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I recently read a general news article in my local newspaper (Smith, 2012 ) that reported on the recent U.S. Food and Drug Administration (FDA) approval of two weight loss drugs: Belviq® (lorcaserin) and Qsymia(TM) (phentermine and topiramate extended release). The author, a local consumer health writer for the newspaper, stated that "Qsymia, approved on Tuesday, is a combination of two drugs approved long ago by the FDA: phentermine, an appetite suppressant, and topiramate extended release, which is used for seizures, migraines, and bipolar disorder but was discovered to also cause unintentional weight loss" (Smith, 2012 , para. 3). After reading the article, I sent a brief e-mail to the author and told her that I thought it was unfortunate and misleading that she had described topiramate (Topamax® ) as being used for the treatment of bipolar disorder. I explained that topiramate does not have an FDA-labeled indication for bipolar disorder and that none of the five randomized double-blind controlled studies found topiramate to be effective in the treatment of bipolar disorder. I included copies of the two published papers describing these negative findings (Chengappa, Schwarzman, Hulihan, Xiang, & Rosenthal, 2006 ; Kushner, Khan, Lane, & Olson, 2006 ). In her response to my e-mail, the author commented that, "While topiramate does not have an FDA-labeled indication for bipolar disorder, it is sometimes used off-label for that purpose" (P. Smith, personal communication, July 19, 2012).
Although I know that topiramate is used off label for the treatment of bipolar disorder, why would I believe the author's comment was unfortunate and misleading? Prescribing medications for off-label uses is legal, but is it necessarily appropriate? How does a clinician decide whether off-label prescribing is appropriate? In this month's article, I will discuss the issue of off-label medication use.
What is Off-label Prescribing?
Drugs that are approved for marketing by the FDA carry a product label, which includes information about the drug's clinical pharmacology; what the drug is to be used for (its indication); the patient population for which the approval was granted; the recommended dosage range and duration of treatment; and contraindications, warnings, precautions, and adverse effects of the drug. Product label information is based on data derived from studies submitted...