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DewDiligence

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DewDiligence

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Re: pcrutch post# 125710

Tuesday, 02/28/2012 11:34:20 AM

Tuesday, February 28, 2012 11:34:20 AM

Post# of 253253
Xalkori (crizotinib) has a new warning in the FDA label:

http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202570s003lbl.pdf

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Drug-induced hepatotoxicity with fatal outcome has occurred. Monitor monthly and as clinically indicated with more frequent testing in patients with Grade 2-4 elevations. Temporarily suspend, dose reduce, or permanently discontinue XALKORI as indicated.

This language was not in the original Xalkori label when the drug was approved by the FDA in Aug 2011.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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