Posted by utopizen on April 11, 2003, at 0:25:52
In reply to Re: Xyrem and dosage, posted by Sarah S on April 10, 2003, at 21:58:06
> I looked at the FDA page about Xyrem, and it said it would only be prescribed to narcoleptics--and it sounds like they're going to monitor that really closely. So how could a non-narcoleptic person (with no narcoleptic friends either) get their hands on it? I'm always up for a social anxiety treatment, but it doesn't sound like you can get this for psychiatric reasons.
>
Mis-read of what the FDA wrote.The FDA has never, and never will, ever, restrict any drug for any reason to a certain indication for doctors to prescribe within. It only restricts the marketing of it to narcolepsy. Once approved for one indication, it may be approved for another.
The FDA did sound misleading, I'll agree with you there. To confirm this, I did call up the Xyrem hotline, and the maker said that once your doctor prescribes it for any indication, you can have it filled from the central pharmacy that controls it.
And by control, all they mean is only one pharmacy can give it and your doctor has to give them his info to them the first time he prescribes it.
But so far the controls don't require any doctor to climb any hilltops or mountains first...
Once this misinformation stuff goes away, off-label prescribing will sky-rocket. It's already being used by a lot of neurologists off-label, especially for insomnia.
poster:utopizen
thread:218347
URL: http://www.dr-bob.org/babble/20030407/msgs/218416.html