FDA Demands Label Changes to Immunosuppressant Drugs Used in Kidney Transplants

The US FDA recently announced that it will demand that some immunosuppressant drug manufacturers used in kidney (renal) transplants update their labels to disclose a increased risk of infection.

The label requirements effect the following immunosuppressant drugs used to curb transplant organ rejection:

Rapamune (Sirolimus)

Sandimmune (Cyclosporine and Cyclosporine generics)

Neoral (Cyclosporine modified and generics)

Cellcept (Mycophenolate and Mofetil and generics)

Myfortic (Mycophenolic Acid)

Based on the FDA’s review on reported side-effects, the labels changes have become a requirement.  The label changes must communicate a reported increase risk for opportunistic infections, which include activation of latent viral infections.  This includes BK virus-associated nephropathy, which affects kidney transplant patients.  Such an infection may prompt serious outcomes such as kidney graft loss.