FDA Advisory Panel Nixes Sodium Oxybate for Fibromyalgia

By Karen Lee Richards, Health Guide Wednesday, August 25, 2010
Last Friday, members of the FDA's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee overwhelmingly voted (20 to 2) against approving sodium oxybate (brand name Xyrem) for the treatment of fibromyalgia.  While most of the panel members agreed that the drug wa...
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8/25/10 6:44pm

I totatally agree with you about the "paranoia". I also understand being careful about prescribing it. Certainly other treatment options should be exhausted before trying it, BUT there are fibro sufferers out there who get no relief at all from the currently available treatments and I think that denying them some relief because of the 'possibility' of abuse is cruel.

 

Anyone who has had a chemisty class can make GHB. The 'recipe' is on the internet. I know a lot of men have fibro, but the majority are women. The potential for fibro patients to use Xyrem to engage in date-rape is probably slim to none. Anyone who does want to use GHB for illegal purposes can readily obtain it on their own.

 

 

8/26/10 10:36am

I particpated in two clinical trials for Xyrem and found it to be so effective that the doctor running the trials continued proscribing the medication for me.  I only went off it due to a heavy travel schedule and the restrictions on liquids in carryons.  The controls are very tight - not only do you have to order each month from a central location, but they verify who you are when you call in, and the delivery must be signed for.  Yes, waking up in the middle of the night so you can go back to sleep is a bit annoying, but as I always wake up anyway, its not a big deal.  If it was in pill form I would still be on it as I had much less pain and much better sleep - a win/win in my book

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By Karen Lee Richards, Health Guide— Last Modified: 10/08/10, First Published: 08/25/10