FDA, Roche Warn On Type Of Anemia With Kidney-Transplant Drug
August 14 2009 - 12:40PM
Dow Jones News
The U.S. Food and Drug Administration on Friday warned doctors
about a certain type of anemia in patients being treated with the
Roche (ROG.VX) kidney-transplant drug Cellcept.
The FDA posted a letter from Roche to health-care professionals
to its Web site on Friday discussing the problem. The FDA said
Cellcept's label has been revised to warn doctors about cases of
pure red cell aplasia.
Last month, the FDA said it was requiring Roche and other
manufacturers of certain drugs used to prevent the rejection of
transplanted kidneys to warn of certain serious infections.
The drugs, including Cellcept, Myfortic by Novartis AG (NVS) and
Wyeth's (WYE) Rapamune, already carry the agency's toughest boxed
warning discussing their various risks.
The FDA said the drug labels must discuss an increased risk of
"opportunistic infections," including activation of latent viral
infections such as one caused by the BK virus.
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