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©2006-2011 Deborah Wiig
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Should you be concerned if your doctor wants to give you a medication that's approved only for a condition other than the one she's treating you for? Is it ethical? Legal? Safe?

FDA approval is an often-misunderstood concept. Here's how it works: After a rigorous review procedure, the Food and Drug Administration grants approval to a pharmaceutical company to market a new drug for a specific use. This comes after the drug maker has conducted millions of dollars worth of research and trials.

If a drug might be appropriate for more than one use, these costly trials must be duplicated for each one. That's why the manufacturer will choose to market the drug for the use most likely to return their investment. It isn't cost-effective for a drug maker to seek FDA approval for multiple uses of its drugs. Read more about FDA approval.

The manufacturer can promote the drug to the medical community and the public as a treatment for the approved use and no other. The FDA does not govern how members of the medical community choose to use the drug.

When the drug is used for other uses or dosages not mentioned in the approved labeling, it's called "off-label" use. Doctors may legally prescribe a drug for a use not approved by the FDA, and in fact, the FDA "recognizes that off-label use of drugs by prescribers is often appropriate and may represent the standard of practice."

Within the medical community, prescribers develop, publish and exchange information about the most effective treatments for their patients. "Because no FDA-approved drugs are available for many psychiatric disorders," writes Henry A. Nasrallah, MD, Editor-in-Chief, Current Psychiatry, "patients would suffer needlessly if psychotropics were not used off-label."

How common is off-label prescribing?
A 2001 study of Georgia Medicaid enrollees showed that the overwhelming majority of prescriptions for antidepressants, anticonvulsants, and antipsychotics were for off-label indications.

For example, no mood stabilizers have been FDA approved for bipolar II disorder, only for bipolar I symptoms, says author and psychiatrist Dr. James Phelps. "This does not mean that these medications are inappropriate for bipolar II -only that the manufacturers have not bothered to seek such an indication. As a result, virtually all medications used for bipolar II, such as lithium, valproate (Depakote), lamotrigine (Lamictal), and numerous others, are prescribed off-label."

Off-label drug use is good medicine, and it's legal, ethical and as safe as any use of pharmaceuticals. But always be a smart consumer. Do your homework, ask questions and work with a doctor you trust.

Does insurance cover off-label use?
Most health plans recognize off-label prescribing in many circumstances. For example, Cigna Health Care's official policy on off-label drug use is this: "Physicians often prescribe drugs for "off-label" use - the use of an FDA-approved drug for treatment of a condition for which it has not received FDA approval. In certain instances this practice is considered to be experimental. We do not prohibit off-label use of approved medications, but use of certain drugs does require preauthorization."

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Sources
"Off-Label Use of Antidepressant, Anticonvulsant, and Antipsychotic Medications Among Georgia Medicaid Enrollees in 2001" Psychiatric News July 21, 2006, American Psychiatric Association

Nasrallah, Henry A. MD, (2007) Off-label prescribing: Cutting-edge psychopharmacology The Journal of Family Practice, 6(3)

Page updated March 1, 2010