Drug & Device News

Although it may have seemed an obvious concern, certain immunosuppressant drugs were not, until July, required to carry warnings that their use could increase a patient's risk for developing opportunistic infections, such as latent viral infections. Of primary concern is BK virus-associated nephropathy, a kidney disease that is being seen in renal transplant patients. Most healthy adults have at one time contracted the BK virus, which remains in their kidneys and urinary tracts indefinitely, generally causing no harm. However, when the immune system is suppressed or otherwise compromised, the virus can replicate. On July 17, based on what the FDA termed new safety information, the agency announced that, from now on, the manufacturers of the following immunosuppressants must update their prescribing information to include stronger warnings about the risk of BK virus-associated nephropathy:

• Sirolimus, marketed as Rapamune;
• Cyclosporine, marketed as Sandimmune and generics;
• Cyclosporine, modified marketed as Neoral and generics;
• Mycophenolate mofetil, marketed as Cellcept and generics; and
• Mycophenolic acid, marketed as Myfortic.

The FDA advises that BK virus-associated nephropathy can progress to renal allograft loss, so medical professionals should monitor patients carefully and consider adjusting their immunosuppression therapies if BK virus-associated nephropathy develops.