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Old 10-05-2007, 04:01
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XYREM and off-label prescribing

SWIM knows XYREM (pharmaceutical GHB) is indicated for relatively few disorders (narcolepsy and fibromyalgia, for example). SWIM also knows, however, that once a drug is liscenced, a physician has wide authority to prescribe off-label. From Wikipedia:
Quote:
However, once the FDA approves a drug for prescription use, they do not attempt to regulate the practice of medicine, and so the physician makes decisions based on her or his best judgment.
However, I imagine there must be limits: I can't imagine a M.D. who prescribed phamacutical cocaine for obesity, for example, would have a lengthy career.

Another wiki quote:

Quote:
Xyrem is distributed directly from the manufacturer and cannot be accessed by licensed pharmacists. It is therefore even more tightly controlled than most Schedule II drugs.
So suppose the following scenario: woman approaches her G.P. and says: "Doc, my husband and I would love to have a child, but I have been consistently unable to quit drinking after repeated attempts. I cannot ethically risk bringing a FAS child into this world. But if you could just give me something that closely mimics alcohol, I'm sure I avoid alcohol for the length of my pregnancy."

Doc considers and prescribes Xyrem off-label. What happens to doc?

Incidentally, I think I caught an error when wiki said XYREM/GHB was the ONLY case of one drug having two schedules: what about marijuana and marinol? (Though I suppose you could say marinol is THC and marijuana is a collection of psycoactive substances, if you wanted to nitpick.)
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Old 10-05-2007, 04:21
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Re: XYREM and off-label prescribing

1) Docs have lots of pressure and extra paperwork for off-label prescribing of this drug.
2) RX will not be covered by insurance (xyrem is horribly expensive / dose), and there are only limited pharmacies dispensing this product.
3) Requests are best approached as a short acting sleep aid since GP would likely be reluctant to RX a drug that may have untested safety profile for pregnancies.
4) Also not being able to quit drinking even at the expense of one's unborm fetus would point towards a serious addiction problem, which would make any MD not want to prescribe another potentially addicting drug that can be lethal when combined with alcohol. Most likely SWIY would be blacklisted from any potentially addicting substances. MDs don't appreciate emotional blackmail..
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