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FDA Requires Labeling Changes for Immunosuppressant Drugs ROCKVILLE, Md -- July 14, 2009 -- The US Food and Drug Administration (FDA) is requiring the makers of certain immunosuppressant drugs to update their labeling to reflect that immunosuppressed patients are at increased risk for opportunistic infections, such as activation of latent viral infections, including BK virus-associated nephropathy. Class labeling changes are required for the following immunosuppressant drugs: · sirolimus (Rapamune) · cyclosporine (Sandimmune, Neoral, and generics) · mycophenolate mofetil (Cellcept and generics) · mycophenolic (Myfortic) The FDA conducted analyses of its Adverse Event Reporting System (AERS) to characterise the association between BK virus-associated nephropathy and the use of these immunosuppressant drugs. The occurrence of BK virus-associated nephropathy is primarily observed in renal transplant patients. BK virus-associated nephropathy can progress to renal allograft loss. Monitoring for this serious risk and early intervention by the healthcare provider is critical. Adjustments in immunosuppression therapy should be considered for patients who develop BK virus-associated nephropathy. The association of BK virus-associated nephropathy has previously been reported for tacrolimus (Prograf). Information about the increased risk for opportunistic infections, including activation of latent viral infections, is included in the prescribing information for tacrolimus. Currently the prescribing information for the other immunosuppressant drugs does not adequately warn about this possible serious adverse event. Based on this new safety information, the FDA is requiring, under the authorities granted under the Food and Drug Administration Amendments Act (FDAAA) of 2007, that manufacturers of these immunosuppressants update their prescribing information to include stronger warnings about the risk of BK virus-associated nephropathy. The FDA urges both healthcare professionals and patients to report side effects from the use of immunosuppressant drug products to the FDA's MedWatch Adverse Event Reporting program: 1-800-332-1088 - Tel 1-800-FDA-0178 - Fax Regular Mail: Use postage-paid FDA Form 3500 Mail to: MedWatch 5600 Fishers Lane Rockville, MD 20852-9787 SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version