Life Threatening Adverse Events Prompt Suspension of Leukemia Drug Iclusig (Ponatinib)

Washington, DC: Ariad Pharmaceuticals has suspended marketing of its leukemia drug Iclusig (ponatinib) further to a request by the Food and Drug Administration (FDA). The FDA' request was brought about by reports of the risk of life-threatening blood clots and severe narrowing of blood vessels.

The FDA' recent investigation of Iclusig revealed an increased frequency of blood clots and narrowing of blood vessels since the drug was approved in December 2012. Currently, approximately 24 percent of patients (nearly 1 out of 4) in the Phase 2 clinical trial (median treatment duration 1.3 years) and approximately 48 percent of patients in the Phase 1 clinical trial (median treatment duration 2.7 years) have experienced serious adverse vascular events, including fatal and life-threatening heart attack, stroke, loss of blood flow to the extremities resulting in tissue death, and severe narrowing of blood vessels in the extremities, heart, and brain requiring urgent surgical procedures to restore blood flow. In some patients, fatal and serious adverse events have occurred as early as 2 weeks after starting Iclusig therapy.

The Phase 1 and 2 clinical trials did not include a control group so it is not possible to determine the relationship of these adverse events to Iclusig, however the increasing rate and pattern of the events strongly suggests that many are drug-related. At this time, FDA cannot identify a dose level or exposure duration that is safe. In the Phase 2 clinical trial, adverse events affecting the blood vessels that supply the heart, brain, and extremities were observed in 12 percent, 6 percent, and 8 percent of patients, respectively. Patients with and without cardiovascular risk factors, including patients in their 20s, have experienced these events. Serious adverse reactions involving the eyes, which led to blindness or blurred vision, occurred in Iclusig-treated patients. High blood pressure occurred in 67 percent of patients treated with Iclusig in the clinical trials. Heart failure, including fatalities, occurred in 8 percent of patients treated with the drug.

Legal Help

If you or a loved one has suffered similar damages or injuries, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.

Please click here for a free evaluation of your Suspension of Leukemia Drug Iclusig (Ponatinib) claim

Last updated on Nov-1-13