Quote:
Originally Posted by Becca44
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)."