Labels for the drugs CellCept, Rapamune, Myfortic, Sandimmune and Neoral are being updated to reflect a higher risk of opportunistic infections, including BK virus-associated nephropathy (kidney damage). The drugs are given to transplant patients to prevent organ rejection.
According to a statement on the Food & Drug Administration’s (FDA) website, the decision to update the labeling for CellCept, Rapamune and the other drugs followed an analyses of its Adverse Event Reporting System (AERS) to characterize 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 kidney transplant patients, the FDA said. The virus can be serious enough to cause rejection of the kidney.
The FDA advised health care professionals that monitoring for this serious risk and early intervention by the health care provider is critical. Adjustments in immunosuppression therapy should be considered for patients who develop BK virus-associated nephropathy.
According to the FDA statement, the association of BK virus-associated nephropathy has previously been reported for another immunosuppressant drug, tacrolimus (marketed as Prograf). Information about the increased risk for opportunistic infections, including activation of latent viral infections, is included in the prescribing information for Prograf. 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, 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.
This is not the first time some of these drugs have been associated with a risk of opportunistic infections. Last year, the labeling for CellCept and Myfortic were updated to Progressive Multifocal Leukoencephalopathy (PML). PML is caused by a polyomavirus, called the JC virus. Most adults have been infected with the JC virus but do not develop PML. The virus appears to remain inactive until something (such as a weakened immune system) allows it to be reactivated and start to multiply.
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