UPDATE:FDA Requires Labeling Change On Kidney-Transplant Drugs
July 14 2009 - 2:01PM
Dow Jones News
The U.S. Food and Drug Administration said Tuesday it is
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 BK-virus infections, characterized by nephropathy,
or a disorder of the central nervous system, can be serious enough
to cause the kidney to be rejected.
The agency said a review of its adverse-event reporting system
and the use of immunosuppressant drugs showed BK-virus infections
were mostly seen in kidney-transplant patients.
The FDA said it was continuing to review the safety of
immunosuppressant drug products.
Last year, Novartis and Roche updated the labels of Myfortic and
CellCept to discuss postmarketing reports of a serious, often
deadly neurological disease known as progressive multifocal
leukoencephalopathy, or PML. The disease is caused by the
activation of a common virus in the central nervous system, most
often in immune-compromised individuals. The virus, known as the JC
virus, sits latent in most adults.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com