Iclusig Side Effects Linked to Reports of Blood Clots: FDA

Federal drug regulators are warning that potential side effects of the cancer drug Inclusig may be linked to serious and potentially life-threatening blood clots and narrowing of blood vessels.  

On October 11, the FDA issued a drug safety communication for Inclusig (ponatinib), a cancer drug by Ariad Pharmaceuticals Inc. that has only been on the market since December 2012.

The statement was issued to announce that the FDA is investigating an increasing frequency of adverse event reports involving blood clots and severe narrowing of arteries and veins among patients taking the leukemia chemotherapy drug.

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Ariad told the FDA last week that it has stopped enrolling patients in clinical trials involving the drug due to concerns about the risk of blood clots.

The FDA warns that patients taking Iclusig should seek immediate medical attention if they experience symptoms like those of a heart attack or stroke, including:

  • Chest pain or pressure
  • Pain in the arms, back neck or jaw
  • Shortness of breath
  • Numbness or weakness on one side of the body
  • Trouble talking
  • Severe headache
  • Dizziness

These could be signs of a potential blood clot or severe narrowing of the veins linked to Inclusig side effects.

Inclusig already carries a blood clot warning because the clinical trials Ariad gave to the FDA for the drug’s approval suggested blood clots occurred in 8% of the patients. However, in clinical trial results given to the FDA after the drug had already been approved for the market, the rate of blood clots was 20%.

The drug is used to treat chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia. It is reserved for patients who no longer benefit from or tolerate other treatments.

According to the FDA, data from the clinical trials showed patients suffered heart attacks, death, worsening coronary artery disease, stroke, restricted arteries of the brain and blood vessels in the extremities and the “need for urgent surgical procedures to restore blood flow.” Other problems the FDA reports that patients have experienced include congestive heart failure and tissue death requiring amputation. There have also been reports of vision loss and clots of blood vessels in the eye.

The FDA warns health care professionals to consider whether the benefits of Inclusig are worth the risks for each patient.


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