- Off-label drugs: Question your doctor
- When your doctor prescribes a medication, you assume that the Food and Drug Administration has deemed it safe and effective
for what ails you. That’s not always the case. More than 20 percent of the drugs prescribed are for “off-label” use--that
is, for conditions other than the ones for which they received FDA approval, according to a 2006 study in the Archives of
Internal Medicine.
The range of drugs used off-label is far wider than thought, the federally funded study shows. They include medication for
allergies, convulsions, heart conditions, indigestion, ulcers, and asthma. In 73 percent of the off-label cases, doctors had
little or no scientific evidence to back up their choices.
Drug marketing plays a role, says Randall S. Stafford, M.D., Ph.D., of the Stanford Prevention Research Center in Stanford,
Calif., and co-author of the study. “While direct promotion of off-label uses is illegal,” he says, “there are several gray
areas that provide the industry with an opportunity to increase the off-label use of their products.” Over the past few years,
some drugmakers have paid millions in fines for promoting off-label uses, said an official at the U.S. Department of Justice.
Physicians are not always aware that a particular use of a drug is not FDA-approved, especially if the off-label use has become
commonplace, says Edward Langston, M.D., a spokesman for the American Medical Association. But he says doctors “need the flexibility
to prescribe drugs off-label where it seems appropriate and there’s peer-reviewed literature to support its use.”
Certain off-label uses are appropriate and can even save you a lot of money. For example, some eye specialists use Genentech’s
cancer drug bevacizumab (Avastin), to inhibit the overgrowth of blood vessels in wet macular degeneration, an eye disorder,
says R. Linsy Farris, M.D., M.P.H., a clinical ophthalmologist at the College of Physicians and Surgeons of Columbia University
in New York. Published studies on its use, coupled with results in practice, have been so encouraging that Medicare frequently
covers the cost despite the lack of formal FDA approval, he says.
In 2006, a similar Genentech drug, ranibizumab (Lucentis), was approved for macular degeneration. One injection costs $1,950,
compared with $50 for the off-label drug, according to the April 3, 2007, Annals of Internal Medicine.
What you can do
Ask your doctor whether your medication is FDA-approved for your condition. Or check at the FDA’s Web site (www.fda.gov) or our drug reviews. If it wasn’t, ask why it was prescribed and if there’s scientific support.
