FDA Requires Labeling Changes For Transplant Drugs

Law360, New York (July 14, 2009, 12:00 AM EDT) -- Federal regulators are requiring the makers of certain immunosuppressant drugs used to protect against organ transplant rejection to update their labeling to reflect that patients are at increased risk for opportunistic infections.

Those infections include the activation of latent viral infections, including BK virus-associated nephropathy, the U.S. Food and Drug Administration said Tuesday in an alert to transplant and nephrology health care professionals. The BK virus has been associated with nephropathy, or kidney damage or disease, in renal transplant patients.

The link to BK virus-associated nephropathy...
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