In an almost unprecedented move, Ariad Pharmaceuticals, Inc., recently suspended marketing for the chronic myeloid leukemia drug, Iclusig. Iclusig, also known as ponatinib, has been linked to severe and even fatal heart attacks, strokes, blindness and loss of blood flow in the extremities which, in extreme cases, can result in amputation of the limb. Iclusig was approved by the FDA less than a year ago; at that time, the label carried a warning, advising consumers of the potential for blood clots to develop in some people. In the initial studies, approximately 8% of patients taking Iclusig suffered serious blood clots in their arteries, and 3% suffered blood clots in the veins. After only a few months on the market, however, the FDA is now reporting that 24% of patients taking the drug for up to 1.3 years, and 48% of patients taking Iclusig for up to 2.7 years suffered “serious adverse vascular events.”

At this point, Iclusig is not being recalled or permanently withdrawn. The FDA plans to work with Ariad Pharmaceuticals in order to identify those patients who could still reap some benefits from Iclusig. Chronic myeloid leukemia, the disease treated by Iclusig, can be fatal, and, in some instances, the drug may be able to keep people with the disease alive when no other treatment has worked. Approximately 5,000 new patients are diagnosed with chronic myeloid leukemia each year in the United States, with at least 600 deaths. At this juncture, patients who choose to continue taking Iclusig—despite the stated health risks—can do so. Iclusig can be prohibitively expensive, costing more than $100,000 per year, with some patients expecting to require the drug for life. This means Iclusig could change chronic myeloid leukemia into a chronic disease rather than a death sentence.

Prior to Iclusig, the drug Gleevec was used to fight a specific genetic effect, however some patients suffered a specific mutation which rendered their cancer resistant to Gleevec and similar drugs. These patients appeared to respond to Iclusig—one of only four drugs currently approved in the treatment of blood cancers. When Iclusig was initially marketed, the listed side effects of the drug included skin rashes, abdominal pain, fatigue, headache, dry skin, fever, joint pain and nausea. Packaging noted that Iclusig could interact with heart or blood pressure medications, antibiotics, medications used for hepatitis C, HIV, AIDS and antifungals, causing further health problems.

Phase 1 and 2 clinical trials for Iclusig failed to include a control group, therefore the relationship of Iclusig to serious adverse health events cannot be definitively shown. Nevertheless, the increasing rate and pattern of adverse health events among those taking Iclusig strongly suggests they are tied to the drug. High blood pressure occurred in 67% of patients treated with Iclusig; liver failure, congestive heart failure, pancreatitis, hemorrhage, fluid retention, cardiac arrhythmias, myelosuppression, compromised wound healing and gastrointestinal perforation are also serious side effects associated with Iclusig.

Unfortunately, the FDA has identified patients who experienced serious adverse health events or even death within two weeks of beginning Iclusig. Some of those patients had no risk factors for heart disease, and some were as young as in their 20’s. Because of such serious, adverse health risks, Iclusig will likely be used only on those patients who are showing improvement while taking the drug, or those who have very few alternate options available for treatment of their chronic myeloid leukemia disease.

New patient enrollment in clinical Iclusig trials has been paused, however it is expected to be resumed following changes in dosage and certain other modifications. Patients who are already enrolled in an Iclusig clinical trial will continue, however dosage reductions will be implemented; from 45 mg. to 30 mg. daily unless a major molecular response has been noted, in which case the dosage will be reduced to 15 mg. daily. The eligibility criteria for those taking part in an Iclusig clinical trial will be modified to exclude patients who have experienced arterial thrombosis which resulted in a heart attack or stroke.

PACE trial data notes a continued efficacy of Iclusig following dosage reduction. Those who have been harmed by Iclusig could benefit from speaking to a knowledgeable product liability attorney, well-versed in the legal process regarding dangerous drugs. The attorneys of Sullo & Sullo have the experience, background and compassion necessary to help those harmed by a dangerous drug such as Iclusig. Call 855-520-6650 today for a comprehensive assessment of your case based on your individual circumstances.