The U.S. Food and Drug Administration (FDA) is probing mounting injury reports associated with Iclusig (ponatinib), a chemotherapy treatment for leukemia, the agency announced.
Injury reports include serious and life threatening blood clots and severe narrowing of blood vessels in both arteries and veins in patients who are being treated with the leukemia chemotherapy drug, Iclusig. Data from clinical trials and received from post-market adverse event reporting reveal that significant adverse events have occurred in patients who are treated with Iclusig and include heart attacks that have resulted in death, worsening coronary artery disease, stroke, narrowing of the large arteries of the brain, severe narrowing of blood vessels in the extremities, and the need for patients to undergo urgent surgical procedures to restore their blood flow.
The agency announced that is working to continue evaluating adverse events and will advise the public when it obtains more information.
Iclusig is a prescription medicine that is used in the treatment of chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL), in adults who are not receiving benefits from prior treatment or who were unable to tolerate other treatment.
Iclusig received FDA approval in December 2012. At the time of the drug’s approval, the label contained information concerning blood clot risk. That information was indicated in the Boxed Warning and Warnings and Precautions sections of the label.
In clinical trials that were conducted before to the drug’s approval, serious arterial blood clots were found to have occurred in 8 percent of patients, and blood clots in the veins were reported in 3 percent of patients treated with Iclusig. The most current clinical trial data submitted by Iclusig’s manufacturer to the FDA, indicated that at least 20 percent of all participants treated with Iclusig developed blood clots or narrowing of blood vessels.
Health care professionals should consider individual patient history, according to the FDA, before prescribing Iclusig, and should weigh the risks and benefits for their patients’ Leukemia treatment. Patient who are taking Iclusig are advised to seek immediate medical attention should they experience symptoms of a heart attack—chest pain or pressure; pain in their arms, back, neck or jaw; or shortness of breath—or stroke—numbness or weakness on one side of the body, trouble talking, severe headache, or dizziness.
Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by completing and submitting the report online to www.fda.gov/MedWatch/report.htm, or downloading the form or calling the FDA, toll-free, at 1.800.332.1088, to request a reporting form. The completed form should be sent to the address on the pre-addressed form, or submit the completed form, by fax, to 1.800.FDA.0178.