Off Label Drug Use
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Should your doctor be prescribing you medicine for a condition when using it in that way is not approved by the food and drug administration?
That’s what many physicians are doing.
The Food and Drug Administration evaluates new drugs entering the market. It will also evaluate new uses of medicines already approved.
But that doesn’t mean doctors can’t--and won’t--prescribe medicines for reasons that do not yet have FDA approval.
Take the diabetes medicine glucophage: it is also frequently used to treat the condition called polycystic ovary disease.
But it’s not indicated for that reason.
Like this, 21 percent of all prescriptions are dispensed for reasons that are not FDA approved. In most cases, 3 out of every 4, there is little or no scientific support for those indications.
That’s the finding of the latest research in the archives of internal medicine looking at so called off-label use of drugs.
Dr. Len Horovitz, a pulmonologist at Lenox Hill Hospital, says, “Many practicing physicians will take a drug that is used for something related for instance asthma and use that drug for COPD which is chronic obstructive pulmonary disease which has some of the same symptoms. In that instance it’s a logical extension of how you would treat a lung condition and it makes sense, it just has to be looked at in a more scientific fashion to see if is an effective treatment.”
Those who support off-label use--and there are many--will say it opens doors to new treatments.
“In many situations some of the uses that have come about have been completely serendipitous, just totally luck. For instance we saw that telithromycin is effective in exacerbations of asthma. That was totally a surprise. And of course that would lead one to believe that perhaps there are other antibiotics that are already on the market that might have a use for asthma, and that’s the reason a physician might use an antibiotic other than telithromycin for asthma,” says Dr. Horovitz.
The study found the medication with the most frequent off-label use was neurontin, a neurologic drug prescribed for epilepsy and shingles. 80 percent of the off label use--often for other pain syndromes--was again, associated with little or no scientific evidence to support it.
Critics say off label uses could end up being dangerous because they are not scrutinized closely by any one governing body. They would argue that the evidence documenting the effectiveness of the off-label use in routine practice settings often falls short of what a drug manufacturer would need to provide to the FDA in order to get approval for that new indication.
Still, many doctors believe off label use is ok, it just needs better follow up and documentation.
“This is only dangerous if you are jeopardizing a patient’s safety. These kinds of situations should be monitored in clinical practice with clinical studies and reporting back to drug companies and federal bodies,” Dr. Horovitz believes.
Source:
http://wb11.com/doctormike
Met off-label? 
