Introduction

By Malcolm P. Berger, M.D.

Tuesday, June 22, 2004
 

Welcome to

Offlabel.us

Dedicated to increasing knowledge about off label use of medications 

 

In the United States, medications are licensed by the Food and Drug Administration for use under specific circumstances.  While these uses have met safety and efficacy criteria, there could be other safe and effective uses of these medications that have not been presented to the FDA or do not have enough rigorous statistical support.  What can you do when, as a practitioner, you are faced with a patient who has a condition that has failed FDA approved therapy or who has a condition for which there is no FDA approved therapy?  How can any practitioner make an informed decision without knowledge?  This site will help you acquire more evidence supporting your therapeutic decisions for your patients, third party payers, and especially yourself.

There are many uses that are supported by the published literature.  There are many more which rely on early (pre-1965) published reports, unpublished data or anecdotal accounts.  Some examples are unpublished trials sponsored by pharmaceutical companies. experiences of colleagues and opinions of thought leaders.  Anecdotal accounts need to be fleshed out with evidence that is good enough to be published.  Use, supported by the literature, needs to be expanded upon to create more and better data.  Treatments that have been found to be ineffective or unsafe should not be re-explored outside of controlled trials.  This site will try to help practitioners achieve all of the above goals by providing information and methods to collect and share knowledge about off label use.

All products reviewed on this site are available either over the counter or by prescription.  Products that are not (yet) available in the United States are not reviewed.

FDA Statement on off label use

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