Drug Watch
Diane S. Aschenbrenner MS, RN, CS
Julie J. Chu MSN, CRNP

$3.95 		AJN, American Journal of Nursing
March 2004 
Volume 104  Number 3
Pages 77 - 78
 
  PDF Version Available!

ABSTRACT
Outline

  • GLEEVEC DEMONSTRATES LONG-TERM BENEFITS

  • The FDA grants the drug ‘regular approval.’

  • SEROTONERGIC ANTIDEPRESSANTS AND RISK OF BLEEDING

  • Risk is nearly quadrupled in orthopedic surgical patients.

  • TREATING SYMPTOMS OF ADVANCED PROSTATE CANCER

  • A new injectable drug necessitates monitoring.

  • VITAMIN K1 ADMINISTRATION: ORAL VERSUS INTRAVENOUS

  • Excessive anticoagulation may be treated with oral medication.

    GLEEVEC DEMONSTRATES LONG-TERM BENEFITS

    The FDA grants the drug ‘regular approval.’

    Imatinib (Gleevec), a drug used in the treatment of chronic myeloid leukemia (CML), a rare, life-threatening form of cancer, has been granted “regular approval” status by the Food and Drug Administration (FDA) for use as a second-line drug in treating refractory CML. Imatinib normalizes blood cell counts and reduces the percentage of abnormal chromosomes in bone marrow white blood cells.

    The drug had been fully approved only as a first-line treatment of the nonrefractory form of CML, as well as for pediatric leukemia and gastrointestinal stromal cancer, a rare form of stomach–intestinal cancer. When originally approved under the accelerated approval program (which expedites the approval process for drugs used to treat serious or life-threatening diseases), the long-term benefits of this second-line drug therapy in refractory CML could only be assumed. However, follow-up studies of the patients enrolled in the research studies have shown that 95% of those with refractory disease responded favorably, and after at least two years of drug use, a reduction in the percentage of abnormal chromosomes in bone marrow white blood cells had been maintained in approximately 88% of them. Also, after two years of treatment, disease had not progressed in 85% of patients; ...

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