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Iclusig Clinical Drug Trials

Iclusig Linked to  Blood Clots and Heart Damage

Thomas J. Henry Attorneys is currently investigating reports of life-threatening side effects associated with Ariad Pharmaceutical’s cancer drug Iclusig. The U.S. Food and Drug Administration halted clinical trials for Iclusig after receiving reports that some patients in the clinical trials had suffered from adverse events including heart damage and blood clots.

ABOUT ICLUSIG

  • Iclusig (ponatinib) received FDA approval in December to be used as a treatment of two rare blood cancers – acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML).
  • Upon reaching the market, the drug carried a label warning of liver toxicity, blood clots, and hypertension.
  • The drug was approved by the FDA in December based on an accelerated approval program which relied on a single study showing that patients responded to treatment.
  • New data submitted to the FDA shows at least 20 percent of patients treated with Iclusig developed blood clots or narrowing of blood vessels.
MULTIPLE ICLUSIG CLINICAL TRIALS SUSPENDED
  • Iclusig was being tested in seven mid-stage clinical trials as a possible treatment for lung cancer, thyroid cancer, and another blood cancer.
  • According to an Ariad news release and as published in Reuters, the suspension of these trials was in response to adverse events including blood clots in 12 percent of patients and heart damage in 6.2 percent of patients.
  • According to Drugs.com and the FDA, other side effects associated with Iclusig include:
    • fever
    • anxiety
    • irregular heart beat
    • seizure
    • cardiac arrest
    • stroke
    • respiratory infection
    • heart attack
    • blood clots
    • narrowing of blood vessels
    • congestive heart failure
    • loss of blood flow resulting in tissue death and amputation
    • decreased vision
    • death
ICLUSIG CLINICAL TRIAL LOCATIONS
  • California
    • UCLA Ronald Reagan Medical Center, Site #027 (Los Angeles, California)
  • Florida
    • H. Lee Moffitt Cancer Center & Research Institute, Site #017 (Tampa, Florida)
  • Georgia
    • Emory Winship Cancer Institute, Site # 058 (Atlanta, Georgia)
  • Illinois
    • The University of Chicago, Site # 001 (Chicago, Illinois)
    • Northwestern University Feinberg School of Medicine, Site # 023 (Chicago, Illinois)
  • Maryland
    • University of Maryland, Greenebaum Cancer Center, Site # 040 (Baltimore, Maryland)
  • Massachusetts
    • Dana-Farber Cancer Institute , Site # 008 (Boston, Massachusetts)
  • Michigan
    • University of Michigan Medical Center, Site # 011 (Ann Arbor, Michigan)
    • Karmanos Cancer Institute, Site # 034 (Detroit, Michigan)
  • Missouri
    • Washington University School of Medicine, Site # 007 (St. Louis, Missouri)
  • Nebraska
    • Nebraska Hematology-Oncology, PC, Site #133 (Lincoln, Nebraska)
  • New Jersey
    • Northern New Jersey Cancer Associates, Site #128 (Hackensack, New Jersey)
  • New York
    • Roswell Park Cancer Institute, Site #029 (Buffalo, New York)
    • Weill Medical College of Cornell University, Site #006 (New York, New York)
    • Memorial Sloan-Kettering Cancer Center, Site #078 (New York, New York)
  • North Carolina
    • Duke University Medical Center, Site #003 (Durham, North Carolina)
  • Oregon
    • Oregon Health and Sciences University, Site #048 (Portland, Oregon)
  • Pennsylvania
    • Jeanes Hospital of Temple University Health System, Site # 127 (Philadelphia, Pennsylvania)
  • Texas
    • MD Anderson Cancer Center, Site # 005 (Houston, Texas)
  • Utah
    • Huntsman Cancer Institute at the University of Utah, Site #043 (Salt Lake City, Utah)
  • Washington
    • Fred Hutchinson Cancer Research Center, Site #100 (Seattle, Washington)

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