FDA Wants Stronger Warnings on Immunosuppressants

From MedPage Today:

The FDA will require beefed up warning labels for a group of immunosuppressant drugs commonly used to prevent organ rejection in kidney transplant patients.

The FDA said its review of postmarketing data found that use of the drugs can lead to an increase in opportunistic or latent infections, such as the BK virus, which is associated with nephropathy, or even kidney graft loss.

The required label changes affect the following immunosuppressant drugs:
  • sirolimus (Rapamune)
  • cyclosporine (Sandimmune) and cyclosporine generics
  • cyclosporine modified (Neoral), and generics
  • mycophenolate mofetil (Cellcept) and generics
  • mycophenolic acid (Myfortic)
The label for the immunosuppressant drug tacrolimus (Prograf) already carries the stronger warning language.

Posted: 7/15/2009 9:16:00 AM

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