FDA Orders Stronger Warning Labels for Some Kidney Transplant Rejection Drugs

The Food and Drug Administration is requiring manufacturers of six immunosuppressant drugs used to reduce rejection in kidney transplant patients to include stronger label warnings about the increased risk of infections.

Drugs that lower the body’s immune system to reduce the risks that the body will reject a newly implant kidney or other organ also have the unfortunate side effect of leaving patients more susceptible to potentially life-threatening infections.

The drugs covered by the FDA order for stronger warnings about infection risks are:

• Rapamune (sirolimus)

• Sandimmune (cyclosporine) and cyclosporine generics

• Neoral (cyclosporine modified), and generics

• Cellcept (mycophenolate mofetil) and generics

• Myfortic (mycophenolic acid)

Reports of adverse events in people taking the immunosuppressant drugs prompted today’s FDA crackdown. The labeling on the drugs must now advise users of the increased risk of opportunistic infections, including latent viral infections that become reactivated in patients taking the drugs. BK virus-associated nephropathy, which is most common in patients who have undergone kidney transplants, can result in serious health complications, including kidney graft loss, the FDA said.

The FDA is requiring the labeling changes based on its review of reported adverse events. The labeling changes must reflect the reported increased risk for opportunistic infections, including activation of latent viral infections. These include BK virus-associated nephropathy, which can mainly affect kidney transplant patients. Such infections may lead to serious outcomes, including kidney graft loss.

The immunosuppressive drug Prograf (tacrolimus) already carries stronger labeling warnings about the risks of opportunistic infections.

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