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FDA Places Partial Hold on Iclusig Clinical Trials

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Jarod Cassidy4 years ago

Ariad Pharmaceuticals’ stock fell Wednesday as the U.S. Food and Drug Administration placed a partial hold on clinical trials for the company's drug Iclusig following reports of patients suffering from blood clots and heart damage.

About the Iclusig Clinical Trials

  • According to Reuters, Iclusig (ponatinib) is a medication used to treat two forms of blood cancer: chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL).
  • The drug was approved for treatment of these cancers in December with a label warning of blood clots and liver toxicity.
  • Iclusig is currently being tested in seven clinical trials as a possible lung cancer treatment.

Complications in Iclusig Clinical Trials

  • The FDA has placed a partial hold on the clinical trials due to adverse events leading to Ariad’s shares to fall by 77 percent.
  • It has been reported that 12 patients developed blood clots in their arteries after 24 months of treatment with Iclusig.
  • Additionally, 6.2 percent of patients experienced heart damage.
  • According to Drug Information Online other side effects of Iclusig include:

    • chest pains
    • severe pains in upper stomach and lower back
    • high blood pressure
    • anxiety
    • seizure
    • fever
    • irregular heart rate
    • difficulty breathing
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