Off-label use is the practice of prescribing drugs for a purpose outside the scope of the drug's approved label. The FDA requires numerous clinical trials to prove a drug's safety and efficacy in treating a specific symptom. Once deemed safe and effective, physicians exercise discretion for the use of the drug. It is entirely legal in the United States and in many other countries to use drugs off-label.
More physicians are discovering that many drugs are effective for off-label uses and apply to the needs of their patients. Off-label prescription drugs have become so popular that, today, 1 out of every 4 prescriptions written is off-label. The antiseizure drug gabapentin (Neurontin) is used off-label to treat people with diabetic neuropathy. Another drug used off-label is Lucentis, manufactured by Genentech. It was originally approved for age related macular degeneration, but is now in FDA trials for the treatment of diabetic macular edema. If Lucentis is approved, it would be the first drug to treat this debilitating complication of diabetes.
There are advantages and disadvantages to off-label uses. First (and foremost) is the risk versus reward. You could be the first to experience a breakthrough treatment or you could suffer irreparable consequences from the off-label use. Another consideration is feasibility - often times an off-label treatment may cost you substantially more than the other treatments approved for use. For example, without enrolling in an FDA trial to receive intravitreal injections of Lucentis - it would cost me $2,000 a pop. My peepers are precious, but my pockets aren't that deep! What off-label drug would you consider for use?(With your doctor's blessing, of course).
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