Unfortunately, I'm not going to believe for one minute that this liver problem has suddenly shown its ugly face with Tysabri patients. The drug was in MS trials for more than two years. Same for Crohn's patients. During the trials these patients are monitored very closely. That's what they do in drug trials.

The responsibility of reporting what happened in the Tysabri trials lies with Biogen/Elan. I have never been a fan of those companies and have always questioned if we were being told everything about Tysabri. You start to hear information like this and it makes you wonder. I sure hope that MS patients are not again going to be subject to another possible therapy that may do more harm than good in the long run!

Harry

I find this very troubling. I thought that, surely, blood testing for possible liver damage is a must do for all of the DMDs.

Please do ask you Neuro and have a test soon, Barb..

VIAL= bottle that contains drug. Lot # and expiration date are on bottle.

Box= container that vial comes in. Date of expiration and Lot # are on box end

Drug Monograph for Patient= That paper that is folded about twenty times and is tissue thin that gives every drop of scientific and FDA required information on and about drug. Found stuffed in every box of Tysabri.

Not sure why that would have anything to do with someone being checked by their neurologist for liver function or blood"checks"

Thanks Riverwild. I thought your "vial and box" comment was in answer to the question of whether people are currently having their blood/liver checked i.e. thought you were suggesting that people should be asking for a vial (of blood) to get it checked themselves.

It doesn't seem the liver is being checked regularly as part of standard protocol? So, I suppose this letter was just to advise doctors of the risk, and to tell them to casually observe if their patients start turning yellow or getting very sick then.

Cherie

Here here. The after market data on this drug continues to trickle in and I'm still not a fan - neither is my neurologist. Might it be a different story if I were experiencing more rapid progression? Absolutely. But it still makes me mad.

Liver damage is a risk with Tylenol ....but millions upon millions of people take Tylenol.

Liver damage was something I experienced on Avonex. Testing me every six months caught - in time - problems that could still be addressed and rectified: Severe liver damage within 6 days is quite another story. At least in my mind it is. I think it's a little cavalier (as Cherie seemes to suggest) to deal with this simply by suggesting people be on the look out for jaundice - something that indicates severe damage is already done.

As usual, no problems, no concerns. Nothing to report, just a usual day. I did have a delicious blueberry muffin though!

My nuero told me he would be checking liver function ever other mo. I prob. could bump it to every mo. I'll think on that one. Thanks for the info. ~Sheena~

This information guide ( also known as a monograph) is included in every box of Tysabri. It is also included in the back pocket of the Tysabri Booklet " The Strength to Reach Your High Hopes " .

http://www.elan.com/

Click on "Full Prescribing Information and Medication Guide

It's a PDF and it's long. It includes all new information added for Crohn's treatment.

The package insert identifying liver damage as a risk to Crohn's patients has been in place since January 2008. This new warning expands the area of concern to MS patients receiving Tysabri, doesn't it?

From what I gather, liver damage with Tysabri has been openly discussed since the latter part of 2007. I have to assume it's on the radar longer than that... It also appears the damage can happen at any time during treatment (which is also the case with the inteferons, I experienced that ) but that it can be rather severe and fast moving so hopefully, this will lead to more aggressive testing for liver damage.

Don't get me wrong - I love that Tysabri is an option for all of us - me included, even though I'm not considering it at present - but it's no silver bullet and it does come with a set of risks. Those risks are ever evolving and I think it's fair to be able to discuss them freely and honestly.
becca44

This package insert was just approved. I have a vial and monograph from my infusion yesterday and it was not the same monograph.

I also have a copy of a draft with corrections and blacked out areas found on the FDA website a few days ago dated Feb. 21st that contains all the information in the new published version.

FYI- News first disseminated ahead of July advisory panel for Crohn’s. The FDA released slides ahead of the Jul 31 panel for Tysabri in Crohn’s showing 28 unduplicated cases of liver injury when using Tysabri, with 4 being serious despite no liver injury signal being identified in Tysabri clinical trials. All 4 patients with serious liver injury fully recovered, with no deaths or liver transplants. Importantly, during the actual Crohn’s panel, the members paid very little attention to the small liver risk, and ultimately approved the drug regardless.
Liver risk included in label. Importantly, this news is no different from what is already included in the Tysabri label, which was updated upon the approval in Crohn’s disease on Jan 14. The updated label was based purely on the data at the Crohn’s panel, and included no new cases. The label specifically states that “TYSABRI should be discontinued in patients with jaundice or other evidence of significant liver injury (e.g., laboratory evidence)."