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'Off-Label' Drug Use Is Common

Report ID's 14 Drugs Prescribed for Conditions for Which They Are Not Approved by the FDA

Drugs That Need More Study

Stafford agrees that off-label prescribing is an important feature of clinical practice.

But he says many of the most common uses for the drugs identified in his report have not been adequately studied.

There are situations where it makes sense, especially when there are few other treatment options, he says. "But we are talking about millions of prescriptions a year, and the size and rigor of the studies that have been done may not justify this."

The blood thinner Coumadin (known generically as warfarin) was included in the report. The drug is widely prescribed for the treatment of hypertensive heart disease and coronary heart disease, but it is not approved for these uses.

Two other antipsychotics -- Risperidal (risperidone) and Zyprexa (olanzapine) -- also made the list. Both are approved for the treatment of schizophrenia, but are often prescribed off-label for the treatment of depression.

The six antidepressants identified in the report included:

  • Lexapro (escitalopram)
  • Zoloft (sertraline)
  • Effexor (venlafaxine)
  • Cymbalta (duloxetine)
  • Wellbutrin (Bupropion)
  • Desyrel (trazodone)

Once again, the treatment of bipolar disorder was the most common off-label use for most of the antidepressants identified in the report.

The four other drugs identified in the report were:

  • The asthma drug Singulair (montelukast), commonly prescribed off-label for chronic obstructive pulmonary disorder (COPD).
  • The arthritis drug Celebrex (celecoxib), with fibromatosis being the most common off-label use.
  • The ACE inhibitor Prinivil or Zestril (lisinopril), most commonly used off label for coronary artery disease.
  • The drug Procrit or Epogen (epoetin alfa), approved for anemia in patients with kidney failure, but widely used in patients with other chronic diseases.

"We are not trying to say that these uses are necessarily bad," University of Illinois-Chicago economist and study researcher Surrey M. Walton, PhD, tells WebMD. "It is just that there hasn't been enough evidence established for it."

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