'Off-Label' Drug Use Is Common
Report ID's 14 Drugs Prescribed for Conditions for Which They Are Not Approved by the FDA
WebMD News Archive
Nov. 24, 2008 -- It is common for doctors to prescribe drugs for conditions
they aren't specifically approved for, but in many cases there is not enough
evidence to justify the practice, a new report concludes.
Researchers from Stanford University and the University of Illinois-Chicago
identified 14 drugs widely prescribed for so-called off-label uses that they
say are most in need of additional study.
Six antidepressants and three
antipsychotic medications made the list, and the most common off-label use for
these drugs was the maintenance treatment of bipolar disorder.
The antipsychotic drug Seroquel (quetiapine) topped
the list. The drug was approved for the treatment of schizophrenia and mania-associated biopolar
disorder at the time of the analysis, but the researchers found that three out
of four Seroquel prescriptions were written for other conditions.
In May of this year, the FDA also approved the drug for the maintenance
treatment of bipolar disorder in patients also taking lithium or
The drug's high cost -- averaging about $200 per prescription -- and
concerns about an increased risk of death in dementia patients contributed
to its No. 1 ranking as a medication that needs further study.
Seroquel is often prescribed off-label for the treatment of depression and anxiety, and researcher Randall
S. Stafford, MD, PhD, of the Stanford Prevention Research Center tells WebMD
that it is often prescribed as maintenance therapy to bipolar patients who are
not taking lithium or divalproex.
The researchers concluded that the research on antipsychotics for these uses
In response to the report, Abigail Baron, a spokeswoman for
Seroquel-manufacturer AstraZeneca tells WebMD that the company does not promote
the drug for off-label uses.
It is illegal for pharmaceutical companies to actively market their drugs
for uses that they are not specifically approved for, but sales reps are
allowed to tell doctors about published research that supports these off-label
"Seroquel has helped millions of people suffering from bipolar disorder
and schizophrenia and helped many lead more productive lives," Baron
"It is AstraZeneca's policy to promote its medicines in accordance with
FDA regulation and to train its sales force to follow this policy. We have
extensive policies in place to provide direction about the appropriate
promotion of our product based upon the FDA-approved indications and consistent
with FDA regulations."
Drugs That Need More Study
Stafford agrees that off-label prescribing is an important feature of
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."