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What Does Using A Prescription Drug "Off-Label" Mean?

April 2013---What Does Using A Prescription Drug "Off-Label" Mean?

Very simply, this means to utilize a prescription medication for a purpose other than what the FDA approved it for. Let me illustrate a few examples.

Lyrica (pregabalin) is FDA approved to treat pain associated with fibromyalgia (along with a few other pain sources). It is also FDA approved as an anti-convulsant, or anti-seizure, medication. Many people have discovered that when they take lyrica, it seems to help combat the symptoms of generalized anxiety disorder. Although the medication has not been approved by the FDA to treat anxiety, certain people use it for this purpose. If the doctor you are dealing with feels it is appropriate, he may prescribe you lyrica for anxiety. Since lyrica is not FDA approved to treat anxiety, this would be considered using it "off-label".

Another case of using a medication, or class of medications off label, is the use of benzodiazepines to stop smoking. This one is a little more dangerous. There are certain doctors that will prescribe a short course of benzos (most common are ativan, valium, xanax) to help a person "get over the hump" when they are trying to stop smoking. Benzos are a class of drugs that you must be very careful with and I have written about them in this blog numerous times.

There are times when off label use of a drug ultimately leads to FDA approval for the use that was previously considered off label. In the case of proscar 5mg (finasteride) it was originally approved for use to treat enlarged prostate. A curious side effect was that it halted hair loss/grew hair back in people suffering from hair loss. People started to use the drug off label to treat hair loss. Eventually the dosage of finasteride was reduced to 1mg and given a new name of propecia. Propecia went on to become FDA approved to treat hair loss, primarily in men. So now you have two dosages of finasteride (5mg and 1mg), under two different names (proscar and propecia) to treat two different conditions (enlarged prostate, hair loss). NOTE: Propecia is not intended for women. Please read my blog post here about this for more information. 

Doctors prescribe medications "off-label" everyday. There is nothing wrong with the practice providing that the decision to do so is well thought out, discussed and planned by both the doctor and the patient.

Chief Kyle J. Fittro

If you are seeing this page as a single blog post, and would like to read more posts about drugs on the chiefteach website, simply click the blog tab at the top right of this page.

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