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mbutka WRONG on bupe law

Posted by pseudoname on October 31, 2005, at 12:18:38

In reply to Re: Buprenorphine-- bee happy » androog, posted by mbutka on April 8, 2004, at 7:10:32

mbutka said:

> Briefly, the main problem with buprenorphine is it is not approved for treatment of depression, and cannot be used off-label. ... any doctor who prescribes it for anything other than addiction risks losing their license

Perhaps this is true in some other country, but it is NOT the case in the U.S. The following statement is from the U.S. Substance Abuse and Mental Health Services Administration at

21. Can Subutex® or Suboxone® be prescribed for conditions other than opioid addiction, e.g., pain control?

Subutex® and Suboxone® have received FDA approval only for the treatment of opioid addiction. However, once approved, a drug product may be prescribed by a licensed physician for any use that, based on the physician’s professional opinion, is deemed to be appropriate. Neither the FDA nor the Federal government regulates the practice of medicine. Any approved product may be used by a licensed practitioner for uses other than those stated in the product label. Off-label use is not illegal, but it means that the data to support that use has not been independently reviewed by the FDA. Information on FDA policy regarding off-label use of pharmaceuticals is available on the FDA Web site,, or

I just don't want anyone to get discouraged (as I almost was) if they saw mbutka's post in the archive. The only restriction mentioned in those FDA links is that pharma manufacturers cannot actively promote off-label uses.




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