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FDA Investigating Reports of Life-Threatening Blood Clots with Leukemia Drug — Physician’s First Watch

Medical News |
October 15, 2013

FDA Investigating Reports of Life-Threatening Blood Clots with Leukemia Drug

By Kristin J. Kelley

At least 20% of patients taking the chemotherapy drug ponatinib (brand name, Iclusig) in a postapproval trial developed thromboses or narrowing of arteries or veins, the FDA has warned. Congestive heart failure, fatal myocardial infarction, and stroke have also been reported.

The kinase inhibitor is indicated for adults with resistant chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. The FDA recommends that clinicians weigh the benefits of continuing treatment with ponatinib against the risks while the drug is being investigated. A hold has been placed on all new patient enrollment in clinical trials, according to the manufacturer.

Ponatinib was approved in December 2012 with a boxed warning about the blood clot risk.

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