An increasing number of serious and life-threatening blood clots and severe narrowing of blood vessels (arteries and veins) in patients taking the leukemia chemotherapy drug Inclusig (Ponatinib) has prompted an investigation by the Food and Drug Administration (FDA).
Data from clinical trials and adverse event reports after the drug was approved in December 2012 show that serious health problems have occurred in patients who were treated with Iclusig, including fatal heart attacks, worsening coronary artery disease, narrowing of the large arteries of the brain, severe narrowing of blood vessels in the extremities, and the need for urgent surgical procedures to restore blood flow.
Inclusig is for patients 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 the drug was approved, there was already a Black Box Warning and additional warnings under the Warnings and Precautions sections of the safety label of the blood clot risk.
Clinical trials before the drug’s approval showed that serious arterial blood clots occurred in eight percent of Iclusig-treated patients, and blood clots in the veins occurred in three percent of Iclusig-treated patients. The most recent data provided to the FDA shows at least 20 percent of all patients treated with Iclusig have developed blood clots or narrowing of the blood vessels.
The FDA is actively working to further evaluate the adverse events with Iclusig and will notify the public when more information is available. In the interim, health care professionals should consider for each patient whether the benefits of Iclusig treatment outweigh the risks.
Patients who are taking the drug should seek immediate medical treatment if they experience symptoms suggesting a heart attack such as chest pain or pressure; pain in the arms, back, neck or jaw; or shortness of breath. Patients should also seek medical treatment if they experience symptoms of stroke such as numbness or weakness on one side of the body, difficulty talking, severe headache or dizziness.
Any adverse events or side effects associated with Iclusig should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.