The Dear Doc letter was sent by Biogen Idec and Elan NOT the FDA.  It was not because of new cases with liver damage (see following statement by Sandy Walsh of FDA).  It was sent to bring doctors who treat MS patients current with the labelling for those who treat Crohn's.  BTW, a few years ago Biogen Idec sent the same letter out to doctors warning them of liver damage from Avonex.  All MS drugs have had liver toxicity problems and is NOT unique to Tysabri.  In fact, the incidence for Tysabri is less than some of the other drugs.

 FDA spokeswoman Sandy Walsh, however, said the letter does not reflect new cases but is simply a reiteration of a revised label the FDA approved Jan. 16 as part of the expanded use of the drug for the bowel disorder Crohn's disease. (Reporting by Kim Dixon, editing by Gerald E. McCormick)

Elizabeth Roberts, Health Guide

3/ 6/08 4:44pm

You're correct that the letter came from Biogen and Elan, however, it was the FDA who required them to send it.

 

My purpose here is not to dicker over who/what, but simply to make potential Tysabri user's aware of all potential side effects when making the decision whether or not to use this drug.

 

Thanks for your input.

Nicholas Bumblefuss

4/ 4/08 12:55pm

It is pertinent here to name the fact that Barbara Childs is an Elan Pharmaceuticals stockholder. She launched an internet attack against a single blog post referencing Elan on April 2nd, 2008 because it was not to her liking, and then engaged in a series of false and misleading forum posts on a website for Elan investors in order to incite a mob response. I am not surpised to see her prior attempt here to rewrite your fine article.