FDA rejects new Fibromyalgia drug...

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dc3886
New Member


Date Joined Aug 2010
Total Posts : 12
   Posted 8/26/2010 9:12 AM (GMT -7)   
This article talks about how a new fibromyalgia drug was denied by the fda because of concerns of possible drug abuse.

www.webmd.com/fibromyalgia/news/20100820/fda-panel-rejects-xyrem-as-fibromyalgia-treatment?ecd=wnl_cbp_082610

I know this is a powerful drug, but this is just one of those things where I feel like Fibromyalgia symptoms aren't taken seriously. I'm also annoyed that all of the people that abuse drugs have made it harder for people with real illnesses to get treatment.

Sherrine
Forum Moderator


Date Joined Apr 2005
Total Posts : 17101
   Posted 8/26/2010 11:42 AM (GMT -7)   
Actually, I think they made a good move, myself.  It's not only the risk of drug abuse but they didn't have data about drug interactions for people that take other meds.  Most of us do take other meds.  That would be quite frightening to think a drug could be approved without knowing interactions.  Anything could happen.
 
Also they were worried about risks for patients with multiple coditions and also problems with the complex dosing.  There could be abuse...even accidental.  Many of us are suffering with other illnesses besides fibro so this is a protection for us.
 
I went to a weight loss doctor 40 years ago and he put me on a weight loss medication called escatrol.  They no longer make it because it became a street drug.  It was an upper but I didn't realize it.  I knew nothing about those types of drugs but just blindly trusted my doctor.   Also, even though I took it according to the script...one a day....I did become addicted to it.  I know I wouldn't want to have that happen again.
 
So, I do agree with what the FDA did.  I'd rather they take their times with approving medications than rushing things through that people get sick or even die...like Vioxx. 
 
Thank you, though, for the article!  This gives me more hope that they are really working on finding things to help people with fibro.  So even though this drug wasn't approved, something might come along soon that meets a more strict criteria.
 
Sherrine 
Forum Moderator/Fibromyalgia
************************
God does not give us a spirit of fear, but of power and of love and of a sound mind. 2 Timothy 1:7

dc3886
New Member


Date Joined Aug 2010
Total Posts : 12
   Posted 8/26/2010 11:54 AM (GMT -7)   
Good points, I didn't think about drug interactions. Honestly, I haven't slept in 36 hours so I'm cranky too. I looked up that drug more after I posted this and apparently a lot of people with fibromyalgia are on it already but they just haven't labled it for fibromyalgia so I guess its up to your doctor now to make the choice which is better than handing it out just because it says its for fibromyalgia. I know when lyrica came out and I was told oh its for fibromyalgia it will be great! I tried it for 6 weeks and gained 20lbs with no change in my symptoms. Now I have to lose even more weight. The same thing happed with cymbalta and all I got from that was mood swings and suicidal thoughts. I totally see your point, sometimes you need another opinion to see how skewed yours is.
fibromyalgia, pcos, ibs, anxiety, migraines, arthritis, and insulin resistance

TheChickenPrincess
Veteran Member


Date Joined Jun 2010
Total Posts : 554
   Posted 8/26/2010 12:09 PM (GMT -7)   
DC3886 - this was a good topic to post. I'm glad you shared the info.

When I read the article, it also said it is closely related to and acts just like the date rape drug. Knowing what that drug does, I am relieved that they did not approve this medication.

Just my opinion, however. And you should know that I'm ultra- uber- conservative on medications. If a med hasn't been around and in use for 30 years or more to have a track record, I'm skeptical. I'm definitely not in the main stream.
Why my username? It is real life nickname. I love chickens. Will have my flock of hens one day! :D .............. DX'd with Fibromyalgia, chronic hives, sensitivities and allergies, migraines with auras, tmj, and IBS. Not sure what else!

solar powered
Veteran Member


Date Joined Nov 2007
Total Posts : 538
   Posted 8/26/2010 1:28 PM (GMT -7)   
OK, I have to chime in on this subject. I think I am the only on here who has ever taken xyrem. I was prescribed it by a sleep specialist who believed that fibro is linked to a sleep disorder. I know for a fact that for me it helped me to sleep better thus improving my overall health including the fibro. A lot of medications including many of the ones that we on this site take regularly can be abused, used to cause harm and have side effects. I don't think that is a good enough reason to refuse a patient the possibility of improvement in the quality of their life. Just ask the good folks on the chronic pain board about that. Ingesting ANY MED carries risk and we need to weigh the benefit vs that risk carefully. I was on xyrem for almost 3 years but decided to stop because it started giving me muscles cramps about 1 hour after taking it, waking me up. No sense in taking something for sleep that wakes you up. When I stopped taking it I had no signs of tolerance, dependence or withdrawal symptoms. I just stopped. Many of the other drugs we take can't say that. When taken as directed by an involved and educated dr it can be a "good" medication IMHO. Anyway that's my 2 cents worth. If anyone has any questions about this drug please ask. Lisa
If I can laugh at it, I can live with it.

