BETHESDA, MD 14 July 2009—FDA announced today that the labeling for several drugs used to suppress the immune response after receipt of a kidney transplant must carry new infection warnings.
The agency described the labeling revisions as a classwide change that affects the drugs sirolimus, cyclosporine, cyclosporine modified, mycophenolate mofetil, and mycophenolic acid. In requiring the labeling changes, FDA invoked new authorities granted to the agency under the Food and Drug Administration Amendments Act of 2007.
According to FDA, the labeling for these drugs must state that they place patients at risk for opportunistic infections and the reactivation of latent virus infection. FDA is particularly concerned about cases of BK virus-associated neuropathy, a condition that has been cited in adverse-event reports and can lead to loss of the transplanted kidney.
FDA stated that early monitoring is critical for detecting the condition. The agency stated that adjustments in immunosuppressive therapy should be considered in patients with BK virus-associated neuropathy.
The labeling for the immunosuppressive drug tacrolimus (PDF) already contains a warning about BK virus-associated neuropathy.
