Iclusig (ponatinib) is a leukemia chemotherapy drug that has been linked to a serious risk of blood clots, heart attack, and stroke. These side effects may occur in as little as two weeks of treatment on Iclusig.
What is Iclusig?
Ariad Pharmaceuticals Inc. developed Iclusig (ponatinib) to treat chronic myeloid leukemia (CML) and Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). It is intended to treat leukemia that is resistant to other chemotherapy drugs. Iclusig was approved in the United States in December 2012.
What is the problem with Iclusig?
Iclusig is controversial because clinical trials have shown that up to 27% of patients develop blood clots, narrowing of blood vessels, or liver toxicity. Experts have known about the risk of blood clots since before Iclusig was approved, but the risk appeared to be smaller. Clinical trials linked Iclusig to an 8% risk of arterial blood clots and a 3% risk of venous blood clots.
FDA Warnings for Iclusig
In October 2013, the FDA published a Safety Communication to warn that clinical trials linked Iclusig to at least a 20% risk of blood clots. The FDA withdrew Iclusig from the market, but allowed patients with leukemia to continue taking the drug. In December, the FDA issued another Safety Communication required new safety studies of Iclusig.
Recommendation for Patients
The FDA recommends that patients on Iclusig should seek emergency medical attention for symptoms of a heart attack or stroke. These symptoms may include chest pain, pain in the arms, back, neck, or jaw, shortness of breath, numbness or weakness on one side of the body, trouble walking, severe headache, dizziness, and more.
Iclusig Risks & Complications
- Blood clots (venous thrombosis)
- Heart attacks (myocardial infarction)
- Worsening coronary artery disease
- Restricted arteries of the brain
- Narrowing of blood vessels in the extremities
- Emergency surgery to restore blood flow
- Congestive heart failure
- Tissue death
- Vision loss and blindness