This is not "new" information per se, but for those of you that want all the Tysabri information you can get your hands on, one of our members has dug up the original Biologics Application for Tysabri (what Elan/Biogen submitted to the FDA for the original approval of the therapy). This was made available by a Freedom of Information Application (not ours).
This two part document is nearly 100 pages long and goes to great detail about the drug and its effect on patients (although only including the one year trial data that was available at the time of publication). Interesting sections include 2.4 "Important Issues with Pharmacologically Related Products" and Section 7, "Integrated Review of Safety." Among other things, you will find a number of ominous warnings about the risks of combining multiple immuno-modulating therapies, and furthermore, it provides details on the 9 total deaths that occurred during the trial-- 3 of which were placebo patients!
To our knowledge, this information has not been widely circulated in the MS patient community to this point. We hope you find it useful.
Click "read more" for the links to the FDA site containing these excellent documents.
Advertisement
Link to FDA Articles
Tysabri Biologics License Application to US FDA Part 1
Tysabri Biologics License Application to US FDA Part 2
