FDA Asks for Halt in Sales of Blood Cancer Rx

Blood clot and death risks linked to Iclusig lead FDA to call for suspension of marketing and sales of the medication

/ Author:  / Reviewed by: Chris Galloway, M.D. Beth Bolt, RPh

(RxWiki News) The US Food and Drug Administration (FDA) has asked the maker of a medication that has been used to treat two types of leukemia to stop selling that product.

FDA officials based their request on an increase in life-threatening blood clots among users of the medication Iclusig (ponatinib).

Iclusig was approved by the FDA in 2012 for use in adult patients with either chronic myeloid leukemia (CML) or Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).

Last week, the FDA began advising doctors and patients for whom Iclusig did not improve their illness to consider other medications that may help.

However, patients for whom Iclusig has worked and who have no other treatment options are being advised to talk with their doctors about whether the medication's benefits outweigh the risks.

"Ask your doctor about your medication's risks and benefits."

As the FDA continues to determine the potential dangers and benefits of Iclusig, it has advised the following:

  • Patients who thus far have not taken Iclusig should not be prescribed Iclusig, unless there are no other treatment alternatives.
  • Patients currently using Iclusig and for whom the benefits appear to outweigh the risks should apply to use other medications that have not been fully approved by the FDA. Those potential alternative medications are not part of a current clinical trial.

Ariad Pharmaceuticals, based in Cambridge, MA, makes Iclusig and is cooperating with the FDA's ongoing investigation of this medication.

"Ariad believes that Iclusig is an important medicine for patients with resistant or intolerant Philadelphia-positive leukemias and is actively working with the FDA on actions to achieve the resumption of marketing of Iclusig," company officials announced.

Ariad executives have said that no earlier tests of Iclusig proved that symptoms of the two blood cancers decreased or that patients lived longer as a result of using the medication.

Ariad's own warnings on medication packages noted that Iclusig has caused problems, including pancreatitis, uncontrolled bleeding, blood clots, fluid retention, high blood pressure, irregular heart beat, stroke, liver failure, congestive heart failure and kidney-damaging tumors in some patients.

In some cases, Iclusig users died, the company also disclosed.

The FDA's review of Iclusig found that after 1.3 years, about 24 percent of patients in the second stage of clinical trials on the safety of Iclusig and 48 percent of those in the first stage of clinical trials "...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 [two] weeks after starting Iclusig therapy."

The FDA continued: " … [A]dverse 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."

Some patients were blinded or developed blurred visions from Iclusig, the FDA reported.

"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," the FDA wrote.

Review Date: 
November 3, 2013
Last Updated:
November 4, 2013