Sales of Iclusig, a drug used primarily in the treatment of chronic myeloid leukemia, were recently suspended in a joint decision between the FDA and Ariad Pharmaceuticals, the manufacturer of Iclusig. Iclusig gained FDA approval less than a year ago, in December, 2012. At the time the drug was approved—under an accelerated process –clinical trials had demonstrated a higher-than-normal risk of cardiovascular events among those taking Iclusig. This risk required Ariad to include a boxed warning alerting patients and physicians to the risks of blood clots and liver toxicity in patients taking Iclusig.
Iclusig Risks
The FDA evaluated the safety and effectiveness of Iclusig based on a trial which included 449 patients. There was no control group in this particular trial; all patients who were in varying stages of chronic myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia and were given Iclusig. The FDA approval of Iclusig was considered important because the drug provided a treatment option for patients who had not responded to other similar drugs or therapies. Iclusig is the third drug approved for the treatment of CML; Gleevec is the most commonly-used drug for the treatment of this serious blood cancer.
Iclusig Dangers Including Iclusig Stroke, Heart Attack and Blood Clots
A recent investigation showed a much higher frequency of blood clots and narrowing of blood vessels than previously thought. In fact, among patients taking the drug for a median time of 1.3 years, 24% experienced these adverse effects, and among patients taking the drug for approximately 2 years, nearly half of all those taking Iclusig experienced serious, sometimes fatal or life-threatening adverse vascular events. These events included stroke, heart attack and blood flow restrictions. Patients currently taking Iclusig may be allowed to continue the drug based on a risk assessment to determine whether the benefits outweigh the potential risks. No new patients will be enrolled in clinical trials at this time, and those currently in clinical trials may have their dosage of Iclusig adjusted accordingly. Dosages of those currently taking Iclusig may be decreased, depending on test results.
Iclusig Used in the Treatment of CML
Chronic myeloid leukemia is rare—only 5,000 new cases a year are diagnosed in the United States. When two separate chromosomes come together to form what is known as the Philadelphia chromosome, this gene fusion creates an aberrant protein, fueling cancer cells into uncontrolled growth. Iclusig, like Gleevec before it, inhibits the action of those errant proteins, changing CML from a death sentence into a chronic—but treatable—disease. Approximately 20-30% of patients have cancers which either develop a resistance to Gleevec, or simply don’t respond to the drug. It is this group of patients for whom Iclusig is primarily used.
Iclusig Side Effects
Common side effects of Iclusig noted during clinical trials included an increase in blood pressure, rashes, pain in the abdomen, chronic fatigue and headaches, constipation, fever, joint pain and nausea. In addition to the serious risks noted above, patients taking Iclusig have suffered: narrowing of the large arteries in the brain, congestive heart failure, symptoms of coronary artery disease which worsen, narrowing of extremity blood vessels (leading to amputation in severe cases), a decrease in vision caused by blood clots in the ocular blood vessels, liver failure, dangerous levels of fluid retention, gastrointestinal perforation, compromised wound healing and pancreatitis. Those patients who feel they have suffered harm from taking the drug Iclusig might benefit from speaking to a knowledgeable attorney.