Stoneoakcroft
New Member


Date Joined Aug 2010
Total Posts : 6
   Posted 8/26/2010 5:37 PM (GMT -7)   
My Dr also wants to deepen my sleep, so far though all it does in knock me down like an anesthetic and make me see things. Obviously i don't like it at all. I have had 2 drugs now cause these problems and i am now becoming scared to take meds. what other options are out there? Pain killers have no affect on me so I'm kinda s(r#w#d. Thanks

SillyMe2
Regular Member


Date Joined May 2010
Total Posts : 110
   Posted 8/26/2010 5:56 PM (GMT -7)   
Similar to a date rape drug.. hmmm. Love the way they would think I would sell my meds. That's pretty insulting..

GreenTeaHero
Regular Member


Date Joined Feb 2010
Total Posts : 181
   Posted 8/26/2010 6:40 PM (GMT -7)   
since it could potentially get on the street as GHB, which i've run into.. i'm glad it wasn't approved... but they really need to get some better meds out there for fibro!!!!

Rascaliggy
Regular Member


Date Joined Jan 2010
Total Posts : 65
   Posted 8/28/2010 8:59 PM (GMT -7)   
HI,
 
I too took Xyrem. Here in Canada it is approved but very carefully monitered. The government actually has to know that you are taking it and will call.  It is the same as" Roffies" or the "Date rape drug" but when taken properly and monitered by your doctor it is good as a sleep medication. It did work for me but after about 6 months I stopped taking it because I was scaring my husband and myself as I was beginning to sleepwalk. We had to put up a baby gate at the top of the stairs so I would not fall down.   shocked
 
Lorraine
Fibromyalgia, Panic/Anxiety attacks, Depression,  
Bi-polar Mood Disorder, IBS, Nodules on Thyroid.
 
Lorraine

Hello~Kitty
Veteran Member


Date Joined Jun 2005
Total Posts : 610
   Posted 8/28/2010 9:58 PM (GMT -7)   
I've researched this medication years ago when I first heard about them trying to get it approved for Fibro, and I have to admit that I'm unsure about my opionion on it. First of all, even though it is basically the date rape drug, we have to remember that narcotic pain medications is in the same family as heroin, but they don't take them off the pharmacy shelf because of that, it has it's place in the medical world, actually a huge place, so why would another drug not be helpful.....?? BUT also I don't want he FDA approving medications for fibro that are scheaduled, it just makes it that much harder to get them prescribed. I can barely get my GP doctor to give me allergy medications, she acts really weird about it, so I would hate to see the way she would react if I asked for something that was scheaduled, and i know alot of doctors are like this. I hate having a condition where I know there is a medication out there that can probably help, but I can't get it cause it has a reputation in causing addiction in a few people that take it, so the doctor is too freaked out to prescribe it.

I just hope that the medical world keeps making advances in treatment and medication that can hopefully give us our lives back someday, even with some trial and error I'm sure they denied this medication due to that fact that it can cause more harm then good to us. Plus it already has too many warnings on this medication, I try not to take medications that have huge warnings...

-kitty

Carmen~*~*~Chronic Pain Moderator

DX-Chronic Pain due to two freak car accidents, Pancreatic Divisum, Fibromyalgia, Asthma, Depression w/anxiety, Migraines, and Kids!!!

Meds- buprenorphene (Subutex) for chronic pain, Cymbalta, prilosec, Zyrtec, ProAir inhaler, and the best medication is my puppy, kitty, and 5 guinea pigs!!!

 


Rascaliggy
Regular Member


Date Joined Jan 2010
Total Posts : 65
   Posted 8/31/2010 7:41 PM (GMT -7)   
Hi,
 
I just recently had to sign an agreement with my doctor regarding the drugs I am taking.  The government is getting a bit skittish here now about opiods and addiction so I had to fill out this form and agreement.  It did not bother me as long as I get the medications that I need.
 
Lorraine
Fibromyalgia, Panic/Anxiety attacks, Depression,  
Bi-polar Mood Disorder, IBS, Nodules on Thyroid.
 
Lorraine
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