Iclusig Recall Issued Due to Risk of Blood Clots, Blood Vessel Narrowing

Due to the risk of severe and potentially life-threatening blood clots from side effects of Iclusig, Ariad Pharmaceuticals has agreed to suspend sales of the recently introduced leukemia drug.

On October 31, the FDA updated a drug safety communication to announce that the agency asked Ariad to remove Iclusig from the market amid reports of blood clots and severe narrowing of blood vessels.

The agency first issued a warning about the potential Iclusig risks on October 11, announcing that the FDA was investigating an increasing frequency of adverse event reports since the medication was approved in December 2012. As a result of the blood clot problems, Ariad also halted clinical trials due to the potential risks test subjects faced.

Iclusig (ponatinib) was approved less than a year ago for treatment of 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.

When the drug was first put on the market, it was known that Iclusig increased the risk of blood clots, but it appears the level of that risk is much higher than the FDA was originally told. The original clinical trial data Ariad gave to the FDA showed the development of blood clots in 8% of Iclusing users. However, once the drug was on sale to the public, clinical trial data indicated that 24% of Iclusig users studied over a median of 1.3 years suffered serious adverse vascular events. That number jumped to 48%, nearly half, when the median was 2.7 years of use.

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 suspension may not result in a permanent Iclusig recall, as FDA officials are continuing to study the medication to better understand the risks of the drug and to determine if there are patient populations for whom the benefits outweigh the risks. The agency advises patients to discuss whether they should continue to use the drug with their doctors.

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