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FDA Warns of Adverse Events Linked to Leukemia Drug Iclusig; Sales Halted

Nov 1, 2013

Federal health officials this week warned that taking the leukemia chemotherapy drug Iclusig could cause the thinning of blood vessels and life-threatening blood clots.

Iclusig, available in generic form as ponatinib, is commonly prescribed to people suffering from chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML). The U.S. Food and Drug Administration (FDA) issued a safety alert this week to warn that taking this drug could cause a dangerous narrowing of arteries, and could also cause life-threatening blood clots among people prescribed the drug.

Ariad Pharmaceuticals, the maker of Iclusig, said it will stop marketing and selling the drug while the FDA continues its investigation into the rash of adverse event reports linked to it.

The FDA warned that patients taking Iclusig have suffered fatal heart attacks, a worsening of their coronary artery disease, strokes, and narrowing of the large arteries to the brain. Blood flow has also been restricted to the extremities due to a severe narrowing of the arteries, too, regulators warned. In many cases, patients taking Iclusig have required emergency medical treatment in an attempt to restore normal blood flow to these parts of the body.

Health officials say that these adverse events have occurred in about 20 percent of patients taking Iclusig since the drug was first approved for use in December 2012. In pre-market clinical trials, these events were only recorded in about 3 percent of trial participants.

Physicians are being urged to monitor patients prescribed Iclusig individually. The agency said it is continuing to investigate new adverse event reports and warns patients taking this drug that they should seek immediate medical attention if they experience any of the following symptoms of a heart attack: Chest pain and pressure, pain in the arms, back, neck, or jaw, and shortness of breath; or symptoms of a stroke: numbness and weakness on one side of their body, difficulty speaking, severe headaches, and dizziness.

The FDA said that patients who do not appear to be responding to treatment with Iclusig should consider stopping the drug when they consult with their physicians.

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