Misstified
Journeyman
Reged: 11/23/04
Posts: 72
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Recently Approved MS Drug Yanked From Market
Safety Questions Lead To Suspended Sales Of Tysabri
POSTED: 8:53 am CST February 28, 2005
BOSTON -- Biogen Idec Inc. and Elan Corp. are pulling a new drug for multiple sclerosis off the market.
The companies suspended sales of Tysabri after one patient died from multifocal leukoencephalopathy, a rare disease of the central nervous system. Another patient has a suspected case of the disease.
In a statement, the drugmakers said they have stopped supplying and marketing the drug. They also advised doctors to stop prescribing it.
The Food and Drug Administration approved Tysabri in November in an accelerated process. A late-stage study showed it cut MS relapses by 66 percent compared to a placebo.
"Because we believe in the promising therapeutic benefit of Tysabri, we are working to evaluate this situation thoroughly and expeditiously," said Dr. Burt Adelman, executive vice president of development at Biogen Idec. "While we work through this matter, we must place patient safety above all other considerations."
Patients and physicians with questions should call (888) 489-7227.
http://www.channeloklahoma.com/health/4237846/detail.html
I was trying to find a way to try that too with no insurance it's out of my reach financially , but sometimes I guess it's better not to have insurance , i don't understand sometimes how these things don't get noticed during the clinical trials .. do they rush through them ? pay off the FDA for approval too quickly? I feel so badly for those people that had so placed so much hope in this med and for those who died , how very sad.
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..and the ones that mother gives you, don't do anything at all..
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Daeshay76
Old Hand
Reged: 03/22/04
Posts: 459
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I want to thank you for this info. My brother has MS and his doctors and the drug reps have been trying since November to get his ins to approve and a hosptial to admin this drug to him. The hospitals because of the risk and to me that was a godsend after reading this. I called my sis-in-law about this and told her and she told me that the drug rep would sugar coat the side effects of this medication.i and my family can not thank you enough for posting this if you had not we probably would of not known about the dangers in this. Thank you so much!!!
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bankshot2
Stranger
Reged: 01/20/05
Posts: 12
Loc: USA
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daeshay - Hi, this is my first post here, so hello everyone. I have MS and have been on Avonex (which is also made by Biogen) for 4 years. I was not even aware that they were working on another drug when the Avonex is working so well (on me at least). I understand that some people can't tolerate Avonex so I guess that's why. Is your brother on Avonex, Betaserone or Copaxine (SP?)? These have all been around for awhile and I think are relatively safe, also Rebiff (sp?) has been approved in Canada but not in the US, I really don't keep up on these things like I should but I think Rebiff or Rebuff, (sorry) is a stronger form of Avonex. I just had a repeat MRI that shows that there has been no change in the lesions in 4 years, they are not gone but there are no new ones and they have stayed the same size and I have had no further major flare-ups. My neuro says we can't tell if it's because of the Avonex or not since I have relapsing/remitting, I may just be in remission but says that it's not worth the risk to stop taking it.
Misstified - thanks for that info, my neuro has not suggested changing anything but if he even mentions that drug I will now be informed of its danger.
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Daeshay76
Old Hand
Reged: 03/22/04
Posts: 459
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Bank...welcome! I am glad you are doing so well with the Avonex. My brother has been on every single one you mentioned but i think it may just be his body makeup to where he gets really sick with them...you know when you take it you get the flu like symptoms...well for him he gets those but they are 1,000 times worse and doesnt go away so he stays so ill from shot to shot so his doc thought that this new drug would be the best for him. His last MRI showed more leisions on his brain and he has never really been in remission at all recently he was in a wheelchair::sniff sniff:: i wished i knew what i could do to help him but i dont...he has severe headaches all the time from all the leisions on his brain but his neuro doc will not let him take the other meds because he gets so ill on them. the only things that is making him feel better right now is steriods (oral) i dont recall the name of what he is taking but it has gotten him out of that darn wheelchair. if anyone would like to talk about this with me please feel free to PM me at anytime i am open for anything that may help my brother. i have even contacted Montel Williams about my brother...
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bankshot2
Stranger
Reged: 01/20/05
Posts: 12
Loc: USA
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daeshay - I'm so sorry to hear your brother isn't responding or tolerating the meds. I have been very lucky, I was diagnosed really quickly and the flu-like symptons were only bad the first 6 months, then my body seemed to adjust to it. I was one of the lucky 2% who began losing my hair though, but that stopped too after about 6 months and it was thick to begin with. I was on high dose iv solumederal for 3 days twice with a 2 week taper and I really feel for your brother because I hated those steroids. I think it was the high dose aspect of it though that made the reactions so extreme. They literally drove me crazy, I couldn't eat anything but grapes because everything tasted like metal but I gained 20 lbs anyway. I'll keep your brother in my prayers, I don't know why but it seems to hit men worse than women, my neighbor who was dx'd a month before me (weird huh?) is kind of in the same state as your brother, he can't tolerate the meds and had to quit work and go on disability because he was a house painter and could no longer walk let alone climb a ladder. It is really a shame because he is 10 years younger than me and he and his wife had only been married 1 year and were starting to try to have a family. Now all that has been put on hold. I am so glad I had my kids before I was dx'd or I probably would have had 2nd. thoughts because of the uncertainty of the disease.
Like I said, I am very new to this board, so I have to do some looking around to find the pm and such, just have to read all that new user stuff I guess. Take care, bankshot
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