In early October, 2013, Ariad Pharmaceuticals announced updated clinical data from the PACE trial of its drug Iclusig (ponatinib), a drug used in the treatment of chronic myeloid leukemia. Iclusig is primarily used for patients who exhibit resistant or intolerant chronic myeloid leukemia or acute lymphoblastic leukemia. These patients typically have failed to respond to any of the four other medications used to treat these diseases including Gleevec. Although the drug gained FDA approval less than a year ago, due to the ongoing clinical trials, there was a median follow up of 24 months. After serious adverse health issues became apparent in those taking Iclusig, patient enrollment in all clinical studies of the drug are being paused, and marketing suspended, at least temporarily. Ariad officials stress this is not a recall and is not a permanent suspension.
Ariad Pharmaceuticals has entered into an agreement with the FDA which agrees to resumption of sales, marketing and clinical trials, dependent on anticipated changes in dosage and other modifications. Patients who are currently receiving Iclusig in clinical trials and are experiencing no adverse health effects will continue on the therapy, however may have a reduction in dosage from 45 mg. to 30 or 15 mg. Patients who have experienced any type of arterial thrombosis which resulted in a heart attack or stroke will be excluded from Iclusig clinical trials once they resume. Approximately 5,000 people are diagnosed each year with chronic myeloid leukemia, and at least 600 of those will die within a year of their diagnosis.
Iclusig Dangers and Risks
Iclusig is a kinase inhibitor which targets BCR-ABL, an abnormal kinase seen in chronic myeloid leukemia. Patients whose disease has shown a resistance to other tyrosine kinase inhibitor drug therapy have been the primary candidates for Iclusig. Hepatotoxicity and liver failure have been seen in patients being treated with Iclusig. It is recommended that patients have their hepatic functions monitored closely prior to and during treatment with Iclusig. Approximately 4% of Iclusig patients developed serious congestive heart failure or left ventricular dysfunction and there have been four fatalities resulting from these specific Iclusig symptoms.
Some 2% of patients being treated with Iclusig went into hypertensive crisis, while 67% saw significant increases in their normal blood pressure. Pancreatitis occurred in over 6% of Iclusig patients, and serious bleeding events in over 5%, while hemorrhagic events were seen in nearly a quarter of all Iclusig patients. Other risks for those taking Iclusig include: serious levels of fluid retention, myelosuppression, Tumor Lysis Syndrome, compromised wound healing and gastrointestinal perforation. Less serious side effects of Iclusig include abdominal pain, chronic headache, nausea, fatigue, anemia, constipation and dry skin.
Iclusig Blood Clots
On October 9th, Ariad Pharmaceuticals disclosed a higher rate of serious arterial blood clots in patients taking Iclusig; following two years on the drug, 11.8% of patients treated with Iclusig developed blood clots, up from 8% after eleven months. The FDA is currently investigating an increasing frequency in reports of serious and life-threatening blood clots among those patients taking Iclusig.
Iclusig Heart Attacks
Heart attacks, some resulting in death have been seen in those taking Iclusig. Cardiac Arrhythmias leading to the necessity of pacemaker implantation occurred in at least 1% of those patients taking Iclusig. Patients are warned to report any signs and symptoms which suggest a slow heart rate such as fainting, dizziness or chest pain immediately to their physician. Signs of rapid heart rate such as palpitations or dizziness should also be reported. In some patients fatal heart attacks have occurred as early as two weeks from the time Iclusig was started.
Iclusig Stroke and Narrowing of the Arteries
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 urgent surgical procedures to restore blood flow have all been seen among those patients taking Iclusig. The FDA is currently working to evaluate these adverse health effects seen in patients taking Iclusig with a goal of notifying the public as soon as more information becomes available
Fatal myocardial infarction and stroke have occurred in Iclusig-treated patients, with serious arterial thrombosis occurring in at least 8% of those patients. Overall, one in four patients in the Phase 2 clinical trial have experienced serious, life-threatening, adverse vascular events, and 48% of those Iclusig patients in the Phase 1 clinical trial have experienced such life-threatening events. Phase 1 patients have been taking the drug for approximately two years, while Phase 2 patients have been taking Iclusig for approximately 1.3 years.
Legal Help for Iclusig Patients
The FDA is unable, at this time, to identify a dosage or exposure duration of Iclusig that can be considered safe. Patients taking Iclusig who have developed serious, adverse health effects should consult their doctor regarding whether they should continue taking the drug. It could also be to the patient’s advantage to have an experienced Sullo & Sullo attorney evaluate their potential case against Ariad Pharmaceuticals. Sullo & Sullo attorneys have the necessary background and knowledge to help those harmed by a dangerous drug.