Here is a link to a letter from the FDA to Novartis, the manufacturer of
this drug.  Apparently the company applied to change the prescribing
information and the FDA approved the changes.  It does not mention any new
information that led to this change in labeling.

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/006035s078ltr.pdf

Barb Berges, BS, RN, IBCLC
near Cleveland, Ohio

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