FDA Requires Labeling Change On Kidney-Transplant Drugs
July 14 2009 - 1:10PM
Dow Jones News
The U.S. Food and Drug Administration said Tuesday it was
requiring the manufacturers of certain drugs used to prevent the
rejection of transplanted kidneys to warn of certain serious
infections.
The drugs, which include Roche Holding AG's (RHHBY) CellCept,
Myfortic by Novartis AG (NVS) and Wyeth's (WYE) Rapamune, already
carried the agency's toughest boxed warning discussing their
various risks.
The FDA said the new drug labels must discuss an increased risk
of "opportunistic infections," including activation of latent viral
infections such as one caused by the BK virus.
The FDA said such infections may lead to serious outcomes,
including kidney graft loss.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
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