FDA Investigating Ponatinib After Increased Reports of Serious Blood Clots in Arteries and Veins
The U.S. Food and Drug Administration (FDA) is investigating an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels of patients taking the antileukemia drug ponatinib (Iclusig).
Ponatinib is indicated for the treatment of patients with chronic-phase, accelerated-phase, or blast-phase chronic myeloid leukemia or Philadelphia chromosome–positive acute lymphoblastic leukemia, who are no longer benefiting from previous treatment or who did not tolerate other treatment.
Serious Adverse Events in Clinical Trials
At the time of ponatinib’s approval 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 ponatinib-treated patients, and blood clots in the veins occurred in 3% of ponatinib-treated patients. In the most recent clinical trial data submitted by the manufacturer to FDA, at least 20% of all participants treated with ponatinib have developed blood clots or narrowing of blood vessels.
Data from clinical trials and postmarket adverse event reports show that serious adverse events have occurred in patients treated with ponatinib, 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 extremities resulting in tissue death requiring amputation. Newly identified serious adverse reactions have also been reported involving the eyes, including decreased vision and clots in blood vessels of the eye. These adverse events were seen in all age groups treated and in those with and without cardiovascular risk factors.
Report Side Effects to FDA
Health-care professionals should consider for each patient whether the benefits of ponatinib treatment are likely to exceed the risks of treatment.
Patients taking ponatinib should seek immediate medical attention if they experience symptoms suggesting a heart attack such as 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.
FDA is actively working to further evaluate these adverse events and will notify the public when more information is available. Health-care professionals and patients are urged to report side effects involving ponatinib to the FDA MedWatch program.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
