FDA Panel Rejects Xyrem as Fibromyalgia Treatment

SteeleyJ

SteeleyJ

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Aug. 20, 2010 -- An FDA advisory panel today overwhelmingly rejected the application of Jazz Pharmaceuticals for the approval sodium oxybate (Xyrem) for the treatment of fibromyalgia.

The drug is chemically similar to GHB, widely considered a date-rape drug. Approving it for such a large patient population -- 5 million people are estimated to suffer from fibromyalgia -- would risk flooding the streets with a pharmaceutical-grade version of the highly controlled substance.

"Sodium oxybate and GHB are the same thing," said panelist Lewis Nelson, MD, of the New York University School of Medicine. "This is much better than the stuff you get on the street, and that is the problem."



Theres more.....
http://www.webmd.com/fibromyalgia/news/20100820/fda-panel-rejects-xyrem-as-fibromyalgia-treatment
 
The experts say that sodium oxybate ( GHB ) is GHB while the reporter says chemically similar to GHB. God i hate reporters sometimes.

I don't think it's right that they wouldn't approve it because it has potential for abuse, what about the people who suffer from fibromyalgia. Just because some people on the street could end up with xyrem they won't approve it. Thats what they make the scheduling system and doctors and pharmacists for.
 
Good! No doctor in his right mind should prescribe GHB when he could easily prescribe the less-addictive Fentanyl or Secobarbital or Ethanol... take your pick.
 
^ You probably think I'm being sarcastic ;).

I actually mean it. I have no idea how something so horrendously-addictive as GHB was approved for anything medicinal...
 
I thought GHB was gammyhydroxybutyrate? How is it also sodium oxybate?

I dont know shit about chemistry but im just curious about that one....
 
Jamshyd said:
Good! No doctor in his right mind should prescribe GHB when he could easily prescribe the less-addictive Fentanyl or Secobarbital or Ethanol... take your pick.
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how addictive something is depends on the person

i know how physically hooking GABA drugs are, but benzodiazpines, barbiturates, etc are prescribed because the cost-benefit ratio calls for it sometimes

GHB taken as directed could be the relief many need but cannot find in current pharmaceuticals

blocking a drug because of abuse potential... what about pain patients? ETC? that's not why they're blocking this, and it shouldn't ever be a reason to block a drug

they're blocking this because they've painted it as a date rape drug, they've demonized it to no end, and if people realize it's another medication like all the others they'll have a bit of 'splainin to do

it's much better for them to have a few people prescribed this than up to 5 million
 
^ I know that banning it because it is a "date rape" drug is ridiculous.

And frankly, I don't care.

Some drugs, like GBL/GHB and Mephedrone, are best left on the pages of chemistry books. There is nothing that GHB offers that currently available drugs don't, and anyone who suffered from its physical witdrawals (which, btw, is not as subjective as you make it out to be) would agree that there really isn't any benefit to counter the "cost". What's the point of taking a drug for pain when taking it becomes a necessity for avoiding even worse pain caused by the drug?

Btw, I say this as someone who is both diagnosed with fibromyalgia AND suffered GBL addiction. Ironically, the symptoms of the former only showed up as I recovered from the latter, leading me to believe that GBL causes irreversible damage that shares a lot in common with fibromyalgia.

Lacey: They are both correct alternate names. Just two different chemical names, like "Acetaminophen/Paracetamol/APAP".
 
yeah jam I did think you were being sarcastic ;-). I dunno bro, I do see both sides of the argument here. I just don't think they should ban something solely based on it's abuse potential, IF they can scientifically prove that this medication works better than ones currently on the market then i beliveve this should be out there. But I haven't looked into the studies on the effectiveness for ghb for fibromyalgia pain. It couldn't hurt to add something to the medicine bag if it does help.

But i do see the other side of the argument, we already have tons of drugs out there that help fibromyalgia and this one would be highly sought after and I've seen people under the influence of ghb try to drive....it's just as bad as alcohol.
 
I thought GHB was gammyhydroxybutyrate? How is it also sodium oxybate?

I dont know shit about chemistry but im just curious about that one....
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it's the same thing, just differerent and less used name to throw people off. It's also called 4-hydroxybutanoic acid
 
What's the point of taking a drug for pain when taking it becomes a necessity for avoiding even worse pain caused by the drug?
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the thing is, jam, your argument can apply to any addictive recreational drug

use of GHB is not necessarily going to physically addict the person unless they use daily. even then, if they are only using it as prescribed, and are taken off the drug slowly enough, there shouldn't be much problem. at least, not any more than people prescribed benzodiazepines/barbiturates/opiates. i know personally how disrupting coming off of a GABA drug can be, and wish i knew how bad it would be before my doctor and i decided long term benzodiazepines was a good idea. still, if you need a med, you need a med, and some are on the med for life and so the addiction is not as much of an issue (although paradoxical effects from tolerance poking through can happen with some people)

in some cases the extreme suffering warrants the drug. deciding to ban a drug because your perception of it as totally not worth it (which, it may not be for you) is exactly how the drug war works. it is possible to use GHB on the weekends or less, and it is possible to use GHB in a way that is therapeutic and sometimes necessary if other meds don't alleviate the suffering

it's also condescending to tell me that i cannot purchase a bottle of GHB because i won't be able to control myself, or to tell my doctor that GHB is an off limits treatment even if the doctor's assessment of cost/benefit differs
 
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