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Study Calls for Greater Scrutiny of 'Off-Label' Drug Use
Date:11/24/2008

e a path of so-called individualized medicine, in which drugs or treatments are based on people's unique genetic profile.

"This is the science of the study of average effects -- currently the standard for drug approval and regulation -- running into clinical reality where not every patient experiences exactly the average effect," Flockhart said.

The other drugs on the list are:

  • Bupropion (Wellbutrin) approved for depression, commonly used off-label for bipolar diaorder.
  • Sertraline (Zoloft) approved for depression, commonly used off-label for bipolar disorder.
  • Venlafaxine (Effexor) approved for depression, commonly used off-label for bipolar disorder.
  • Celecoxib (Celebrex) approved for joint sprain/strain, used off-label for fibromatosis -- soft tissue tumors.
  • Lisinopril (Prinivil, Zestril) approved to treat high blood pressure, used off-label for coronary artery disease.
  • Duloxetine (Cymbalta) approved to treat depression, used off-label for anxiety.
  • Trazodone (Desyrel) approved to treat depression, used off-label for sleep disturbance.
  • Olanzapine (Zyprexa) approved to treat schizophrenia, used off-label for depression.
  • Epoetin alfa (Procrit, Epogen) approved to treat chronic renal failure, used off-label for anemia from chronic disease.

A spokeswoman for PhRMA, the drug industry lobbing group, said the group does not comment on off-label drug use, and its members do not promote such use.

More information

For more on prescription drugs, visit the U.S. Food and Drug Administration.



SOURCES: Surrey Walton, Ph.D., assistant professor of pharmacy administration, University of Illinois at Chicago; David Flockhart, M.D., Ph.D., director, Division of Clinical Pharmacology, Indiana University School of Medicine, In
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