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FDA Investigates Leukemia Drug Iclusig Based on Rising Reports of Critical Blood Clots

Oct 11, 2013

The U.S. Food and Drug Administration (FDA) is investigating the leukemia chemotherapy drug Iclusig (ponatinib) due to the increasing frequency of reports of patients taking the drug having critical blood clots and severe narrowing of arteries and veins.

The FDA is informing health care professionals to decide for each individual patient whether the benefits of Iclusig treatment exceed its risks. The agency also informs patients taking Iclusig to seek immediate medical attention if they experience symptoms suggesting a heart attack; these include 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.

Iclusig 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.

When Iclusig was approved in December 2012, the drug 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 patients, and blood clots in the veins occurred in 3% percent of patients.

However, in the most recent clinical trial data submitted to the FDA by the manufacturer, at least 20% of participants developed blood clots or narrowing blood vessels.

Data from clinical trials and post-market adverse event reports show that serious adverse events have occurred in patients treated with Iclusig, 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 and loss of blood flow to the extremities, resulting in tissue death that requires amputation. Newly identified serious adverse reactions have also been reported involving the eyes, including decreased vision and clots in the eye’s blood vessels. These adverse events were seen in all age groups treated and in those with and without cardiovascular risk factors.

The FDA’s investigation is ongoing and the agency says it is working to further evaluate these adverse events. It will notify the public when more information becomes available.

Healthcare professionals and patients are urged to report Iclusig side effects to the FDA’s MedWatch program via 1-800-332-1088 (phone), 1-800-FDA-0178 (fax) and at MedWatch Online.

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