Iclusig (ponatinib) has been linked to severe and sometimes fatal blood clots, heart attacks, stroke, blindness, and circulation problems that were serious enough to require amputation. In some cases, side effects occurred in as little as 2 weeks on Iclusig.
What is Iclusig?
Iclusig (ponatinib) is a last-resort leukemia chemotherapy drug. It is approved for adults with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). It was created by Ariad Pharmaceuticals and approved by the U.S. Food and Drug Administration (FDA) in December 2012.
Iclusig Linked to 27% Risk of Blood Clots
When Iclusig was approved, the label had a Boxed Warning about he risk of blood clots. Clinical trials indicated that serious arterial clots occurred in 8% of patients on Iclusig, and venous clots occurred in 3% of patients.
The FDA required the manufacturer of Iclusig to conduct post-marketing surveillance studies to determine the risk of blood clots. Recently, the manufacturer provided data linking Iclusig to a 27% risk of blood clots or narrowing of blood vessels.
FDA Warnings for Iclusig
The FDA warnings for Iclusig are summarized in this Drug Safety Communication. In October 2013, the FDA asked Ariad Pharmaceuticals to suspend sales of Iclusig after it was linked to an increased risk of heart attack and stroke. In November, the FDA announced that Iclusig was not permanently withdrawn, and patients with leukemia can continue taking the drug if they desire. In December, the FDA required several studies to address the risk of blood clots and implement safety measures.
Iclusig Side Effects
- Blood clots
- Heart attacks
- Worsening coronary artery disease
- Restricted arteries of the brain and blood vessels in the extremities
- Emergency surgery to restore blood flow
- Congestive heart failure
- Tissue death
- Vision loss and blindness