration (FDA) asked Ariad to stop selling the drug while it studied the possible risk of patients developing blood clots. People who are taking Iclusig should talk to their doctors about what to do.

Since the FDA approved Iclusig in December 2012, results from clinical trials have found increased reports of serious blood clots in arteries and veins. While the drug is off the market, the FDA will evaluate the risks and benefits to patients. In the meantime, a program will allow patients who are benefitting from the drug to continue taking it under supervision from their doctor.

In clinical trials conducted before approval, serious blood clots occurred in 8% of patients taking Iclusig, and blood clots in the veins occurred in 3% of patients taking Iclusig. In more recent clinical trial data, at least 20% of patients treated with Iclusig developed blood clots or narrowing of blood vessels.

The FDA recommends that patients on Iclusig 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 symptoms of a stroke such as numbness or weakness on one side of the body, trouble talking, severe headache, or dizziness.

Other serious problems that have been reported and that may require immediate medical attention include sudden loss of vision and pain and loss of circulation in an arm or leg.

The FDA says health care professionals with patients taking Iclusig should weigh the benefits and risks of the drug for each patient.

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