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missvicki
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Joined: Nov 20, 2006
Posts: 53
Location: Denver
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 Posted: Wed Feb 27, 2008 9:44 pm Post subject: Multiple sclerosis drug linked to liver injury |
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I know this is not great news for some but thought you would want to know.
http://www.msnbc.msn.com/id/23375161/ |
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HarryZ
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Joined: May 26, 2004
Posts: 1359
Location: London, ON, Canada
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| Posted: Thu Feb 28, 2008 8:26 am Post subject: Re: Multiple sclerosis drug linked to liver injury |
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This is a link that I picked up from another MS website. It's a letter from Biogen/Elan that was written to health care professionals re: the problem.
http://www.fda.gov/medwatch/safety/2008/Tysabri_dhcp_letter.pdf
What puzzles me is that it refers to problems that are being discovered in the "post marketing" period use of Tysabri. This drug was in trials for more than two years for both MS and Crohn's patients. During trials, patients are monitored very closely for problems like this. Are we now being told that this alert is something new and that Biogen/Elan were not aware of it prior to this time?
Harry |
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2gentle
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Joined: Feb 13, 2004
Posts: 66
Location: Fort Smith Arkansas
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| Posted: Thu Feb 28, 2008 1:43 pm Post subject: Tysabri Warnings... |
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Thanks Harry for posting this. Several of my MS friends won't even consider taking Tysabri, because they believe it was released too soon.
I agree w/them 100%!But then I think most meds are released waaay before they should be. 
Gentle
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Every journey begins with a single step...Diane |
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Jean
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Joined: May 22, 2007
Posts: 47
Location: France
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| Posted: Thu Feb 28, 2008 3:13 pm Post subject: |
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| That's not very surprising to me. Many treatments may be linked to liver injury. Even high-dose paracetamol may cause liver damage ! And the interferons too. That's why people treated with Avonex, Betaseron or Rebiff have to make blood draws regularly to check liver function. [/quote] |
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Lyon
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Joined: May 04, 2006
Posts: 3403
Location: Mid-Michigan
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| Posted: Thu Feb 28, 2008 3:24 pm Post subject: |
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Good point Jean.
Deciding NOT to treat your MS is not risk free and NONE of the medically accepted treatments are risk free.
There are no easy decisions with MS.
Bob
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Wife diagnosed with MS in Feb. 2006 and is a participant in the Tovaxin IIb clinical trial. |
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HarryZ
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Joined: May 26, 2004
Posts: 1359
Location: London, ON, Canada
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| Posted: Thu Feb 28, 2008 3:31 pm Post subject: |
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| Jean wrote: | | That's not very surprising to me. Many treatments may be linked to liver injury. Even high-dose paracetamol may cause liver damage ! And the interferons too. That's why people treated with Avonex, Betaseron or Rebiff have to make blood draws regularly to check liver function. |
You are right in stating that it isn't surprising that liver problems can occur from using very powerful drugs like Tysabri.
What I DO find surprising is that Biogen/Elan are just now issuing a warning to physicians about this problem that they state has only recently begun to show up. My question is why this kind of problem wasn't discovered in over two years of MS and Crohn's trials.
Harry |
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Jean
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Joined: May 22, 2007
Posts: 47
Location: France
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| Posted: Thu Feb 28, 2008 6:24 pm Post subject: |
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You're right. That's not the same problem. But,
| Quote: | | ...the liver risk has been debated since at least last year, including at an FDA advisory panel. |
(msnbc article)
In fact, I think the liver problem was already suspected, but with a 1/1000 ratio, it was probably not seen during trials (1/1000, that's difficult to see, even for a phase III trial)
This announcement is probably the "official" warning of Biogen. By doing this, they protect themselves against claims for "hidden side effects" which could be issued. |
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HarryZ
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Joined: May 26, 2004
Posts: 1359
Location: London, ON, Canada
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| Posted: Thu Feb 28, 2008 8:37 pm Post subject: |
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| Quote: | | In fact, I think the liver problem was already suspected, but with a 1/1000 ratio, it was probably not seen during trials (1/1000, that's difficult to see, even for a phase III trial) |
The 1/1000 number was a Biogen "estimate" for "severe liver damage". How many other liver problems are occurring with Tysabri? ! The article went on to say that in a number of cases, the liver problems stopped when the drug was stopped and then they re-appeared when Tysabri was started again. You begin to wonder just what "a number of cases" means! I'm sorry that I just don't trust Biogen in all of this.
| Quote: | | This announcement is probably the "official" warning of Biogen. By doing this, they protect themselves against claims for "hidden side effects" which could be issued. |
Why do I fear that this is just the tip of the iceberg of Tysabri problems to come?!
Harry |
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trrish
Getting to Know You...
Joined: Feb 21, 2008
Posts: 11
Location: Boulder, CO
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| Posted: Fri Feb 29, 2008 2:20 pm Post subject: |
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I think it is easy to fear that. It's a new and powerful drug. Thought I can't imagine that most drugs don't cause some impact on the liver, actually.
Because I'm on Tysabri, I choose not to be driven by fear about it. It has helped me immensely when none of the other drugs did. I am very aware, though, that it may all come to a screeching halt. I guess it is a tradeoff that so far, I've been willing to make. It's better to have loved and lost? |
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