Ponatinib Scrutinized Over Blood-Clot Risk


October 11, 2013

The US Food and Drug Administration (FDA) is investigating a rise in reports of life-threatening blood clots and blood-vessel narrowing in patients taking ponatinib (Iclusig, ARIAD Pharmaceuticals, Inc.) to treat leukemia, the agency announced today.

Ponatinib is indicated for adults with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) who do not tolerate or no longer benefit from other therapies such as imatinib (Gleevec, Novartis Pharmaceuticals Corporation).

When the FDA approved ponatinib just 10 months ago, it required the label to feature a boxed warning about the risk for blood clots. Clinical trials prior to approval reported serious arterial blood clots in 8% of patients treated with the drug, and venous blood clots in 3%. Since then, the manufacturer has submitted additional clinical trial data to the FDA showing that at least 20% of patients given ponatinib have experienced blood clots or narrowed blood vessels.

According to these data as well as postmarket adverse event reports submitted to the FDA, patients receiving the drug have had fatal heart attacks, worsening coronary artery disease, stroke, narrowing of large brain arteries, severe narrowing of blood vessels in the arms and legs, and "the need for urgent surgical procedures to restore blood flow."

The agency is advising clinicians to consider for each patient whether the risks of ponatinib will likely outweigh the benefits. Patients should be instructed to seek immediate medical care if they experience any symptoms suggesting a heart attack or stroke.

"FDA is actively working to further evaluate these adverse events and will notify the public when more information is available," the agency stated in a news release.

More information about today's announcement is available on the FDA Web site.

To report problems with ponatinib, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852- 9787.


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