Sign up for our newsletter

Over 175 articles on:

• Mood, anxiety
• Treatments
• Medications
• Lifestyles
• The system
• Book reviews
• People

Help support Mood --
$1/month for a year?

Bookstore

©Moodletter, 2008
For people living with mood and anxiety disorders and others who want to be happier and healthier. Moodletter is a non-profit organization.

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 good medicine? 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 just 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.

When are drugs used off-label?
"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."

Clinicians, in fact, use psychotropics off-label for many legitimate reasons, he says, including these:

• when there are no other options. Almost 90 percent of illness categories in the DSM-IV-TR have an approved drug treatment. Caring doctors will call upon their experience to prescribe treatments that will alleviate their patients' suffering. Research that leads to a drug's eventual FDA approval often begins with the observations of clinicians.
  
• when physicians prescribe dosages based on their real-world clinical experiences with complex illnesses, rather than the drug maker's short-term studies of groups of selected patients.
  
• when doctors continue a drug's use for patients with acute illnesses who get and stay better on a drug which has been approved only for short-term use, while long-term studies continue.
  
• when a drug combination, for example, two or more antipsychotics, is more effective than using a drug approved for use alone.

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."

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

What kind of drugs are used off-label?
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."

Clomipramine (Anafranil) is approved for Obsessive-Compulsive Disorder (OCD) but is sometimes prescribed off-label for depression.

In the Georgia study, 98 percent of prescriptions for gabapentin (Neurontin) were filled for off-label uses. This anticonvulsant, approved for use only in patients who have epilepsy with partial seizures or postherpetic neuralgia, is often prescribed for patients who have generalized anxiety disorder and bipolar disorder.

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.

Related articles
Food and Drug Administration
Guide to psych meds
Working with your doctor
Buying and using meds
Drug profiles

More articles

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)